The FDA has received 42 reports that mention the use of counterfeit semaglutide — known by brand names Ozempic and Wegovy
At least three people in the United States have been hospitalized after taking suspected counterfeits of semaglutide — known by brand names Ozempic and Wegovy — according to the Food and Drug Administration.
The agency’s Adverse Event Reporting System has received 42 reports that mention the use of counterfeit semaglutide around the world, 28 of which are in the U.S. and classified as "serious" with outcomes that also include deaths, CBS News reports.
A fraction of those reports specifically name Ozempic, the FDA-approved prescription medication to treat type 2 diabetes. Those reports, including the three U.S. hospitalizations, were all reportedly submitted by Novo Nordisk, manufacturer of Ozempic and Wegovy.
Ozempic has become increasingly popular over the past year as many — including celebrities — have jumped on the trend of using it for weight loss. The drug is in high demand because of its effectiveness — but with the average retail cost without insurance ranging from $1,205 to $1,368 — a counterfeit market has emerged.
Jeremy Kahn, a spokesperson for the FDA, told CBS that the agency 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,” Kahn said in a statement. “The FDA remains vigilant in protecting the U.S. drug supply from these threats."
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Reports in the U.S. come just weeks after several people in Austria were also hospitalized after taking what is suspected to be fake Ozempic.
At the time, the Austrian Federal Office for Safety in Healthcare, BASG, issued a warning about the circulation of counterfeit Ozempic. The counterfeit version of the drug had been found in “several patients," causing "serious side effects" including low blood sugar and seizures.
They also reminded people that the only legal way to obtain Ozempic is by “prescription and via public pharmacies and physicians in charge of in-house pharmacies.”
Austrian officials have stated that the rise in Ozempic use has caused medication shortages for people with type 2 diabetes. In turn, this has spurred criminal organizations to exploit and “place counterfeits of Ozempic on the market.”
“The BASG has received initial reports that several patients had to be treated in hospital after using suspected counterfeit Ozempic,” they added. They also explained that the patients suffered from side effects such as hypoglycemia and seizures, both of which indicate that the counterfeit falsely had insulin instead of semaglutide.
“According to the current state of investigation, stocks of the affected batch may still be in circulation or may have been obtained by other physicians via this illegal channel,” the Austrian health safety regulator continued. They also advised patients “who have obtained Ozempic pre-filled pens directly from physicians not in charge of in-house pharmacies” to “contact them immediately.”
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