1. Home
  2. News
  3. Health News
  4. FDA Drug Approvals

FDA Drug Approvals

Recent Articles

Sort by:

U.S. Statin Costs Are 400% Higher Than UK's

Costs highest for those with private health insurance

If you live in the U.S. and take a statin to lower your cholesterol, you're paying a premium price for that drug.

That's the conclusion of the Boston University School of Medicine (BUSM) Boston Collaborative Drug Surveillance Program, which found the cost of statins for people in the U.S. under the age of 65 who have private insurance is approximately 400 percent higher than comparable costs paid by the government in the United Kingdom.

The cost of prescription drugs remains a large part of the ongoing debate on the costs of medical care in the U.S. and U.K. Because of the many variables that contribute to these costs, well-defined estimates of the actual and relative usage and costs for the two countries have not been reliably documented, the researchers said.


Statins are popular but have rare and potentially severe adverse effects, particularly muscle damage, and some doctors believe they are overprescribed. A 2010 Johns Hopkins study of 950 healthy men and women has shown that taking daily doses of a statin medication to protect coronary arteries might not provide additional protection.

Lipitor, one of the most widely prescribed statins, just went generic, but it may be a few years before its price falls significantly. It's price before going generic was well over $1,000 a year.

Statins were prescribed to an estimated 32.7 percent of people in the U.S. and 24.4 percent in the U.K. In the U.S. the estimated annual cost of statins ranged from a high of $1,428 for simvastatin (generic unavailable), to a low of $314 for lovastatin (available in generic formulation).

In the U.K. the annual cost varied from a high of $500 for atorvastatin (generic not available), to a low of $164 for simvastatin (available in generic). The estimated cost per pill was at least twice as high for each statin prescribed in both countries.

When you don't pay, you don't care what it costs

Are American patients that much richer than their British counterparts, that they can afford to shell out $1,400 a year for a prescription drug? Not really. But the point is, they aren't paying for it directly. With so many health plans now providing prescription coverage, American patients often get very expensive drugs for a low co-pay. The actual cost is reflected in higher premiums and shifted to patients without drug coverage.

When the annual cost for each annual statin user together with the number of users were combined, the total estimated cost for statin users was $69.5 million in people covered by private insurance companies in the U.S. The total estimated annual cost for statin users covered by the government in the U.K. was $15.7 million.

"In addition to differences in overall statin use and per unit costs, another significant factor contributing to the disparity of costs appears to be the availability and utilization of generics," said lead author Hershel Jick, MD, Director Emeritus of BUSM's Collaborative Drug Surveillance Program and associate professor of medicine at BUSM.

Generics prove popular

According to the researchers, simvastin was approved in the U.S. for sale in generic formulation in late June 2006. Within the next six months more than 60 percent of users switched from the brand preparation to the generic.

The resulting estimated cost was reduced more than 60 percent. According to the researchers, however, it still was four times higher than that in the UK.

A comparison on U.S. and UK statin costs...
Read lessRead more

FDA Approves Drug to Treat Two Rare Disorders

Rituxan shown to help patients with blood vessel inflammation

TheU.S. Food and Drug Administrationhas approved Rituxan (rituximab) to treat patients with Wegenergranulomatosis (WG) and microscopic polyangiitis (MPA), two rare disorders that cause blood vessel inflammation (vasculitis).

Rituxan will be usedin combination with steroids.

Vasculitis in patients with WG and MPA can lead to tissue damage. WG mostly affects the respiratory tract (sinuses, nose, trachea, and lungs) and kidneys, while MPA commonly affects the kidneys, lungs, nerves, skin, and joints.

Both of these diseases affect people of all ages and ethnicities, and both genders. The causes of these disorders are unknown, and both are considered orphan diseases because they each affect less than 200,000 people in the United States.

This new indication for Rituxan provides the first approved therapy for these two orphan diseases,said Curtis Rosebraugh, M.D., M.P.H., director of the Office of Drug Evaluation II in the FDA?Center for Drug Evaluation and Research.

Rituxan is an antibody that is manufactured through biotechnology methods. The drug works by greatly reducing the number of specific immune cells in the blood, known as B cells. 

The safety and effectiveness of Rituxan was demonstrated in a single controlled trial, in which 197 patients with WG or MPA were assigned at random to receive either Rituxan plussteroids once a week for four weeks or oral cyclophosphamide plus steroids daily to induce remission. After six months, 64 percent of patients treated with Rituxan had complete remission compared to 53 percent of patients treated with cyclosphosphamide. 

Retreatment with Rituxan was not formally evaluated; therefore, the safety and efficacy of retreatment with subsequent courses of Rituxan has not been established. More data are needed to determine the safety of more than one course of Rituxan and long term safety of use of Rituxan in patients with WG and MPA. These questions will be further evaluated in a required post-marketing study.

Rituxan carries a Boxed Warning for infusion reactions, which can occur during infusion or within 24 hours afterwards. Other Boxed Warnings for Rituxan include rashes and sores in the skin and mouth (severe mucocutaneous reactions); and progressive multifocal leukoencephalopathy, a brain infection that generally is fatal. Rituxan is not recommended for use in patients with severe, active infections.

The most common side effects in study participants with WG and MPA included infection, nausea, diarrhea, headache, muscle spasms, and anemia.

Rituxan, which has been marketed since 1997, is also indicated for the treatment of patients with non-Hodgkin'slymphoma, chronic lymphocytic leukemia, and rheumatoid arthritis.

Rituxan is manufactured by San Francisco-based Genentech, a member of the Roche Group.

FDA Approves Drug to Treat Two Rare Disorders Rituxan shown to help patients with blood vessel inflammation...
Read lessRead more

Cheap Generics Key To Savings On Health Care?

Savings could be huge, study says

What if one of the answers to skyrocketing healthcare costs were right in front of us, but we just don't see it? That's a question posed by a University of Pittsburgh study, published in the Archives of Internal Medicine.

In the study, researchers suggest that if everyone who was eligible took advantage of a $4 generic drug program, offered by a number of drug stores, the total savings could amount to $6 billion.

$4 generics

Wal-Mart started the $4 generic drug program several years ago and now, many other national drug store and pharmacy chains have similar programs. If a patient's prescription can be substituted for one of the generics on the list, the consumer pays just $4 each time the prescription is filled.

The study examined a large group of people who used generic medications or their brand-name counterparts - drugs like lovastatin or prescription-strength ibuprofen - that also were available for $4 per 30-day supply through a discounted generic drug program.

Despite the very significant savings offered by the generics, the study found that among the patients taking these medications, less than 6 percent used the $4 generic medication programs in 2007. They passed up these savings even though average prescription drug coverage plans ask patients to pay about $10 per 30-day supply for generic drugs and about $25 per 30-day supply for brand-name medications.

$5.8 billion in potential savings

If all eligible patients used the discount programs in 2007, the researchers say society would have saved $5.8 billion on prescription drug spending. Why do consumers pass up this savings? The study doesn't address that, though researchers suggest the individual savings, on a case-by-case basis, might not seem that large.

"Although just half of the potential users of the $4 programs would have saved more than $22 a year in out-of-pocket expenses, the societal savings are great. This suggests the majority of savings comes from a small proportion of individuals," said the study's lead author, Yuting Zhang, Ph.D., assistant professor of health policy and management, at the University of Pittsburgh.

The researchers conclude that some of the answers to ever-expensive health care may, in fact, be simple. And consumers looking for ways to trim their budgets in these tight times should check to see if their prescriptions are available for $4.

"We are not promoting any specific pharmacy or any retail store's discount generic medication program," Zhang said. "However, if policy makers and clinicians direct patients to low-cost generic programs, patients and taxpayers could save tremendously."

Consumers looking for ways to cut spending should take advantage of $4 generic drug prescriptions...
Read lessRead more

Osteoporosis Drug Reclast Linked to Kidney Failure

Public Citizen wants FDA to warn physicians, consumers

Does Canada care more about its citizens' health than the U.S.? It sometimes looks that way.

The consumer group Public Citizen wants the U.S. Food and Drug Administration to do what Canada apparently did five months ago – tell Novartis to warn physicians and consumers about a dangerous link between a widely-used osteoporosis drug and serious renal toxicity, which can result in death.

In a letter to the FDA, Public Citizen's Health Research Group said the Canadian government reacted after learning of 265 cases of serious kidney impairment in patients using Aclasta (zoledronic acid). The drug is called Reclast in the U.S. and is identical to the Canadian version.

Five months later, the FDA has done nothing, said Public Citizen's Sidney Wolfe, M.D., in a letter to FDA Commissioner Margaret Hamburg, M.D.

The Food and Drug Administration (FDA) has failed to take ... action requiring Novartis to alert physicians and patients in the United States about the growing evidence linking Reclast to this serious, life-threatening adverse event,” Wolfe said. “We therefore urge the FDA to immediately require that Novartis issue a similar “Dear Doctor Letter” to all physicians in the U.S.”

