FDA Drug Approvals

Johnson & Johnson has announced that the U.S. Food and Drug Administration has approved Spravato (esketamine) CIII nasal spray as the first and only monotherapy for adults with major depressive disorder who have not responded adequately to at least two oral antidepressants. 

The company hailed the approval as “a significant advancement in the treatment of MDD,” a condition affecting approximately 21 million adults in the United States.

Major depressive disorder is one of the most prevalent psychiatric disorders, and about one-third of patients do not respond to traditional oral antidepressants, severely impacting the quality of life and contributing to the high economic burden associated with treatment-resistant depression.

Image below via Johnson & Johnson

Complicated treatment

"Treatment-resistant depression can be very complicated, especially for patients who do not respond to oral antidepressants or cannot tolerate them,” said Bill Martin, head of Neuroscience at Johnson & Johnson Innovative Medicine.  

“Spravato is now available as a standalone treatment, meaning patients may experience improvements in depressive symptoms as early as 24 hours and at 28 days – without the need for daily oral antidepressants."

The FDA's decision followed a priority review and was based on positive outcomes from a randomized, double-blind, placebo-controlled study.

Johnson & Johnson said the study demonstrated that Spravato significantly improved depressive symptoms compared to placebo, with 22.5% of patients achieving remission at week four, compared to 7.6% in the placebo group. The safety profile of SPRAVATO® was consistent with previous data, with no new safety concerns identified.

The new drug is available only through a restricted program known as the Spravato Risk Evaluation and Mitigation Strategy Program. 

Zepbound is Eli Lilly’s weight loss drug. Now, it is also a drug to treat obstructive sleep apnea (OSA).

The U.S. Food and Drug Administration has approved Zepbound (tirzepatide) as the first drug treatment for adults with moderate to severe OSA who also have obesity. The FDA said the approval marks a significant advancement in the management of a condition that affects millions of individuals, particularly those struggling with obesity.

Dr. Sally Seymour, director of the Division of Pulmonology, Allergy, and Critical Care in the FDA’s Center for Drug Evaluation and Research, said the approval “is a major step forward for patients with obstructive sleep apnea.”

Obstructive sleep apnea is characterized by repeated interruptions in breathing during sleep due to the blockage of the upper airway. While continuous positive airway pressure (CPAP) devices have been the standard treatment, many patients find them uncomfortable or difficult to use consistently. 

A new approach to an old problem

The FDA said Zepbound offers a new pharmacological approach by activating receptors of hormones secreted from the intestine, specifically glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP), to reduce appetite and food intake, thereby promoting weight loss and improving OSA symptoms.

The FDA said its approval is based on the results of two pivotal randomized, double-blind, placebo-controlled studies involving 469 adults without type 2 diabetes. These studies demonstrated that participants receiving Zepbound experienced a significant reduction in the apnea-hypopnea index (AHI), a key measure of OSA severity, compared to those receiving a placebo. 

The studies also showed that a greater proportion of participants treated with Zepbound achieved remission or mild OSA, alongside significant weight loss.

Potential side effects

The FDA cautions that Zepbound is not without potential side effects. Common adverse reactions include gastrointestinal issues such as nausea, diarrhea, and abdominal discomfort, as well as injection site reactions and fatigue. 

More serious concerns include the risk of thyroid C-cell tumors, pancreatitis, gallbladder problems, and hypoglycemia, particularly when used with insulin or insulin-secreting medications. Consequently, Zepbound is contraindicated in patients with a personal or family history of medullary thyroid cancer or Multiple Endocrine Neoplasia syndrome type 2.

The FDA said patients considering Zepbound should engage in thorough discussions with their healthcare providers to weigh the benefits against potential risks, especially if they have pre-existing conditions such as kidney disease, diabetic retinopathy, or a history of depression or suicidal thoughts. 

Buy-herbal.com has issued a recall of all lots within current expiration dates of Nhan Sam Tuyet Lien Truy Phong Hoan capsules. A Food and Drug Administration analysis has found these products to contain undeclared furosemide, dexamethasone and chlorpheniramine. 

Furosemide was found at 5.24 mg/g or 1.84 mg/capsule. Dexamethasone was found at 2.22 mg/g or 0.780 mg/capsule. Chlorpheniramine was found at 4.38 mg/g or 1.54 mg/capsule. 

Products containing these drugs cannot be marketed as dietary supplements. The FDA said Nhan Sam Tuyet Lien Truy Phong Hoan Capsules is an unapproved drug for which safety and efficacy have not been established and therefore, subject to recall.

What to do

Buy-herbal.com is notifying its customers via email who have bought the product on buy-herbal.com to return for a refund of the recalled product.

Consumers who have Nhan Sam Tuyet Lien Truy Phong Hoan subject to recall should stop using the product and contact info@buy-herbal.com for return and refund. Please ship the recalled products to 136-61 41st Ave, Box # 248, Flushing, NY 11355 and contact info@buy-herbal.com for refunds.

Consumers with questions regarding this recall can email info@buy-herbal.com or call 917 495 6088 on Monday through Friday from 10 am till 6 pm Eastern Time. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Customers can contact info@buy-herbal.com for return and refunds.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

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.