The agency recommends that retail pharmacies only purchase authentic Ozempic through authorized distributors of Novo Nordisk products, available at this link. Novo Nordisk is the manufacturer of Ozempic.
The FDA also urged wholesalers, retail pharmacies, healthcare practitioners, and patients to check the products that they have received and not distribute, use, or sell products labeled with lot number NAR0074 and serial number 430834149057. The FDA also warned that some counterfeit products might still be available for purchase.
As of late December, the FDA and Novo Nordisk were testing the seized products and did not have information yet about the drugs’ identity, quality, or safety.
The FDA said it is aware of five adverse events from this lot, none of which are serious and are consistent with known common adverse reactions to authentic Ozempic. Those are nausea, vomiting, diarrhea, abdominal pain, and constipation.
Complicating matters, however, is that an analysis found that the needles from the samples to also be counterfeit. “Accordingly, the sterility of the needles cannot be confirmed, which presents an increased risk of infection for patients who use the counterfeit products,” according to the FDA. “Based on analyses completed to date, other confirmed counterfeit components within the seized products are the pen label, accompanying health care professional and patient information, and carton.”
The FDA emphasized that patients should only obtain Ozempic with a valid prescription through state-licensed pharmacies and check the product before using it for any signs of counterfeiting.
The FDA also recently addressed issues about compounded versions of semaglutide, which is a glucagon-like peptide-1.
The three FDA-approved semaglutide products currently marketed are:
• Ozempic injection and Rybelsus tablets. These are approved to lower blood sugar levels in adults with type 2 diabetes mellitus (T2DM), in addition to diet and exercise. Ozempic is also approved to reduce the risk of heart attack, stroke, or death in adults with T2DM and known heart disease
• Wegovy injection is approved to help adults and children aged 12 years and older with obesity or some adults with excess weight (overweight) who also have weight-related medical problems to lose weight and keep the weight off, in addition to diet and exercise.
All three medications are available only with a prescription, and there are no approved generic versions, the FDA said.
When a drug is in shortage, licensed pharmacists—and others who meet the criteria in the Federal Food, Drug, and Cosmetic Act—might be able to prepare a compounded version of that drug. The semaglutide products have been on shortage lists throughout the past year, primarily because they have reached fad-status as weight-loss drugs.
Approximately 7,500 compounding pharmacies operate in the United States, according to the American Pharmacists Association.
“FDA has received adverse event reports after patients used compounded semaglutide,” according to an agency press release. “Patients should not use a compounded drug if an approved drug is available to treat a patient. Patients and healthcare professionals should understand that the agency does not review compounded versions of these drugs for safety, effectiveness, or quality.”
One issue is that compounders might be using salt forms of semaglutide, including semaglutide sodium and semaglutide acetate; the salt forms are different active ingredients than those used in the approved drugs, which contain the base form of semaglutide, according to the FDA.
Last spring, the FDA wrote the National Association of Boards of Pharmacy expressing concerns with the use of the salt forms in compounded products. In October, the FDA sent a follow-up letter expressing similar concerns to the National Association of Boards of Pharmacy and the Federation of State Medical Boards expressing similar concerns.
“While we understand certain drugs are in short supply and patients are having difficulty obtaining their medication, FDA urges patients to obtain prescription drugs only from state-licensed pharmacies that are located in the U.S., where FDA and state authorities can assure the quality of drug manufacturing, packaging, distribution and labeling,” the agency advised.
The content contained in this article is for informational purposes only. The content is not intended to be a substitute for professional advice. Reliance on any information provided in this article is solely at your own risk.