Reclast is given once a year for treatment of osteoporosis in men and postmeopausal women and once every two years for prevention of osteoporosis in postmenopausal women.

Wolfe noted that more than one million infusions of Aclasta had been administered worldwide as of October 2010. The 265 cases of renal impairment reported in Canada corresponds to a rate of about 20 cases per 100,000 patient-years of exposure. The FDA estimates that no more than 10 percent of adverse drug reactions are reported.

Clearly, the current warnings and precautions in the FDA-approved label for Reclast about the risk of renal impairment are not sufficient for making physicians adequately aware of this serious, life-threatening renal toxicity associated with Reclast, the very reason that the Canadian government convinced the company to initiate the additional warnings,” Wolfe said..

Osteoporosis Drug Reclast Linked to Kidney Failure. Public Citizen wants FDA to warn physicians, consumers....
Read lessRead more

FDA Plans to Remove Unsafe Drugs from the Market

Some of the targeted drugs are dangerous, others simply ineffective

Certain unapproved prescription medicines intended to relieve cough, cold and allergy symptoms could do you more harm than good.

As a result, the Food and Drug Administration (FDA) says it intends to remove them from the U.S. market.  That won’t leave you hacking and wheezing, though. The agency says there are other products available — including FDA-approved prescription drugs or over-the-counter drugs that follow appropriate standards.

These products being have not been evaluated by FDA to assure that they are safe, effective, and of good quality. They may therefore pose unnecessary risk to consumers, especially when there are other products available for treatment of cough, cold, and allergy symptoms, including FDA-approved prescription drugs or over-the-counter drugs that follow appropriate FDA standards.

Complaints, problems and confusion

FDA officials say they have numerous concerns about these products that have not been evaluated by the agency. Some may have potentially risky combinations of ingredients, while others — marketed as “timed-release” — may release active ingredients too slowly, too quickly or inconsistently.

FDA has also received reports that some of the products have names that look or sound similar to other products — a problem that could contribute to medication errors.

In addition, FDA health experts are concerned that some of the products are inappropriately labeled for use by infants and young children. Many of the unapproved drug products covered by the announcement contain the same ingredients as the over-the-counter cough and cold products that were the subject of a 2008 FDA public health advisory.

That advisory said non-prescription cough and cold products should not be used for infants and children under two years of age because of serious and potentially life-threatening side effects. Many manufacturers voluntarily withdrew products labeled for children under two-years-old, and some products were relabeled to state that they were not for use by children under four-years-old.

Safe and effective drugs

Removing these unapproved products from the market will reduce potential risks to consumers from products that have never been evaluated by the FDA for safety, effectiveness, and quality,” says Deborah Autor, compliance director at FDA’s Center for Drug Evaluation and Research.

FDA says most manufacturers affected by this action must stop making the products within 90 days and stop shipping them within 180 days. (Some manufacturers may have to stop making and shipping their products immediately.)

Autor says taking them off the market shouldn’t create problems for consumers because there are many other products — both prescription and over-the-counter — available for treatment of cough, cold, and allergy symptoms that meet FDA standards.

Some of the prescription medicines being removed have been marketed for many years. Over the past century, the laws outlining the requirements for drug approval have changed. First, drug regulation focused on adulteration and misbranding, but did not require that new drug products be approved prior to being marketed. Then, laws on drug regulation changed to include drug safety as a requirement for approval.

Currently, the law requires that new drugs be shown to be safe, effective, of good manufacturing quality, and not misbranded prior to being approved by FDA for marketing in the United States. In part, as a result of these changes in the law, many of the products that are the focus of this action have been marketed without being approved under the current legal requirements.

Approved drug lists

If you are taking a prescription medicine for cough, cold, or allergy symptoms and you want to know if it is an approved drug, use one of the FDA resources listed below. (These resources do not include many over-the-counter drugs because many of these drugs do not require FDA approval to be legally marketed.)

  • Drugs@FDA (contains most FDA-approved drug products): If a product is not included here, the search results will say, “Your search term did not return any results.”

  • The Orange Book List of Approved Drug Products: If a product is not FDA approved, the search results will say, “No matching records found.”

  • The National Drug Code (NDC) directory of prescription drugs and insulin products: Search results include a column marked “Appl No.”  FDA-approved products will have an associated NDA (new drug application) or ANDA (abbreviated new drug application) number in this column.

If you are taking one of the unapproved prescription medications that are affected by this FDA action, discuss alternatives with your health care provider. To dispose of your unused, unapproved prescription cold, cough, or allergy products, please see this link.

FDA Plans to Remove Unsafe Drugs from the Market...
Read lessRead more

Faster Generic Drug Approval May Not Lower Prices

Could make production more expensive, researcher says

When a name-brand drug goes generic, it means other drug companies can start producing it, not just the firm that held the original patent. That can mean the drug will cost less, though that's not always the case.

Andrew Ching, a Canadian market researcher, has conducted a study that shows faster approval times for generic drugs will get them into consumers' hands quicker, but may not make the price any cheaper. Ching contends that speeding up the generic approval process actually keeps the price from being as low as it could be.

As part of his research, Ching created a mathematical model showing that fewer firms enter the marketplace because the chances of getting there first and commanding the best profits are dramatically smaller when drug approval times are shorter.

Ching is an associate professor of marketing at the University of Toronto's Rotman School of Management.

Using the drug clonidine, Ching's model showed the number of firms in the marketplace dropped by 25 percent -- from 12 to nine -- under a shortened approval time scenario.

Faster not necessarily cheaper

"Potentially, for the consumer, the price may not drop as much as you'd hope," said Ching.

It normally takes companies an average of more than 20 months to get U.S. Food and Drug Administration (FDA) approval for generic versions of established drugs. That makes approval times uncertain and companies often must go through several rounds of review.

Companies also pay several million dollars when they apply for FDA approval. Given these as well as other development costs, firms making it to the marketplace last sometimes experience losses.

Wrong approach?

Chaig says his research is relevant because the FDA has actively tried to reduce generic approval times in order to benefit consumers, and has proposed strategies for how to do it -- including spending more money in order to bring on extra staff to do the reviews.

Ching says his results, which were published in International Economic Review, suggest the FDA should think twice before going that route.

"Even if the government spends a large amount of resources to improve the efficiency of the FDA in approving generic drugs, it does not necessarily achieve the goal of enhancing welfare," Ching's said.

The FDA would like to get generic drugs into consumers' hands faster, but a researcher contends that might not be much of a benefit....
Read lessRead more

Darvon and Darvocet Being Pulled From American Market

The painkilling medication poses a risk of fatal heart abnormalities

Xanodyne Pharmaceuticals Inc., the maker Darvon and Darvocet -- the brand version of the prescription pain medication propoxyphene -- has agreed to withdraw the medication from the U.S. market.

The move comes at the request of the Food and Drug Administration (FDA), which has also informed the generic manufacturers of propoxyphene-containing products of Xanodyne's decision and requested that they voluntarily remove their products as well.

Risk of heart problems

The FDA sought market withdrawal of propoxyphene after receiving new clinical data showing the drug puts users at risk of potentially serious or even fatal heart rhythm abnormalities. As a result of these data -- combined with other information, including new epidemiological data -- the agency concluded that the risks of the medication outweigh the benefits.

"The FDA is pleased by Xanodyne's decision to voluntarily remove its products from the U.S. market," said John Jenkins, M.D., director of the Office of New Drugs in FDA's Center for Drug Evaluation and Research (CDER). "These new heart data significantly alter propoxyphene's risk-benefit profile. The drug's effectiveness in reducing pain is no longer enough to outweigh the drug's serious potential heart risks."

Doctors notified

The FDA is advising health care professionals to stop prescribing propoxyphene to their patients. Anyone currently taking the drug should contact his or her health care professional as soon as possible to discuss switching to another pain management therapy.

Propoxyphene is an opioid used to treat mild to moderate pain. First approved by the FDA in 1957, the drug is sold by prescription under various names both alone (e.g., Darvon) or in combination with acetaminophen (e.g., Darvocet).

New information

Since 1978, the FDA has received two requests to remove propoxyphene from the market. Until now, the agency had concluded that the benefits of propoxyphene for pain relief at recommended doses outweighed the safety risks of the drug.

In January 2009, the FDA held an advisory committee meeting to address the efficacy and safety of propoxyphene. After considering the data submitted with the original drug applications for propoxyphene, as well as subsequent medical literature and postmarketing safety databases, the committee voted 14 to 12 against the continued marketing of propoxyphene products.

In making this recommendation, the committee noted that additional information about the drug's cardiac effects would be relevant in weighing its risks and benefits.

European precedent

In June 2009, the European Medicines Agency (EMEA) recommended that the marketing authorizations for propoxyphene be withdrawn across the European Union. A phased withdrawal of propoxyphene is underway.

