FDA Drug Approvals

If you recently got a tattoo, a piercing, a laser treatment, or are thinking about getting one, you might want to consider one of a large yellow “Danger” sign.

The Food and Drug Administration (FDA) is warning consumers that the numbing creams you see online for those procedures often have too much  lidocaine, which might make your skin crawl in a whole different way.

The agency’s concern about lidocaine is that the cream’s concentrations are higher than what is permitted for over-the-counter, topical pain relief products. 

“When these products that contain high concentrations of lidocaine intended to be used before or during certain cosmetic procedures are applied in ways that could lead to increased absorption of the drug product through the skin, it may lead to serious injury such as irregular heartbeat, seizures and breathing difficulties," the agency said. "These products may also interact with medications or dietary supplements a consumer is taking."

The FDA isn’t playing around with this situation, either. In letters to six different companies -- such as this one to the manufacturer of NumbSkin -- the agency told these manufacturers that these products are in violation of federal law.

How to stay comfortably numb

The agency says that anyone who needs a “numbing product” would be wise to:

• Check the label: Never use anything over-the-counter with more than 4% lidocaine.

• Less is more: Don't slather it on huge areas of your skin, especially if your skin's already irritated.

• No plastic wrap: Don't cover the area with plastic wrap or anything that traps the cream.

And if you have any bad side effects from these creams, be sure to tell the FDA ASAP through its MedWatch Adverse Event Reporting program so the agency can take action to protect the public from any unsafe products.

The U.S. Food and Drug Administration (FDA) thinks seven companies have gone too far in claiming that their dietary supplements can cure, treat, mitigate or prevent cardiovascular disease or related conditions, such as atherosclerosis, stroke or heart failure.

The FDA is making an all-out plea to consumers to stop using these – or similar products – because they haven’t been cleared by the agency as safe or effective for their intended use and may be harmful.

The warning letters were issued to: Essential Elements; Calroy Health Sciences; Iwi; BergaMet North America; Healthy Trends Worldwide (Golden After 50); Chambers' Apothecary; and Anabolic Laboratories. Those manufacturers market a variety of products tied to cardiovascular disease, et al, such as CoEnzyme Q10 and Cholesterol Command.

Dear sir, please stop what you’re doing… now

When ConsumerAffairs reviewed the letter sent to the various companies, it was clear that the FDA was nowhere near happy about how far those supplement producers had gone to convince the unaware consumer that their products were the end-all and be-all.

For example, in its letter to Healthy Trends Worldwide, the maker of Golden After 50 products, the company’s pitch of “That’s why we combined five science-backed ingredients from nature that address multiple factors to help regulate blood pressure” was labeled a false claim.

As was pushing its products’ agenda on YouTube videos where a spokesperson said that ingredients of its BP-5 formula “can lower your high blood pressure naturally and fast.”

“Your BPS-5 product is not generally recognized as safe and effective for the above referenced uses and, therefore, this product is a “new drug” … [adding] “new drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA. FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective," the letter stated.

What’s so bad about dietary supplements, anyway?

The FDA isn’t criticizing dietary supplements in general. It feels that some can help a person improve their health or help meet the daily requirements of essential nutrients. What it’s unhappy about is that companies are promise-bombing the internet with unfounded claims.

“Given that cardiovascular disease is the leading cause of death in the U.S., it’s important that the FDA protect the public from products and companies that make unlawful claims to treat it,” said Cara Welch, director of the Office of Dietary Supplement Programs in the FDA’s Center for Food Safety and Applied Nutrition. 

And, yes, dietary supplements have to pass the approval of the agency just like a doctor-prescribed drug does.

Fortunately, the seven companies receiving those letters haven’t been served an order to shut down, but rather a request to address the agency’s concerns – what the proper dosage might be, how they could interact with FDA-approved drugs or other substances, or whether they have dangerous side effects or other safety concerns.

“Dietary supplements that claim to cure, treat, mitigate or prevent cardiovascular disease and related conditions could potentially harm consumers who use these products instead of seeking safe and effective FDA-approved treatments from qualified health care providers. We encourage consumers to remain vigilant when shopping online or in stores to avoid purchasing products that could put their health at risk,” Welch said.

For a complete list of FAQs and questions to ask physicians and pharmacists regarding dietary supplements, the FDA offers a consumer guide here.

Earlier this week, the U.S. Food and Drug Administration (FDA) approved a new oral treatment for consumers who suffer from acute migraines.

The drug, named Ubrelvy, is manufactured by Allergan and meant to be taken after symptoms of a migraine have already begun to set in. The FDA said the drug was proven to be more effective than placebos in two randomized, double-blind trials. 

