FDA is investigating deaths and hospitalizations caused by fake Ozempic: reports

The Food and Drug Administration is investigating several hospitalizations and deaths potentially linked to counterfeit semaglutide drugs, such as Ozempic, according to multiple reports.

At least three Americans have been hospitalized after injecting themselves with suspected counterfeit products, CBS News reported.

The hospitalizations being investigated are allegedly among the 42 cases reported to the FDA’s Adverse Event Reporting System that cite the use of counterfeit semaglutide — in which its game-changing ingredient is being swapped with a synthetic version of insulin.

However, cases of adverse effects sent to FAERS have not necessarily been medically confirmed and only some specifically mentioned Ozempic, including one of the three hospitalizations being investigated.


Authentic Ozempic Pen, top, and Fake Ozempic Pen, bottom
The Food and Drug Administration is investigating several hospitalizations and deaths potentially linked to counterfeit semaglutide drugs, such as Ozempic, according to multiple reports.

More than half of the cases reported are classified as “serious,” which may include deaths.

Two women allegedly died after suffering from blood clots caused by the fake meds, the Daily Mail reported.

Symptoms suffered by duped patients included seizure, skin discoloration, bruising and liver disorder, according to the British tab.

All the cases were submitted to the FDA by Novo Nordisk, the manufacturer of Ozempic.

“In close collaboration with the FDA, we have taken measures to create awareness of the potential for counterfeit products,” a representative from Novo Nordisk told The Post. “We have provided communications to a number of stakeholders, including wholesalers and pharmacists, to ensure they are aware of the situation and also able to identify a potential counterfeit semaglutide injectable product.”


Ozempic pens
Novo Nordisk warned consumers earlier this summer that counterfeit versions of the drug, which reportedly replaced semaglutide with insulin glargine, were purchased in retail pharmacies around the country.
REUTERS

Bogus versions of the diabetes drug have been found for sale on Facebook groups and, even more worryingly, have also made their way onto pharmacy store shelves.

Novo Nordisk warned consumers earlier this summer that counterfeit versions of the drug were purchased in some retail pharmacies around the country.

An FDA spokesperson has assured that all reports are being investigated and an “appropriate regulatory response” will be made. “The FDA remains vigilant in protecting the US drug supply from these threats,” the agency told The Post in a statement.

Ozempic, a semaglutide designed to improve the quality of life for diabetics, has spawned a weight loss craze across the US as patients — almost accidentally — found they were shedding pounds at rapid rates after being put on the drug. Now, non-diabetics are clamoring for the accidental diet pill, leading to shortages, reports of dangerous side effects and fraud.