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FDA investigating experiences of hospitalizations after pretend Ozempic

Not less than three People have been reported hospitalized after utilizing suspected counterfeits of semaglutide medication, which embody Novo Nordisk’s diabetes medicine Ozempic, in accordance with information launched by the Meals and Drug Administration.

Ozempic and Wegovy, one other semaglutide medicine from Novo Nordisk, have been in brief provide for months amid booming gross sales for his or her use in weight reduction.

The hospitalizations are amongst 42 experiences to the FDA’s Adversarial Occasion Reporting System that point out use of counterfeit semaglutide from all over the world. The company final up to date its database on the finish of final month to incorporate experiences tallied via the top of September.

Of the experiences, 28 are categorised as “serious” with outcomes that additionally embody deaths.

Solely a portion of these particularly point out Ozempic, together with one of many three U.S. hospitalizations. All have been submitted to the FDA by Novo Nordisk, citing experiences to the corporate by both shoppers or well being care suppliers.

The information don’t show whether or not the counterfeits induced the complaints or might need been incidental to the report.

An FDA spokesperson mentioned the company has “no new information to share regarding reports of adverse events” linked to semaglutide counterfeits.

“The FDA will investigate any report of suspect counterfeit drugs to determine the public health risks and the appropriate regulatory response. The FDA remains vigilant in protecting the U.S. drug supply from these threats,” Jeremy Kahn, the spokesperson, mentioned in an e mail.

The experiences come as authorities all over the world say they’ve been battling a wave of those counterfeit medication.

Late final month, the FDA’s British counterpart — the Medicines and Well being Merchandise Regulatory Company — mentioned it had seized lots of of “potentially fake Ozempic pens since January 2023.”

The company mentioned it had additionally acquired experiences of “a very small number who have been hospitalized” after utilizing the counterfeits.

The FDA has additionally been investigating schemes trafficking counterfeit pens into U.S. pharmacies, in accordance with an trade commerce group’s warning, beforehand reported by CBS Information.

What counts as a counterfeit?

In June, Novo Nordisk mentioned it was working with the FDA after a retail pharmacy within the U.S. offered an Ozempic pen that turned out to be counterfeit.

That medicine got here packaged in a pretend label and carton that might be mistaken for an genuine Ozempic pen from Novo Nordisk, although the drugmaker mentioned there have been some telltale variations that would assist sufferers work out that that they had purchased a counterfeit.

“In close collaboration with FDA, we have taken measures to create awareness of the potential for counterfeit products. We have developed a company press statement that is posted on our U.S. corporate website and includes a guide for identifying counterfeits,” a Novo Nordisk spokesperson mentioned in an e mail.

Nonetheless, it isn’t clear if all of Novo Nordisk’s experiences to the FDA’s adversarial occasion system embody knockoffs designed to dupe individuals into considering they have been shopping for genuine Ozempic.

One entry — tagged as “product label counterfeit” — references a 2020 letter from British docs who had handled a affected person who’d bought a product known as solely “skinny pen plus” on-line.

The FDA has additionally voiced considerations over semaglutide alternate options, a few of that are manufactured by drug compounders like pharmacies. Whereas compounders are allowed to promote unapproved semaglutide to People throughout the scarcity, these aren’t topic to the identical stage of FDA oversight as Ozempic and Wegovy.

“FDA has received an increased number of adverse event reports and complaints concerning these compounded drug products,” the company wrote in a letter final month to pharmacy boards.

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