“The FDA is pleased to approve a novel treatment for patients suffering from migraine and will continue to work with stakeholders to promote the development of new safe and effective migraine therapies,” said FDA director Dr. Billy Dunn.

Many participants who took Ubrelvy in the drug trials reported feeling no pain or other associated migraine symptoms after two hours. Regulators said the results are promising for treating a serious health condition that affects millions of people.

“Migraine is an often disabling condition that affects an estimated 37 million people in the U.S. Ubrevly represents an important new option for the acute treatment of migraine in adults, as it is the first drug in its class approved for this indication,” said Dunn. 

The Food and Drug Administration (FDA) has approved a new generic version of the blood pressure drug valsartan, which is also sold under the trade name Diovan. Valsartan is a widely used angiotensin II receptor blocker (ARB) that doctors prescribe for high blood pressure and heart failure.

The approval was placed on the FDA fast track after the agency confirmed the presence of an impurity in several lots of the medicine last year. Researchers detected a trace amount of an unexpected impurity -- N-nitrosodimethylamine (NDMA). NDMA has been classified as a probable human carcinogen by the International Agency for Research on Cancer (IARC).

The discovery led to major recalls of existing forms of valsartan, which in turn led to shortages of the drug.

“To address the public health consequences of these shortages, we've prioritized the review of generic applications for these valsartan products,” said FDA Commissioner Scott Gottlieb. “When faced with a drug shortage situation, the FDA employs a number of strategies to help mitigate the effects of the shortage on patients. As part of that work, we look at where we may be able to prioritize review of pending generic applications of the medicine in shortage, or similar products.”

Gottlieb said he is hopeful the approval of the new generic will quickly alleviate the valsartan shortage. Meanwhile, he says the FDA will step up its efforts to keep impurities out of approved prescription drugs.

Suspected human carcinogen

Valsartan began disappearing from pharmacies in the middle of last year after a Chinese company reported the presence of NDEA in several batches of its valsartan API. It was of special concern since NDEA is a suspected human carcinogen.

The FDA began its tests after the Chinese report and resulting recalls. The FDA probe, completed in September, not only found the impurity in the Chinese company's product, but also in Torrent Pharmaceutical’s valsartan 160mg (lot BV47D001) and 320mg (lots BV48D001 and BV48D002) tablets.

The discovery of a potential carcinogen in a prescription drug may well have been a wakeup call for the agency, It says it has conducted a major investigation to address the presence of nitrosamine impurities in certain generic ARB products.

The FDA says it has also worked with companies to move quickly to remove any products with unacceptable impurities from the U.S. market.

Mrs. Thomas took her prescription for her heart medication to the pharmacy to have it filled. “I don’t want one of those generic drugs either,” she stated. “I want the real thing.” So, are brand name drugs really better than generic version?

According to recent information published in Consumer Reports, the answer is an emphatic no. To win approval from the Food and Drug Administration (FDA), the manufacturer of the generic medication must show that the drug has the same active ingredient and that it is identical in strength, dosage form, route of administration and labeling as the brand name drug.

The company must also demonstrate that individuals absorb and excrete the medication at the same rate. Says a pharmaceutical scientist who worked for decades at the FDA, “People may think that brand name products are better because they’re more expensive, but the body doesn’t know whether the drug came from a brand name or a generic company.”

When a medication goes off patient, other pharmaceutical manufacturers are free to create generic versions of that drug. The consumer can save considerable money by switching to the generic form of that drug. But the price of the drug does not go down immediately after the generic is released to the market.

Let’s take a mythical medication, Fat-no-more, used for weight loss, as an example. The brand’s retail price for a month’s worth of Fat-no-more is $220. Then it goes generic. After one year, the generic price is about half: $110. After 2 years on the market, it goes to $48. After 3 years, the price is $12.

Why does it take so long for the price to go down? When a drug is about to go off patent, manufacturers file lawsuits to challenge the patent. The company that wins obtains a 6-month period to sell that generic exclusively. When that period is over, other generic houses can produce that drug, forcing the prices even lower. Today, 8 out of 10 prescriptions filled in the US are for generic drugs, says the FDA. Cost is a big factor because generics can be as much as 85% cheaper than their brand counterparts.

Costs soaring

The cost of generic drugs is soaring, however.

Relatively cheap as they are compared with brand name products, the price gap between brand name drugs and generics is beginning to narrow – and it is not because proprietary drugs are getting cheaper. A 2014 article in the New England Journal of Medicine revealed that certain older drugs, many of which are generic and not protected by patents or market exclusivity, are now also extremely expensive.