In July 2009, the FDA decided to permit continued marketing, but required that a new boxed warning be added to the drug label alerting patients and health care professionals to the risk of a fatal overdose. In addition, the agency required Xanodyne to conduct a new safety study assessing unanswered questions about the effects of propoxyphene on the heart.

Further review

The agency now has reviewed the data from that study, which show that, even when taken at recommended doses, propoxyphene causes significant changes to the electrical activity of the heart. These changes, which can be seen on an electrocardiogram (EKG), can increase the risk for serious abnormal heart rhythms that have been linked to serious adverse effects, including sudden death.

The available data also indicate that the risk of adverse events for any particular patient (even patients who have taken the drug for many years) is subject to change based on small changes in the health status of the patient, such as dehydration, a change in medications, or decreased kidney function.

"With the new study results, for the first time we now have data showing that the standard therapeutic dose of propoxyphene can be harmful to the heart," said Gerald Dal Pan, M.D., M.H.S., director of the Office of Surveillance and Epidemiology, CDER. "However, long-time users of the drug need to know that these changes to the heart's electrical activity are not cumulative. Once patients stop taking propoxyphene, the risk will go away."

Xanodyne is based in Newport, Ky.

Darvon and Darvocet Being Pulled From American MarketThe painkilling medication poses a risk of fatal heart abnormalities...
Read lessRead more

FDA Bans Unapproved Gout Medicine

Oral colchicine has been used to prevent gout and treat gout flare-ups

Companies that manufacture, distribute or market unapproved single-ingredient oral colchicine, a medication commonly used for the daily prevention of gout, to treat acute gout flare-ups, and for the treatment of Familial Mediterranean Fever (FMF) may no longer do so.

The Food and Drug Administration (FDA) has told the companies they must to stop manufacturing single-ingredient oral colchicine within 45 days and stop shipping it in interstate commerce within 90 days. A small amount of unapproved colchicine is expected to be available after these dates until supplies are exhausted.

Many single ingredient oral colchicine products have been used by the medical community for decades. These and a variety of other medications have not received the mandatory modern-day FDA-approval required of all prescription drugs.

The exception

Colcrys is the only FDA-approved single-ingredient oral colchicine product available on the U.S. market. Approved by the FDA in 2009, Colcrys' prescribing information contains important safety data and recommendations on drug interactions and dosing not available with unapproved products.

The manufacturer of Colcrys, Mutual Pharmaceutical/URL Pharma, has established a Patient Assistance Program (PAP) and a Co-Pay Assistance Program (CAP) to ensure that all patients will be able to continue affordable access to colchicine. The company also has informed FDA that it will maintain the programs at a minimum until there is FDA-approved generic competition for Colcrys.

The PAP covers three groups of people: those with insurance; those without insurance; and Medicare beneficiaries enrolled in Part D who do not want the cost of Colcrys to contribute toward their true out-of-pocket expenditures under Part D. The CAP helps eligible patients reduce their Colcrys prescription co-pay to no more than $25 per prescription. Specific information on these programs can be found at here, and here or by calling 1-888-811-8423.

Safety a priority

"The need for drugs to go through the FDA approval process is clearly demonstrated by our review of oral colchicine tablets," said Janet Woodcock, M.D., director of FDA's Center for Drug Evaluation and Research (CDER). "Without our safety review and proper drug labeling, the old standard of care would likely have continued, to the detriment of patients."

Unapproved versions of colchicine are not generic drugs. Generic drugs are approved by the FDA to assure that the approved generic drug products meet the same standards as the innovator drug. All single-ingredient oral colchicine products -- other than Colcrys -- that are currently being marketed are unapproved drugs and have never been evaluated by the agency.

"It is a priority for the FDA to get unapproved medications, such as older versions of single ingredient oral colchicine, either updated to conform to FDA's current approval standards or off the market," said Deborah M. Autor, director of CDER's Office of Compliance. "The FDA remains committed to ensuring that prescription drugs have the necessary FDA approval. We encourage companies to actively pursue approval or face the type of action announced today."

The FDA previously took action against unapproved colchicine for injection products on Feb. 6, 2008. This continuing initiative is designed to bring all unapproved medications -- including single-ingredient oral colchicines -- up to modern-day safety, efficacy, labeling, and quality standards by ensuring that they comply with FDA approval requirements, officials stressed.

The Food and Drug Administration (FDA) has told companies they must to stop manufacturing single-ingredient oral colchicine within 45 days....
Read lessRead more

Multiple Sclerosis Patients Get Their First Oral Drug

FDA approves Gilenya capsules, first MS drug taken by mouth

The U.S. Food and Drug Administration has approved Gilenya capsules to reduce relapses and delay disability progression in patients with relapsing forms of multiple sclerosis (MS), a disorder usually treated with injections and infusions.

Gilenya is the first oral drug that can slow the progression of disability and reduce the frequency and severity of symptoms in MS, offering patients an alternative to currently available injectable therapies, said Russell Katz, M.D., director of the Division of Neurology Products in the FDAs Center for Drug Evaluation and Research.

Gilenya, made by Novartis AG, is the first in a new class of drugs that block some blood cells in lymph nodes, reducing their migration to the brain and spinal cord, which may help with reducing the severity of MS.

The drug has also been approved in Russia and is awaiting approval in other countries. Merck is now selling a similar MS drug, cladribine, in Australia and Russia and is expecting approval in the U.S. later this year.

MS is a chronic, often disabling, disease that affects the central nervous systemthe brain, spinal cord, and optic nerves. According to the National Multiple Sclerosis Society, there are about 400,000 people in the United States and 2.1 million people worldwide with MS.

The progress, severity, and specific symptoms of MS are unpredictable and vary from one person to another. Symptoms can be mild, such as numbness in the limbs, or severe, such as paralysis or loss of vision.

Patients using Gilenya should be monitored for a decrease in heart rate upon starting the drug. Gilenya may also increase the risk of infections. Cases of serious eye problems (macular edema) have occurred in patients taking the drug and an ophthalmologic evaluation is recommended.

The most frequent adverse reactions reported by patients taking Gilenya in clinical trials include headache, influenza, diarrhea, back pain, elevation of certain liver enzymes and cough.

The drug will be available in 0.5 milligram capsules.

Read more about Multiple Sclerosis.

Multiple Sclerosis Patients Get Their First Oral Drug...
Read lessRead more

New Treatment For Gout Approved

Targeted at adults who don't respond to traditional treatments

Adults suffering from gout now have a new treatment. The U.S. Food and Drug Administration has approved Krystexxa (pegloticase) to treat the painful condition in adults who do not respond to or who cannot tolerate conventional therapy.

Gout occurs due to an excess of the bodily waste uric acid, which is eventually deposited as needle-like crystals in the joints or in soft tissue. These crystals can cause intermittent swelling, redness, heat, pain and stiffness in the joints.

Gout is strongly associated with obesity, high blood pressure, high cholesterol and diabetes, and occurs more often in men, in women after menopause, and in people with kidney disease.

"About three percent of the three million adults who suffer from gout are not helped by conventional therapy. This new drug offers an important new option for them," said Badrul Chowdhury, M.D., director of the Division of Pulmonary, Allergy, and Rheumatology Products in the FDA's Center for Drug Evaluation and Research.

Metabolizes uric acid

For patients with gout, the conventional therapy is to receive drugs that lower the amount of uric acid in the blood -- for example, the xanthine oxidase inhibitors Zyloprim (allopurinol) and Uloric (febuxostat). Krystexxa is an enzyme that lowers uric acid levels by metabolizing it into a harmless chemical that is excreted in the urine. The drug is administered to patients every two weeks as an intravenous infusion.

Two six-month clinical trials of 212 total patients demonstrated that the drug lowered uric acid levels and reduced deposits of uric acid crystals in joints and soft tissue, the FDA said.

Since one out of every four patients in the clinical trials experienced a severe allergic reaction when receiving an infusion of Krystexxa, health care providers should dispense a corticosteroid and an antihistamine to their patients beforehand to minimize the risk of such a reaction, the agency advised. Other reactions during the clinical trials included gout flare, nausea, injection site bruising, irritation of the nasal passages, constipation, chest pain and vomiting.

Physicians are also being warned to be cautious about administering Krystexxa to patients with congestive heart failure because the drug was not studied in this patient population.

Krystexxa is being approved with a Risk Evaluation and Mitigation Strategy that includes a medication guide for patients and materials for healthcare providers to communicate the risk of severe infusion and allergic reactions. The drug is manufactured by Savient Pharmaceuticals Inc. of East Brunswick, N.J.

