FDA says fake Ozempic carries risk of infection

The Food and Drug Administration is sounding the warning bell on counterfeit versions of the weight loss medication Ozempic, saying fakes cause possible infection risks.

The agency said it has seized thousands of units of the product, which has crept its way into the legitimate U.S. drug supply chain. 

The FDA advises wholesalers, retail pharmacies, healthcare practitioners and patients to check the product they have received and not distribute, use or sell products labeled with lot number NAR0074 and serial number 430834149057, as some counterfeit products may still be available for purchase.

WHAT’S THE IMPACT?

FDA and Novo Nordisk, Ozempic’s manufacturer, are testing the seized products and do not yet have information about the drugs’ identity, quality or safety. 

The analysis also found the needles from the samples are counterfeit. Accordingly, the sterility of the needles can’t be confirmed, which presents an increased risk of infection for patients who use the counterfeit products, the FDA said. Other confirmed counterfeit components within the seized products are the pen label, as well as accompanying healthcare professional and patient information.

The FDA is aware of five adverse events from this batch, none of which are serious and are consistent with known common adverse reactions to authentic Ozempic, which include nausea, vomiting, diarrhea, abdominal pain and constipation.

The agency is recommending retail pharmacies only purchase authentic Ozempic through authorized distributors of Novo Nordisk and review the photographs and information to confirm the legitimacy of their shipments. Patients should only obtain Ozempic with a valid prescription through state-licensed pharmacies and check the product before using for any signs of counterfeiting.

Currently, the investigation is ongoing. The FDA agency is working with Novo Nordisk to identify, investigate and remove further suspected counterfeit semaglutide injectable products found in the U.S.

Healthcare professionals and consumers should report adverse events or side effects related to the use of the product to FDA’s MedWatch Safety Information and Adverse Event Reporting Program, the agency said.

THE LARGER TREND

GLP-1 medications, originally designed for diabetes management, have skyrocketed in popularity over the past year as an effective drug for weight loss and obesity. Ozempic is one such GLP-1 drug.

While 81% of human resource decision-makers feel their employees would be interested in GLP-1 weight-loss medications, only 25% cover GLP-1s currently – but that figure is expected to double this year, according to a new survey from Accolade.

Three-quarters of HR decision-makers are aware of GLP-1 medications and acknowledge them as beneficial for controlling blood sugar, boosting weight loss, improving blood pressure and lowering the risk of heart disease, among other uses, according to the survey.

Buzz around GLP-1 weight-loss drugs is growing, but if patient demand continues to grow and Medicare expanded its coverage in response, it could cost the federal program between $13.6 and $26.8 billion annually, a recent KFF analysis found.

Twitter: @JELagasse
Email the writer: Jeff.Lagasse@himssmedia.com