Counterfeit Ozempic found in US drug supply, FDA warns

(NEW YORK) — As Ozempic and other drugs used for weight loss continue to soar in popularity, the U.S. Food and Drug Administration (FDA) has issued a new warning for consumers.

On Thursday, the FDA announced it had seized “thousands of units” of counterfeit Ozempic from the U.S. drug supply.

The agency warned consumers, as well as wholesalers, retail pharmacies and health care workers, to check Ozempic products, noting, “Some counterfeit products may still be available for purchase.”

Ozempic, made by Novo Nordisk, is approved by the FDA to treat Type 2 diabetes, but some doctors prescribe the medication “off-label” for weight loss. Ozempic is an injectable medication that is typically prescribed to be taken once per week.

The active ingredient in Ozempic is semaglutide, a medication that also was initially approved for Type 2 diabetes but which the FDA has since approved for use in weight management under the brand name Wegovy. Like Ozempic, Wegovy is also manufactured by Novo Nordisk.

In its warning, the FDA said consumers and healthcare workers should not “distribute, use, or sell” one-milligram injectable Ozempic products with the lot number NAR0074 and serial number 430834149057.

In addition, the FDA said that needles on the affected products are also counterfeit.

“Accordingly, the sterility of the needles cannot be confirmed, which presents an increased risk of infection for patients who use the counterfeit products,” the agency said. “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.”

According to the FDA, there have so far been five “adverse events” from the affected products. The agency said none of events are “serious” and noted the reported complications have been consistent with the standard side effects of drugs used for weight loss, including Ozempic, which include nausea, vomiting, diarrhea, abdominal pain and constipation.

The agency said it is continuing the investigation and is working with Novo Nordisk to “identify, investigate, and remove further suspected counterfeit semaglutide injectable products found in the U.S.”

Consumers and healthcare workers are asked to report adverse events or side effects from Ozempic use via the FDA’s website.

Consumers can also report suspected counterfeit products to their state’s FDA consumer complaint coordinator or directly to the FDA via their website. You can also call Novo Nordisk about Ozempic concerns at 1-800-727-6500.

The FDA’s warning about counterfeit Ozempic comes nearly seven months after the agency warned consumers that off-brand forms of drugs being used for weight loss could be unsafe.

The agency issued the warning in June as many people have reported turning to compounding pharmacies to get cheaper doses of semaglutide. Without insurance coverage, the cost of medications like Ozempic can run more than $1,000 a month.

Compound versions of drugs are made for individual patients using raw ingredients. The FDA said at the time it had received reports of adverse events after people administered semaglutide that was made by a compounding pharmacy. The FDA did not specify the number of reports, nor what the adverse events were.

“Patients should not use a compounded drug if an approved drug is available to treat a patient. Patients and health care professionals should understand that the agency does not review compounded versions of these drugs for safety, effectiveness, or quality,” the FDA said in a new safety warning this week.

 

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