New Treatment For Gout Approved...
Read lessRead more

Clinical Trial Confirms Health Risks of Meridia

Diet drug carries 'significant' risk of heart attack and stroke

By Truman Lewis

September 13, 2010
A clinical trial of Meridia finds that the controversial diet pill not only raises the risk of heart attacks and strokes but also doesn't do much to trim excess weight. European regulators have ordered the drug removed from the market but the U.S. Food and Drug Administration (FDA) continues to move more gingerly.

The FDA has asked a panel of experts to make recommendations about the drug, but isn't bound by the panel's recommendations. The consumer group Public Citizen has been pressuring the FDA to ban Meridia for years, with no success.

Last December, Public Citizen cited early results of the clinical trial, known as "SCOUT," showing that Meridia caused a "significantly increased number" of heart attacks and strokes, the second time in four years it had asked the FDA to withdraw the drug.

The latest study -- financed by Meridia manufacturer Abbott Labs and published in the New England Journal of Medicine -- found that while the drug did raise the risk of heart attacks and strokes, Meridia's label already warned against the use of the drug in patients with heart problems.

But that didn't stop the editors of the Journal from writing an unusual editorial saying that the study clearly showed Meridia should be removed from the market.

The editors didn't challenge the study's findings but said the authors didn't go far enough, noting that many overweight persons may have cardiovascular disease without realizing it and might therefore be putting themselves at risk by using the medication.

The FDA's cautious approach reflects the view that medications that may be beneficial to some individuals should not be banned because of the damage they may or may not cause to others but the agency's critics don't buy it.

If the FDA truly intends to operate as a public health agency, then it should acknowledge that the continued approval of this drug cannot be justified based on science, said Dr. Sidney Wolfe, director of Public Citizens Health Research Group said last year. The FDA should therefore tell Abbott to pull Meridia from the market immediately.

Public Citizen first petitioned the FDA to ban sibutramine, the active ingredient in Meridia, on March 19, 2002. The organization based its request on results of pre-approval clinical trials that demonstrated increases in blood pressure, pulse rate and palpitations in obese patients taking the drug.

Despite scientific evidence that these patients were three times more likely to experience clinically significant electrocardiogram changes than obese patients taking placebos - coupled with the minimal benefit of an average six-and-a-half pound weight-loss difference between the two groups - the FDA approved the drug in 1997.

By March 2003, there were reports to the FDAs adverse reaction system of 49 cardiovascular deaths among patients taking Meridia. Twenty-seven of the 49 (55 percent) were in people younger than 50 years old. The number is likely higher, as the FDA estimates that only one in 10 adverse reactions to drugs are reported to the agency.

Based on the findings from the SCOUT study and Public Citizens updated figures based on an analysis of FDA data, Public Citizen calculates that there have been 84 post-approval cardiovascular deaths of patients taking Meridia. This includes 32 patients who were 50 or younger and 11 patients 30 or younger.

Clinical Trial Confirms Health Risks of Meridia...
Read lessRead more

Public Citizen to FDA: Pull Fibromyalgia Drug from the Market

Medication has limited efficacy, risky effects, group says

Public Citizen is calling on the Food and Drug Administration (FDA) to pull the fibromyalgia drug Savella from the market immediately.

In its petition to the FDA, Public Citizen notes that the European Medicines Agency (EMEA), which regulates drugs on the Continent, rejected Savella's approval for fibromyalgia in July 2009, stating that its benefits were "marginal" and "did not outweigh its risks." This was shortly after the FDA approved the drug in January 2009.

Since the drug went on the market in the U.S., approximately 250,000 prescriptions have been filled, with doctors writing more prescriptions every month.

In two randomized clinical trials, Savella, also known by its generic name milnacipran, was found to increase blood pressure, heart rate and suicidal thoughts, Public Citizen's petition said. Among patients who had normal blood pressure at the beginning of the study, 19.5 percent of those who took Savella developed hypertension, compared with 7.2 percent of those on a placebo.

"Because Savella is a drug that produces only a marginal effect on pain, the main problem for which patients seek treatment, and has the potential to be quite dangerous, it is clear that it should not be sold," said Dr. Sidney Wolfe, director of Public Citizen's Health Research Group. "The FDA never should have approved Savella for fibromyalgia and should now immediately order the drug company to remove it from the market before large numbers of people suffer serious harm," Wolfe said.

Based on the extent of increased blood pressure caused by Savella, the FDA medical officer who reviewed the drug estimated that persistent blood pressure hikes could increase the risk of a cardiovascular event (including death, myocardial infarction and stroke) by up to 50 percent.

Savella also puts patients at risk for other disorders, including seizures, addiction, excessive bleeding, mood disorders, fractures, glaucoma and gastrointestinal effects such as nausea and vomiting. In pregnant women, the drug also can lead to hazards for fetuses, newborns and nursing infants. Additional risks for men include testicular pain and problems with ejaculation. In fact, FDA warned last year of problems with Savella.

The director of the FDA's Division of Anesthesia, Analgesia and Rheumatology Products stated that although the dominant symptom of fibromyalgia is pain, the drug did not relieve patients' pain in the clinical trials.

Fibromyalgia is a chronic disease, but neither of the drug's trials showed any statistical effectiveness beyond three months. And even within the trials' three-month duration, more than 90 percent of users in the trial received no benefit from the drug at all.

Although not marketed as an antidepressant in the U.S., Savella is sold in Europe and Japan as such. The drug is required in the U.S. to have the "black box" warning for antidepressants, which points out an increased risk of suicide in children, adolescents and young adults.

Savella is manufactured by Cypress Bioscience Inc. and Forest Laboratories Inc., and has been sold in the U.S. since May 2009.

Savella is not the only treatment for fibromyalgia. The FDA approved another drug, Lyrica, in 2007.

Public Citizen To FDA: Pull Fibromyalgia Drug From The Market...
Read lessRead more

Meridia Research Shows increased Stroke and Heart Attack Risk

Public Citizen warns of 'significant' increase in heart attacks, strokes

December 3, 2009
New research shows that Meridia, a popular weight-loss drug, has caused a significantly increased number of heart attacks, strokes, resuscitated cardiac arrests or deaths in obese patients getting the drug and should be pulled from the market immediately, Public Citizen said today in a petition to the Food and Drug Administration (FDA).

This is Public Citizens second petition to have Meridia banned; the FDA rejected the first four years ago, saying it was awaiting results of an ongoing trial. The results are in, and they show that the drugs dangers significantly outweigh its benefits.

If the FDA truly intends to operate as a public health agency, then it should acknowledge that the continued approval of this drug cannot be justified based on science, said Dr. Sidney Wolfe, director of Public Citizens Health Research Group. The FDA should therefore tell Abbott to pull Meridia from the market immediately.

Public Citizen first petitioned the FDA to ban sibutramine, the active ingredient in Meridia, on March 19, 2002. The organization based its request on results of pre-approval clinical trials that demonstrated increases in blood pressure, pulse rate and palpitations in obese patients taking the drug.

Despite scientific evidence that these patients were three times more likely to experience clinically significant electrocardiogram changes than obese patients taking placebos - coupled with the minimal benefit of an average six-and-a-half pound weight-loss difference between the two groups - the FDA approved the drug in 1997.

By March 2003, there were reports to the FDAs adverse reaction system of 49 cardiovascular deaths among patients taking Meridia. Twenty-seven of the 49 (55 percent) were in people younger than 50 years old. The number is likely higher, as the FDA estimates that only one in 10 adverse reactions to drugs are reported to the agency.

New research

In responding to Public Citizens 2002 petition, the FDA said that until a large, randomized study could provide more conclusive results, Meridia would continue to be sold. Now the early results are in from a persuasive study called SCOUT, in which 10,000 people across Europe participated.

The recently released results of this study reveal a significant increase in heart attacks, strokes, resuscitated cardiac arrests or deaths in obese patients 55 or older with known or undetected cardiovascular disease who used sibutramine, compared with those given a placebo. Both groups were on the same weight management program.

Based on the new findings from the SCOUT study and Public Citizens updated figures based on an analysis of FDA data, Public Citizen calculates that there have been 84 post-approval cardiovascular deaths of patients taking Meridia. This includes 32 patients who were 50 or younger and 11 patients 30 or younger.

About 294,000 prescriptions for Meridia were filled in the past 12 months.

Meridia Research Shows increased Stroke and Heart Attack Risk...
Read lessRead more

FDA Orders Stronger Warning Labels on Darvon, Darvocet

Data finds links to fatal overdoses; agency orders new safety study

Perhaps partly satisfying its critics, the U.S. Food and Drug Administration (FDA) says it is taking several actions to reduce the risk of overdose in patients using pain medications such as Darvon and Darvocet that contain propoxyphene. The agency said the actions were taken because of data linking propoxyphene and fatal overdoses.

The consumer group Public Citizen has been calling on the FDA to ban Darvon altogether, saying that the "old pain killer is a plain old killer."

Instead, the agency is requiring manufacturers of propoxyphene-containing products to strengthen the label, including the boxed warning, emphasizing the potential for overdose when using these products. These manufacturers will also be required to provide a medication guide to patients stressing the importance of using the drugs as directed.