Examples:

• Captopril, used for hypertension and heart failure, increased in price by more than 2,800% between November 2012 and November 2013, from 1.4 cents to 39.9 cents per tablet.
• Doxycycline, a broad-spectrum antibiotic that has been in existence since 1967, zoomed in price from 6.3 cents to $3.36 per pill.
• Clomipramine, a long-established antidepressant, has jumped in price from 22 cents to $8.32 per pill.
• Digoxin, used for atrial fibrillation (irregular heartbeat) and heart failure by millions of Americans, saw a price increase of 637% between 2002 and 2013.
• Some generic versions of codeine formulations for migraine, thyroid medicines, as well as the generic steroid prednisolone, have all more than doubled in price since last year, according to industry analyst EvaluatePharma. 

Yet, low-cost generics have saved the health care industry $209 billion in 2012, $239 billion in 2013 and almost $1.5 trillion over the past decade, according to the most recent data.

Sadly, prices have spiked for certain medications because of shortages of raw materials, supply disruptions or other factors that have led some manufacturers to stop producing those medications, resulting in a near monopoly. The number of manufacturers of digoxin, for example, has fallen from 8 to 3.

As Aaron Kesselheim, MD, assistant professor of pharmaceutical economics at Harvard Medical School, stated, “Studies show it is not until you have 4 or 5 companies manufacturing the same generic will the prices really drop.” Therefore, ask your doctor to switch your medications to another drug in that class if you are spending more money than you would like.

Mrs. Thomas’ pharmacist explained the generic process to her and she agreed that perhaps the generic form of her pricy heart medication was as good as the “real thing” and she agreed to switch to the generic. She was pleased at the money she saved, as well as the confidence she gained from her pharmacist’s counseling.

The FDA has moved levonorgestrel – the contraceptive drug first sold as “Plan B One-Step” – one step closer to full over-the-counter status, by removing previous legal restrictions limiting the purchase of generic versions to buyers age 17 or older unless the buyers had a prescription.

Plan B's previous legal status was that official name-brand Plan B, produced by Teva, was available to all ages without a prescription, but the cheaper generic version was prescription-only to those age 16 and younger. The FDA's official reasoning for this restriction was that the generic version still needed to be tested on teenagers (rather than protecting Teva from low-priced generic competition).

NPR's health blog noted on March 2 that “the FDA now says the generic versions of the product must still say on their labels that they are intended for 'women 17 years of age or older,' but they may be sold directly from retail shelves without a requirement to produce proof of age.”

The Reproductive Health Technologies Project praised the FDA decision in a press release (.pdf) which noted that “in the very near future, people seeking generic emergency contraception, which tends to cost $7 less on average than the brand name product, will be able to get it directly off the shelf instead of from a pharmacist. Moving generic products to the shelf will also hopefully result in market competition that will drive down the price of EC overall.”

The FDA decision was made in compliance with a circa-2013 federal court order (also in .pdf form) requiring all “levonorgestrel-based emergency contraceptives [be] available without a prescription and without point-of-sale or age restrictions.”

The first generic versions of Cymbalta (duloxetine delayed-release capsules), a prescription medicine used to treat depression and other conditions, has been green-lighted by the federal government.

The U.S. Food and Drug Administration (FDA) has given approval to

Aurobindo Pharma Ltd., Dr. Reddy’s Laboratories Ltd., Lupin Ltd., Sun Pharma Global FZE, Teva Pharmaceuticals USA, and Torrent Pharmaceuticals Ltd. to market the drug in various strengths.

“Health care professionals and consumers can be assured that these FDA-approved generic drugs have met our rigorous standards,” said Kathleen Uhl, M.D., acting director of the Office of Generic Drugs in the FDA’s Center for Drug Evaluation and Research. “Generic drugs offer greater access to health care for many people.”

Boxed warning

Duloxetine and other antidepressant drugs have a boxed warning describing the increased risk of suicidal thinking and behavior during initial treatment in children, adolescents and young adults ages 18 to 24. The warning also says data do not show this increased risk in those older than 24 years and that patients ages 65 and older who take antidepressants have a decreased risk of suicidal thinking and behavior.

The warning says depression and other serious psychiatric disorders themselves are the most important causes of suicide and that close monitoring of patients starting these medications is necessary. Duloxetine must be dispensed with a patient medication guide that describes important information about the drug’s uses and risks.

Common adverse reactions reported by people taking Cymbalta include nausea, dry mouth, drowsiness, fatigue, decreased appetite, increased sweating, and dizziness.

Generic prescription drugs approved by the FDA have the same high quality and strength as brand-name drugs. Generic prescription drug manufacturing and packaging sites must pass the same quality standards as those of brand-name drugs.