In addition, the FDA is requiring a new safety study assessing unanswered questions about the effects of propoxyphene on the heart at higher than recommended doses. Findings from this study, as well as other data, could lead to additional regulatory action.

Physicians need to be aware of the risk of overdose when prescribing these drugs. They should carefully review patient histories and make appropriate treatment decisions based on the warnings and directions stated within the drugs label, said Janet Woodcock, M.D, director of the FDAs Center for Drug Evaluation and Research. Prescribers and patients should be aware of propoxyphenes potential risks when used at doses higher than those recommended. Therefore, the FDA is requiring manufacturers to provide more information to help physicians and patients decide whether propoxyphene is the appropriate pain therapy.

Sidney Wolfe, M.D., director of Public Citizens Health Research Group, testified in January before a Food and Drug Administration (FDA) advisory committee and pointed to information from the Federal Drug Abuse Warning Network (DAWN) in 2007 that found 503 deaths determined by medical examiners to be related to the use of propoxyphene.

Public Citizen first petitioned the FDA to remove the drug from the market in 1978. The organization petitioned a second time in 2006 and, when the FDA failed to take action, Public Citizen sued the agency in 2008.

Propoxyphene has one of the worst benefit-to-risk ratios I have ever seen for a drug, and yet it has long been one of the 25 top-selling drugs in the country, Wolfe said. Pharmacies filled 21 million prescriptions in 2007.

In its announcement today, the FDA said that to "further evaluate the safety" of propoxyphene, the agency plans to work with several groups including the Centers for Medicare & Medicaid Services and the Veterans Health Administration to study how often the elderly are prescribed propoxyphene instead of other pain relievers and the difference in the safety profiles of propoxyphene compared to other drugs.

Propoxyphene manufacturers are required to submit the requested safety labeling changes to the FDA within 30 days, or to provide a reason why they do not believe such changes are necessary. If they do not submit new language, or if the FDA disagrees with the language the companies propose, the Food, Drug, and Cosmetic Act provides strict timelines for discussions regarding the changes. At the end of these discussions, the FDA may issue an order directing the labeling changes as deemed appropriate to address the new safety information.

Also today, the FDA denied a citizen petition from the public interest group Public Citizen requesting a phased withdrawal of propoxyphene.

The agency said in its response that despite the FDAs serious concerns about propoxyphene, the benefits of using the medication for pain relief at recommended doses outweighs the safety risks at this time. The FDA also noted that it plans to further evaluate the safety of propoxyphene and will take additional regulatory action if necessary.

Propoxyphene has been on the market since 1957. It is a widely prescribed member of a group of drugs known as opioids and is used as a treatment for mild to moderate pain. The most frequent side effects of propoxyphene include lightheadedness, dizziness, sedation, nausea, and vomiting.

FDA Orders Stronger Warning Labels on Darvon, Darvocet...
Read lessRead more

Public Citizen Sues FDA for Failure to Act on Darvon

Suit says Darvon is dangerous and no more effective than similar drugs

Public Citizen sued the U.S. Food and Drug Administration (FDA) today for failing to act on its petition to withdraw Darvon, Darvocet and all drugs containing propoxyphene gradually from the market as is now required in the United Kingdom (U.K.).

Public Citizens complaint, filed in the U.S. District Court for the District of Columbia, argues that the FDA is violating the law and putting patients at risk by not acting on Public Citizens Feb. 28, 2006, petition.

Propoxyphene is physically and psychologically addictive, is no more effective than safer alternatives and has been associated with more than 2,000 accidental deaths in America since 1981, Public Citizen told the FDA in its 2006 petition.

Despite the drugs health risks, however, it was one of the 25 most prescribed generic drugs last year, with 22 million prescriptions filled in pharmacies in 2007.

Top FDA drug officials, including Center for Drug Evaluation and Research Director Dr. Janet Woodcock and Dr. Robert Temple, are well aware that this drug has considerable human toxicity, addiction potential and abuse liability, but very limited therapeutic usefulness," said Dr. Sidney Wolfe, director of the Health Research Group at Public Citizen.

"Given this extremely unfavorable ratio of risks to benefits, it is inexcusable that the FDA did not take propoxyphene off the market long ago. It is our hope that this lawsuit will force the agency to finally begin this desperately needed regulatory process.

The U.K. began a phased withdrawal of Darvocet from the British market in 2005, following the recommendation of the U.K. Committee on Safety of Medicines (CSM).

In its report, the CSM stated that it could not identify any patient group in whom the risk-benefit [ratio] may be positive. The withdrawal was completed at the end of 2007.

However, three years after the British government began its action to withdraw the drug, and two years after Public Citizen petitioned for its phasing out, the FDA still has not done anything to protect Americans from propoxyphenes dangerous side effects.

A large proportion of the deaths from propoxyphene occurred because most of the drug is converted into a metabolite that is highly toxic to the heart, lasts longer in the body than the original compound and results in cardiac depression.

Adverse cardiac events associated with propoxyphene include an interruption of heart transmission of electrical impulses, slowed heartbeats and a decreased ability of the heart to contract properly.

Propoxyphene-acetaminophen, or Darvocet, is more dangerous than acetaminophen (the ingredient in Tylenol) alone, yet a study has indicated that Darvocet is no more effective in treating post-operative pain than acetaminophen, Public Citizen said.

Reports on propoxyphene dosage suggest addiction can occur at less than the maximum recommended daily dose and unequivocally confirm addiction at just twice the recommended daily dose.

In addition, propoxyphene has been deemed inappropriate for the elderly because of its adverse effects on the central nervous system - such as sedation and confusion - that have been found to increase the likelihood of falls and fall-related fractures.

Yet studies have shown that propoxyphene use is widespread in emergency rooms, institutionalized populations and retirement communities.

Public Citizen is asking the court to find that the FDAs delay in ruling on the 2006 petition is unlawful and to order the FDA to issue a decision on the petition.

Public Citizen sued the U.S. Food and Drug Administration (FDA) today for failing to act on its petition to withdraw Darvon, Darvocet and all drugs contain...
Read lessRead more

FDA Approves Generic Drug for Restless Legs Syndrome

Requip also approved for treatment of Parkinson's disease

The Food and Drug Administration has approved the first generic versions of a drug for the treatment of moderate to severe Restless Legs Syndrome.

Requip (ropinirole hydrochloride) tablets have been approved in dosages of 0.25 milligram, 0.5 milligram, 1 milligram, 2 milligrams, 3 milligrams, and 4 milligram4.

Roxane Laboratories Inc., Teva Pharmaceuticals USA, Par Pharmaceuticals Inc., and Mylan Pharmaceuticals Inc., have been given the go ahead to market ropinirole hydrochloride tablets.

The labeling of the generic versions of ropinirole hydrochloride may differ from that of Requip because some uses of the drug are protected by patents. In addition to treating Restless Legs Syndrome, Requip is also FDA-approved to treat symptoms of Parkinson's disease.

The generic products are not approved for treatment of Parkinson's disease because this indication is protected by patent. Manufacturers of the generic drugs may seek approval for that use once the patent for the Parkinson's disease indication expires later this month.

The generic ropinirole hydrochloride tablets will have the same safety warnings as Requip, cautioning about patient reports of falling asleep while engaged in activities of daily living, including while driving.

Although many of these patients reported sleepiness while on the drug, some patients perceived that they had no warning signs and believed that they were alert immediately prior to falling asleep. Some of these events have been reported as late as one year after the start of treatment.

FDA Approves Generic Drug for Restless Legs Syndrome...
Read lessRead more

Consumer Reports Pushes For Generic Cholesterol Drug Use

Generic statins just as effective as high-priced spreads

Lipitor is among the most widely prescribed drugs to lower cholesterol, but Consumer Reportssays doctors should consider its price before writing a prescription.

The consumer group says generic statins are as effective as high-priced brands for most people who need a statin drug, and can help consumers save more than $1,000 a year.

"The three generics available to lower cholesterol and help prevent heart attacks can save consumers significant amounts of money, and that is critical for those patients who have trouble paying for their medicines," said Gail Shearer, director of Consumer ReportsBest Buy Drugs. "A person is much more likely to continue taking a needed medicine if they can afford it."

"Generic statins are becoming increasingly less expensive over time," Shearer said. "Every person with high cholesterol or who is at elevated risk of heart attack or stroke should discuss generic statins with their physician, and determine which drug is best for their condition."

The group cites news reports saying that Pfizer, the maker of Lipitor, has been sending letters to doctors to slow the tide of patients switching from that drug to one of the three generic statins. In particular, Lipitor is competing with two new generics -- pravastatin and simvastatin -- that came onto the market late last year. The generics are versions of Pravachol and Zocor, respectively.

Consumer Reports Best Buy Drugs selected lovastatin, pravastatin and simvastatin as "Best Buys" for most types of cholesterol reduction. Lovastatin and pravastatin are recommended if "bad" cholesterol, or LDL, needs to be reduced by less than 30 percent.

Simvastatin is recommended if LDL reduction of 30 percent or greater is needed and/or the patient has had a heart attack or diabetes; or if the patient has had a heart attack and their LDL level is not highly elevated.

Lipitor is a recommended "Best Buy" for a select group of patients -- those who have had a heart attack or have acute coronary syndrome with a highly elevated LDL level. Consumer Reports recommends using the drug for two years and then reconfirming the need or switching to simvastatin after consulting with a physician.

A February analysis of the statin market by CR Best Buy Drugs found that despite the introduction of new generics, the brand-names retained a significant share of all statin prescriptions -- 71 percent. Lipitor alone accounted for an average 43 percent of all statin prescriptions in the latter half of 2006.

Consumer Reports Pushes For Generic Cholesterol Drug Use...
Read lessRead more

FDA Wants Irritable Bowel Drug Shelved

Public Citizen Has Warned of Zelnorm's Dangers for Years

The Food and Drug Administration has told Novartis Pharmaceuticals Corporation that it wants it to suspend marketing of Zelnorm, used to treat irritable bowel syndrome. The agency said it requested the voluntary action based on recent findings of an increased risk of serious heart problems associated with use of the drug.

But Public Citizen says there's nothing recent about and notes that in March 2001, it petitioned the agency not to approve Zelnorm because it was only marginally effective and posed serious safety concerns. Besides heart problems, risks included ovarian cysts and fainting spells.

"We noted in this petition that receptors with which this drug interacts exist not only in the intestinal tract ... but also in the heart," said Dr. Sidney Wolfe, M.D., director of Public Citizen's Health Research Group.

"We pointed out that cisapride, a gastrointestinal drug which also caused fainting and was taken off the market because of cardiac arrhythmias, also affected this same receptor in the heart," Wolfe said.

"Once again, the FDA has approved a drug with marginal effectiveness in the face of serious questions about its safety -- putting at risk the millions of people who have already used it," Wolfe said.

He noted that the FDA has only asked the company to withdraw the drug from the market despite "even clearer evidence of harm.

"This again raises questions about both the adequacy of the FDA's pre-approval review and post-marketing surveillance," Wolfe said..

Zelnorm was approved by the FDA in July 2002 for short-term treatment of women with irritable bowel syndrome whose primary symptom is constipation. It was subsequently approved in August 2004 for treatment of chronic constipation for men and women under age 65. Zelnorm is currently marketed in 55 countries.

There were 2.13 million prescriptions issued for Zelnorm in 2005 alone, making it one of the top 200 drugs in the U.S., according to Public Citizen.

FDA said it advises patients who are using Zelnorm to contact their health care providers to discuss treatment alternatives. Patients who are taking Zelnorm should seek emergency medical care if they experience severe chest pain, shortness of breath, dizziness, sudden onset of weakness or difficulty walking or talking, or other symptoms of a heart attack or stroke, the FDA said.

FDA said it had only recently become aware of the drug's hazards. Its statement did not make any mention of the agency's ignoring Public Citizen's petition six years ago.

"This decision reflects the FDA's commitment to continuously monitor approved drugs throughout their marketing life, and take action when we believe the risks exceed the benefits," said Dr. Douglas Throckmorton, Deputy Director for the Center for Drug Evaluation and Research. "Here, a potential risk of very serious harm to patients who have this non-life-threatening condition was recently identified, making this action necessary."

Throughout February and March 2007, Novartis reported to FDA the results of a new analysis of 29 short-term randomized, controlled clinical trials of Zelnorm. FDA has concluded, based on these data that for most patients the benefits of this drug no longer outweigh the risks, the agency said.

The analysis included more than 11,600 patients treated with Zelnorm and over 7000 patients treated with placebo. The data showed that the risk of serious cardiovascular adverse events (e.g., angina, heart attacks, and strokes) associated with use of Zelnorm is higher than with placebo treatment.

Thirteen Zelnorm-treated patients (or 0.1%) had confirmed cardiovascular ischemic events, and only 1 placebo-treated patient (or 0.01%) with an event.

FDA Wants Irritable Bowel Drug Shelved...
Read lessRead more

FDA Cracks Down on Unapproved Antihistamine

June 12, 2006

The Food and Drug Administration has ordered drug companies making cold, cough and allergy medication containing carbinoxamine, an antihistamine, to stop within the next three months. The agency says carbinoxamine is not approved for use in U.S. medicines, and could be a risk to infants and young children.

The FDA said as many as 26 companies currently produce about 120 medicines containing the unapproved substance. Carbinoxamine is approved for use in only two drugs, both made by Mikart, Inc.

The FDA estimates that there are several hundred different unapproved active ingredients in prescription drugs on the market. The agency estimates that less than 2 percent of prescribed drugs are unapproved.

"Right now, many unapproved drugs represent a public health threat because consumers wrongly assume that these widely marketed and available drugs are approved and have been found to be safe and effective by the FDA," said Acting FDA Commissioner Dr. Andrew von Eschenbach.

"While we want to ensure continued patient access to necessary treatments, as a physician I feel strongly that patients expect and deserve all their prescription medicines to be FDA approved. These unapproved drugs have bypassed the agency approval process through which FDA ensures, based on reliable scientific data, that marketed drugs are safe, effective, properly manufactured, and accurately labeled."

Many of the unapproved drugs affected by the FDA scrutiny are medicines that were developed and marketed before successive changes to the drug approval process that is established in the Federal Food, Drug, and Cosmetic Act.

FDA approval guarantees that a product has been reviewed and will be consistently monitored for safety, effectiveness and adherence with manufacturing quality standards.

"Unapproved drugs may not meet modern standards for safety, effectiveness, quality, and labeling. Clearly this is a problem we intend to fix," said Dr. Steven Galson, Director of FDA's Center for Drug Evaluation and Research.

How could so many unapproved medicines be on the market?

The FDA said health care providers are often unaware of the unapproved status of some drugs and have continued to unknowingly prescribe unapproved drugs because the drugs' labels do not disclose that they lack FDA approval. Often these drugs are advertised in reputable medical journals or are included in widely used pharmaceutical references such as the Physicians' Desk Reference (PDR).

FDA Cracks Down on Unapproved Antihistamine...
Read lessRead more

Big Savings Available As Major Drugs Go Generic

$24.7 Billion in Generic Savings Available This Year

Generic drugs could save U.S. consumers $24.7 billion this year alone, a report finds. The report examined the clinical potential for greater generic drug use in six major drug-therapy classes used to treat common conditions like stomach ulcers, inflammation, depression, high blood pressure and high cholesterol.

The report, issued by pharmacy benefit manager Express Scripts, was based on a random sample of approximately three million individuals projectable to the U.S. commercially insured population.

The $24.7 billion savings potential reflects the introduction this year of new generic drugs in two of the most widely-used classes -- the anti-cholesterol drug simvastatin (generic Zocor) and the anti-depressant drug sertraline (generic Zoloft). In 2005, Zocor and Zoloft had sales of $3.1 and $2.6 billion, respectively.

Thus, the biggest savings available this year are in the anti-cholesterol class at $10.3 billion. Generics, including lovastatin, pravastatin and ultimately simvastatin, are potent enough to fill 85 percent of all prescriptions for an anti-cholesterol drug, based on existing prescribing patterns.

On average, only 18.8 percent of anti-cholesterol prescriptions are currently filled with a generic. However, some health plans have already achieved generic utilization in the anti-cholesterol class exceeding 75 percent, according to published reports.

"We have a tremendous opportunity to conserve precious health care dollars by increasing our use of less expensive generic drugs and still achieve the same clinical benefit," said Dr. Ed Weisbart, Express Scripts chief medical officer.

The generic fill rate goals utilized in the report are based on an evaluation of clinical efficacy and market dynamics of branded and generic medications. In 2004 and 2005, failure to take advantage of the full potential of generic drugs in the six classes resulted in missed savings opportunities of $20 and $21.3 billion, respectively.

The Express Scripts report also ranked 2005 generic drug use and savings opportunities by state, revealing significant variations across the six drug categories.

Last year, California had the biggest absolute savings potential at $1.7 billion, but, on a per capita basis, Kentucky passed up the most savings at $163 per commercially insured life. New Mexico was best at capturing generic savings, leaving only $81 per capita unclaimed.

Using 2005 data as a guide, the states with the most to gain from greater use of generic anti-cholesterol drugs this year are Delaware, Michigan, West Virginia, Maryland, and Kentucky on a per capita basis. The leaders in absolute savings potential are California, Texas, Florida, Pennsylvania and Ohio.