Depression is characterized by symptoms that interfere with a person's ability to work, sleep, study, eat, and enjoy once-pleasurable activities. Episodes often recur throughout a person's lifetime.

Signs and symptoms of depression include: depressed mood, loss of interest in usual activities, significant change in weight or appetite, insomnia or excessive sleeping (hypersomnia), restlessness/pacing (psychomotor agitation), increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration and suicide attempts or thoughts of suicide.

Patients with previously untreated chronic lymphocytic leukemia (CLL) have a new treatment option.

The U.S. Food and Drug Administration (FDA) has approved Gazyva (obinutuzumab) for use in combination with chlorambucil.

CLL is a blood and bone marrow disease that usually gets worse slowly. According to the National Cancer Institute, 15,680 people in the U.S. will be diagnosed and 4,580 will die from the disease this year.

The approval “represents an important new addition to the treatments for patients with CLL,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “This approval reflects the promise of the Breakthrough Therapy Designation program, allowing us to work collaboratively with companies to expedite the development, review and availability of important new drugs.”

How it works

Gazyva works by helping certain cells in the immune system attack cancer cells. Gazyva is intended to be used with chlorambucil, another drug used to treat patients with CLL.

It's the first drug with breakthrough therapy designation to receive FDA approval. This designation was requested by the sponsor and granted soon after the biologic license application to support marketing approval was submitted to the FDA.

The FDA can designate a drug a breakthrough therapy at the request of the sponsor if preliminary clinical evidence indicates the drug may offer a substantial improvement over available therapies for patients with serious or life-threatening diseases.

Gazyva was granted priority review because it demonstrated the potential to be a significant improvement in safety or effectiveness in the treatment of a serious condition. And the FDA granted Gazyva orphan product designation because it is intended to treat a rare disease.

Side effects

The most common side effects observed in participants receiving Gazyva in combination with chlorambucil were infusion-related reactions, a decrease in infection-fighting white blood cells (neutropenia), a low level of platelets in the blood (thrombocytopenia), low red blood cells (anemia), pain in the muscles and bones (musculoskeletal pain), and fever (pyrexia).

Gazyva is being approved with a boxed warning regarding Hepatitis B virus reactivation and a rare disorder that damages the material that covers and protects nerves in the white matter of the brain (progressive multifocal leukoencephalopathy).

These are known risks with other monoclonal antibodies in this class and rare cases were identified in participants on other trials of Gazyva.

Gazyva is marketed by South San Francisco-based Genentech.

There's a new product on the market for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and or emphysema.

Breo Ellipta (fluticasone furoate and vilanterol inhalation powder), which has been okayed by the U.S. Food and Drug Administration (FDA), is also approved to reduce exacerbations of COPD in patients with a history of exacerbations.

Symptoms of COPD, a serious lung disease that worsens over time, can include chest tightness, chronic cough and excessive phlegm. Cigarette smoking is the leading cause of COPD which, according to the National Heart, Lung, and Blood Institute, is the third leading cause of death in the United States.

Breo Ellipta, a combination of fluticasone furoate, an inhaled corticosteroid, and vilanterol, a long-acting beta2-adrenergic agonist (LABA), works by decreasing inflammation in the lungs and helping the muscles around the airways of the lungs stay relaxed to increase airflow and reduce exacerbations in patients with COPD.

A serious problem

“COPD is a serious disease that makes breathing difficult,” said Curtis Rosebraugh, M.D., M.P.H., director, Office of Drug Evaluation II, Center for Drug Evaluation and Research, FDA. “The availability of new long-term maintenance medications provides additional treatment options for the millions of Americans who suffer with COPD.”

The safety and efficacy of Breo Ellipta were evaluated in 7,700 patients with a clinical diagnosis of COPD. Those treated showed improved lung function and reduced exacerbations compared with those who used a placebo.

Asthma warning

The drug carries a boxed warning that LABAs increase the risk of asthma-related death. The safety and efficacy of Breo Ellipta in patients with asthma have not been established, and it is not approved for the treatment of asthma.

Breo Ellipta carries a patient medication guide that includes instructions for use and information about the potential risks of taking the drug. It should not be used as a rescue therapy to treat sudden breathing problems (acute bronchospasm) and is not recommended for people younger than 18 years.

Serious side effects include increased risks of pneumonia and bone fractures. Among the most common side effects are inflammation of the nasal passage (nasopharyngitis), upper respiratory tract infection, headache and oral candidiasis (thrush).

Breo Ellipta was developed by GlaxoSmithKline in collaboration with Theravance.