In 2005, New Mexico and Massachusetts had the highest overall use of generic drugs at 60 and 59 percent, respectively, while New Jersey at 41 percent and New York at 43 percent had the lowest.

In addition to New Jersey and New York, four other states had generic fill rates of less than 50 percent: Florida, Louisiana, Maryland, and Texas. Neither Hawaii nor Alaska was included in the analysis.

The savings opportunity from increased use of generic drugs has never been greater. More than $50 billion worth of branded drugs will lose patent exclusivity over the next five years. This year alone, $14.3 billion in drug sales are expected to lose patent, with generic alternatives becoming available for at least 16 branded drugs.

A generic drug costs approximately 60 percent less than a brand name drug, on average. Consumers also pay a lower co-payment for generic medications, saving $15 or more per prescription on average compared to branded medications.

Weisbart outlined four steps consumers, health plans, health professionals and policymakers can take to increase the use of generic drugs:

• Increase awareness of the wide number of generic alternatives to brand drugs.

• Always assess if a generic drug would meet the clinical need; only consider using a brand drug when there is clear evidence that the brand drug provides an important clinical value not available with todays generic medications. This strategy would free up resources to meet other pressing health care needs and help preserve the pharmacy benefit as we know it without impacting quality.

• Adopt pharmacy benefit plan designs that encourage greater use of generic drugs and share the savings with patients. For example, use programs that provide for trying a generic drug before a brand. Express Scripts recently announced that 14 million members of pharmacy plans it manages are in such programs, a five-fold increase over 2.8 million in 2001.

• Enact state laws and regulations that support the use of chemically equivalent generic alternatives to brand drugs.

Big Savings Available As Major Drugs Go Generic...
Read lessRead more

FDA Approves Generic Version Of Cholesterol Drug

Agency has approved the first generic version of Bristol-Myers Squibb's Pravachol

The Food and Drug Administration has approved the first generic version of Bristol-Myers Squibb's Pravachol, a move it touts as an important step in the agency's effort to increase the availability of lower-cost generic medications.

Pravachol (Pravastatin Sodium Tablets) is indicated for the treatment of individuals with high cholesterol levels or who are at increased risk for atherosclerosis-related cardiac and cardiovascular events, such as heart attack and stroke in which high cholesterol levels are a factor.

In 2005, Pravachol was the 22nd highest-selling brand-name drug in the United States, with sales totaling $1.3 billion.

"This approval is another example of our agency's endeavor to counter rising health care costs by approving safe and effective generic alternatives as soon as the law permits," said Dr. Scott Gottlieb, Deputy Commissioner for Medical and Scientific Affairs.

"Pravastatin is a widely-used cholesterol-lowering agent, and its generic version can bring significant savings to the millions of Americans with this disease."

Generic drug products are used to fill over 50 percent of all prescriptions and since they cost a fraction of the price of brand name drugs, the economic impact of FDA's generic drug program is significant.

FDA's Office of Generic Drugs (OGD) said it is considering several new policies that could lead to the overall reduction of review time for new generics.

These include new review formats which allow for overall risk assessments for individual applications in order to dictate the level of OGD review need for subsequent product changes. When fully implemented this has the potential to reduce supplements by 80 percent and reduce Office expenditures of time and money.

Bristol-Myers Squibb's patent for the drug expired on April 20. Pravastatin Sodium Tablets (10mg, 20mg and 40mg) are manufactured by TEVA Pharmaceuticals in Kfar Sava, Israel.

FDA Approves Generic Version Of Cholesterol Drug...
Read lessRead more

FDA Refuses to Ban Weight-Loss Drug Meridia

The Food and Drug Administration has refused to ban the weight loss drug Meridia. The agency rejected a petition filed by Public Citizen, asking that the Abbott Labs drug be banned because of concerns that it caused heart attacks and strokes in some patients.

In a letter to Public Citizen, the FDA said it believes that the drug's "overall risk-benefit profile supports it remaining available as a prescription drug for the treatment of appropriately selected obese patients."

"Once again, the FDA is siding with a large drug company, much as the agency did several years ago with Merck concerning Vioxx, when it failed to demand a black box warning on that drug," said Sidney M. Wolfe, MD, Director of Public Citizens Health Research Group.

"For a drug such as Meridia to be approved or for it to stay on the market, there must be evidence that its benefits outweigh its risks. Evidence prior to its approval and more than 50 cardiovascular deaths, many in young people, since its approval confirm that its benefits do not outweigh its risks and that it should be removed from the market despite efforts by the FDA/Abbott duo to keep the drug alive," Wolfe said.

The FDA said it was continuing to monitor the drug's safety profile.

The FDA said it couldn't conclude that the reports of heart attacks and strokes were caused by Meridia and noted that such events "are very common in patients with obesity." However, the agency said it is "plausible" that Meridia could raise the risk for some cardiac events.

But in a prepared statement Wolfe questioned whether all of the deaths caused by the drug had been reported: "A 3/21/02-4/03/02 FDA inspection report of the Abbott Laboratories plant in Abbott Park, Ill., found that '[one] death associated with Meridia was not reported and several records [involving seven other deaths] reviewed showed that the adverse drug information reported to FDA was either not accurate, not supported by source data, or was missing additional information found in the source data.'"

The FDA said it received 224 reports of nonfatal heart attacks and strokes from November 1997 through August 2003 among Meridia users. It received 54 reports of deaths, including 30 that were cardiovascular-related.

Last year FDA scientist David Graham questioned whether Meridia was effective enough to stay on the market during congressional testimony about how the agency handled safety questions surrounding Merck & Co's Vioxx, taken off the market in September.

Wolfe also questioned the drug's effectiveness, particularly when weight against its risks.

"In one of the only independent reviews of this drug by researchers from the University of Washington, published a year ago but predictably not mentioned by either the FDA or by Abbott in their responses to our petition, the authors concluded that: 'Weight loss with sibutramine was associated with modest increases in heart rate and blood pressure. There was no direct evidence that sibutramine reduces obesity-associated morbidity or mortality. Thus, we conclude that there is insufficient evidence to accurately determine the risk-benefit profile for sibutramine,'" Wolfe said.

Clinical studies have shown the drug can help people lose 5% to 10% of their body weight when used in conjunction with a program of diet and exercise.

FDA Refuses to Ban Weight-Loss Drug Meridia...
Read lessRead more

Tufts Study Finds Crestor Most Dangerous Statin

FDA Previously Strengthened Warning on Drug Label

More trouble for Crestor, the Astra-Zeneca statin that's been the target of safety complaints. Researchers from Tufts-New England Medical Center have found that Crestor has the poorest safety profile of the most commonly used anti-cholesterol drugs, the others being Lipitor, Zocor and Pravachol.

The study, published in the latest issue of Circulation, the Journal of the American Heart Association, found the most serious reactions resulted in damage to the kidney (proteinuria/nephropathy), and muscle (rhabdomyolysis), which frequently resulted in patients requiring hospitalization.

In March, the FDA issued a public health advisory outlining the identified risks and benefits of Crestor but critics argued the agency didn't go far enough.

David Graham, a safety researcher at the FDA, had singled out the drug as deserving closer safety scrutiny during congressional hearings last fall.

The advocacy group Public Citizen has also targeted Crestor and issued a blistering denunciation of the FDA's action, calling "another example of the agencys dangerous cowardice in failing to adequately protect people in this country from uniquely dangerous prescription drugs."

But the lead author of the Tufts study said it's important not to overstate the dangers of the drug.

"It is very important to note that as a family, statins are very safe drugs that have clearly been shown to reduce the risk of heart disease," said Richard H. Karas, MD, PhD, lead author of the study.

"Although rosuvastatin (Crestor) was found to be less safe than others, it does not mean patients should immediately stop taking this medication."

"In fact, the overall risks of rosuvastatin remain low, and people taking this drug should talk to their doctor before deciding whether to continue on it or stop it," Karas emphasized.

Karas and his colleagues analyzed 145 rosuvastatin-associated adverse events reported to the U.S. Food and Drug Administration over its first year of marketing and compared the rates of such events with other statins simultaneously and during their respective first year of marketing.

The review found that with either comparison, rosuvastatin (Crestor) was significantly more likely to be associated with rhabdomyolysis, proteinuria, nephropathy or kidney failure.

"This study raises concern about the safety of this drug at the range of doses currently used in common clinical practice in the general population," said Karas. "I would advise healthcare providers to consider other statins as first-line therapy, to initiate therapy in appropriate patients at lower doses, to consider combination LDL-C lowering therapy, and to closely monitor patients for adverse events if rosuvastatin (Crestor) is used."

Tufts Study Finds Crestor Most Dangerous Statin...
Read lessRead more

FDA Issues Crestor Advisory

Critics say the agency didn't go far enough

The Food and Drug Administration (FDA) has issued a public health advisory outlining the identified risks and benefits of Crestor, a cholesterol-lowering drug. But critics say the agency didn't go far enough.

The Astra-Zeneca product has been plagued by claims that it can cause rhabdomyolysis, a breakdown of muscle fibers that can lead to kidney damage. This is a well-known, rare adverse effect of all statins.

The FDA's advisory says an extensive review of the data indicates that patients taking recommended doses of Crestor have a risk similar to patients on other statin cholesterol treatments.

David Graham, a safety researcher at the FDA, had singled out the drug as deserving closer safety scrutiny during congressional hearings last fall. The advocacy group Public Citizen has also targeted Crestor and issued a blistering denunciation of the FDA's action, calling "another example of the agencys dangerous cowardice in failing to adequately protect people in this country from uniquely dangerous prescription drugs."

"Like statements from AstraZeneca, the FDAs statement is replete with false and misleading information," said Sidney M. Wolfe, MD, Director, Public Citizens Health Research Group.

"Rather than responding in a public health-positive manner to our March 2004 petition and banning this drug, the FDA has done exactly what AstraZeneca wanted with minimal labeling changes and surely has pleased one of the drug companies contributing to the $150 million in drug industry funding that the FDA is receiving this year for drug review." Wolfe said.

Besides the FDA advisory, Crestor's manufacturer Astra-Zeneca Pharmaceuticals has revised the package insert for Crestor, based on discussions with the FDA. These changes re-emphasize recommendations made in the original label about the need for physicians to consider using lower starting doses of the drug in some individuals as a means of reducing the risk of rhabdomyolysis.

"The FDA is committed to providing Americans with the latest and most comprehensive information on the medicines they use," said Dr. Steven Galson, Acting Director, Center for Drug Evaluation and Research (CDER).

Galson says the advisory "is part of an ongoing effort to notify the public of potentially significant emerging safety data so that they can make more informed choices about their medical care."

The revised labeling notes that this may be particularly important for treating Asian American patients, since clinical trial data suggest that they (along with patients on cyclosporine or patients with severe renal insufficiency) may have higher drug levels and therefore be at greater risk for muscle injury due to Crestor than the general population.

But Public Citizen said that since October 2004, when it petitioned FDA to clamp down on Crestor, there have been an additional 52 U.S. cases of life-threatening muscle damage (rhabdomyolysis) reported to the FDA and an additional 12 U.S. cases of kidney failure or impairment in people not having rhabdomyolysis reported to the agency up to the end of January of this year.

"The total of such U.S. cases reported since the drug was first marketed in September 2003 is now 117 cases of rhabdomyolysis and 41 cases of kidney failure, both higher than seen with the other currently marketed statins," Wolfe said. "Because of concerns about the safety of Crestor, several countries, including Germany, Norway and Spain, have not approved the drug."

Overall, FDA said it believes that potential benefits of statin drugs (including Crestor) when used as labeled and indicated for the treatment of elevated cholesterol (hypercholesterolemia) outweigh their potential risks and provide an important treatment option for millions of Americans at risk of heart disease.

FDA Issues Crestor Advisory...
Read lessRead more

FDA Clears New MS Treatment

The Food and Drug Administration has licensed a new biologic approach to treat patients with relapsing forms of multiple sclerosis

The Food and Drug Administration has licensed a new biologic approach to treat patients with relapsing forms of multiple sclerosis (MS) to reduce the frequency of symptom flare-ups or exacerbations of the disease. MS is a chronic, often disabling disease of the brain and spinal cord.

Natalizumab, the new product, is a monoclonal antibody bioengineered from part of a mouse antibody to closely resemble a human antibody. It is being marketed under the tradename Tysabri. The product is given intravenously once a month in a physician's office.

According to the Multiple Sclerosis Association of America, approximately 350,000 individuals have been diagnosed with MS in the U.S., with an estimated 10,000 new cases diagnosed each year. The most common form of MS at the time of initial diagnosis is a relapsing-remitting form, in which acute symptoms or worsening of neurologic function, referred to as "relapses," "attacks," or "exacerbations," occur intermittently. The symptoms can diminish or disappear for months or years between relapses.

Although the cause of MS is unknown, it is widely considered to be an autoimmune disease in which the person's immune system attacks the brain and/or spinal cord. Tysabri appears to work by binding to these immune system cells, thus preventing them from traveling to the brain where they can cause damage.

Antibodies are proteins produced by a person's immune system to fight foreign substances, such as infections. Monoclonal antibodies, such as natalizumab, can be produced in large quantities in cell culture in a laboratory setting. They can be designed to bind to proteins on the body's normal cells. By recognizing and attaching to these proteins, monoclonal antibodies can interfere with (or alter) normal or abnormal cellular responses. In this way, monoclonal antibodies may be useful in the treatment of certain diseases such as MS.

"This innovative treatment for multiple sclerosis represents a new approach to treating MS -- exciting news for patients with this serious disease," said Dr. Lester M. Crawford, Acting FDA Commissioner. "While we eagerly await long-term results from ongoing clinical trials, we have reason to believe that Tysabri will significantly reduce relapses in MS."

The FDA said approval of Tysabri is based on positive results seen in patients after one year of treatment. The agency said the product received accelerated approval because it appears to provide substantial benefit for patients with a serious disease. As part of that approval, the manufacturer has committed to continuing its trials of this product for another year.

Tysabri was evaluated for safety and efficacy in two ongoing randomized, double-blind, placebo-controlled trials in patients with relapsing forms of MS. In the first clinical trial of the product's safety and efficacy, the drug reduced the frequency of relapses by 66 percent relative to placebo.

In a second trial, patients who had been treated with Avonex (interferon beta-1a), an approved treatment for MS, but who had experienced one or more relapses while on Avonex, were randomized to receive Tysabri or placebo. Avonex was continued throughout the study for both groups. In this trial, natalizumab reduced the frequency of relapses by 54 percent relative to placebo.

The most frequently reported serious adverse reactions were infections, including pneumonia, temporary hypersensitivity reactions (such as rash, fever, low blood pressure, and chest pain), depression, and gallstones. These serious adverse reactions were uncommon.

Common adverse reactions were generally mild and included non-serious infections such as urinary tract, lower respiratory tract, GI system, and vaginal infections, headache, depression, joint pains, and menstrual disorders.

Tysabri is marketed by Biogen Idec, Inc., of Cambridge, Massachusetts, and Elan Pharmaceuticals, Inc., of Dublin, Ireland.

FDA Clears New MS Treatment...
Read lessRead more

Public Citizen Warns Against New Statin Drug Crestor

Public Citizen says the drug has a significant potential to cause kidney damage and failure

Patients should not take the newly approved cholesterol drug, rosuvastatin, which AstraZeneca will sell under the name Crestor, because it has a significant potential to cause kidney damage and failure, as well as muscle destruction, Public Citizen's Health Research Group said today.

The U.S. Food and Drug Administration (FDA) approved the drug on Aug. 13 and it is just now becoming available by prescription.

Public Citizen will issue a "Do Not Use!" warning about Crestor in the October issue of Worst Pills, Best Pills News. Although the site usually requires that users subscribe to read its articles, the full text of the warning on Crestor was posted today at no charge because of the serious danger that Crestor users may face.

Public Citizen made a formal presentation to an FDA advisory committee in July, strongly opposing the drug's approval based on its unique kidney toxicity.

The drug was approved on the condition that it be available only in five, 10 and 20 milligram strengths, with restricted distribution of a 40 milligram dose. Such restrictions, however, will not adequately protect patients, Public Citizen charged.

"It was irresponsible of the FDA to approve this drug without requiring routine urine testing for protein and blood to monitor for the early signs of kidney damage, " said Sidney Wolfe, M.D., director of Public Citizen's Health Research Group. "This drug is already showing signs that it is too dangerous for people to take, and it is only a matter of time, after 'enough' people have been injured or killed, that it will have to be pulled from the market."

In studies before its approval, seven people were struck by cases of rhabdomyolysis, an adverse reaction involving the destruction of muscle tissue that can lead to kidney failure.

Baycol, another statin, was removed from the market in the fall of 2001 after at least 31 reports of fatal rhabdomyolysis. For more than three years before it was banned, Public Citizen warned patients not to use Baycol. Even so, Baycol did not show life-threatening rhabdomyolysis in pre-approval clinical trials. Crestor is the only statin to have the reaction arise before its approval.

In addition to the risks of kidney damage, patients should avoid Crestor because it has not been shown to reduce the risk of heart attacks and strokes, which is a benefit of lower cholesterol levels. Three other statins - lovastatin, pravastatin and simvastatin - have shown such a benefit.

In the past, Public Citizen's Do Not Use! warnings have preceded safety-related withdrawals of drugs such as Baycol, Propulsid and Rezulin by months, sometimes years. The Health Research Group has listed more than 200 drugs as Do Not Use! during the past 15 years.

Public Citizen Warns Against New Statin Drug Crestor...
Read lessRead more