Amid high demand and short supply of the weight-loss drug semaglutide, some patients have turned to counterfeit versions. Following several reports of patient harm associated with counterfeit semaglutide, FDA has opened an investigation into the cases and said that it is "vigilant in protecting the U.S. drug supply from these threats."
Currently, the United States is facing a shortage of weight-loss drugs, including Novo Nordisk's semaglutide, even as manufacturers make efforts to boost production.
In July, there were reports of some companies offering "generic" or compounded formulations of semaglutide amid supply shortages. According to endocrinologists and obesity medicine specialists, suppliers cannot ensure the safety and quality of these "bootleg" versions of the drug, making them potentially dangerous for patient use.
Compound pharmacies "are probably using the same active pharmacological part [semaglutide], but when you combine things and you add different excipients, the effectiveness—if you don't measure that in a randomized controlled trial—will not be the same," said Ricardo Correa, the endocrinology fellowship director at the University of Arizona College of Medicine.
Separately, Karl Nadolsky, an endocrinologist at Spectrum Health, said that "the consensus amongst legitimate practicing obesity endocrinology specialists is to avoid this, because it's just too much unknown."
Novo Nordisk has also warned customers about counterfeit versions of semaglutide being sold in some retail pharmacies across the United States. The medication was packaged with a fake label and carton that could be mistaken for an authentic Ozempic pen.
The Medicines and Health Products Regulatory Agency in the United Kingdom has also reported the seizure of hundreds of "potentially fake Ozempic pens since January 2023."
According to Shabbir Safdar, a pharmacist and executive director for the Partnership for Safe Medicines, fake Ozempic drugs are often re-labeled insulin shots. Although some patients may not be aware that they took a counterfeit version of the drug, other patients could experience significant side effects, including hypoglycemia, stroke, and coma.
FDA is currently investigating several reports of serious side effects associated with the use of counterfeit semaglutide, including hospitalization and death.
So far, 42 reports of adverse side effects associated with counterfeit semaglutide have been submitted to FDA's Adverse Event Reporting System. Of these cases, 28 were classified as "serious," including at least three hospitalizations and two deaths.
"The FDA will investigate any report of suspect counterfeit drugs to determine the public health risks and the appropriate regulatory response," said Jeremy Kahn, an FDA spokesperson. "The FDA remains vigilant in protecting the U.S. drug supply from these threats."
Separately, Novo Nordisk said it is working with FDA to bring awareness to the potential of counterfeit semaglutide. "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," a company spokesperson said.
FDA has also voiced concerns about semaglutide alternatives, including compounded versions of the drug. "FDA has received an increased number of adverse event reports and complaints concerning these compounded drug products," the agency said in a recent letter to pharmacy boards.
To reduce the risk of receiving a counterfeit drug, Florencia Halperin, CMO at Form Health and an expert in GLP-1 drugs and obesity medicine, said patients should only obtain semaglutide with a prescription through a trusted source.
"Because the drugs in question are prescription medications that are regulated by the FDA, people should only receive them under the care of healthcare professionals who are licensed in their state to treat and prescribe, and it is important to look this up if anyone has any doubts," Halperin said.
Halperin also noted that patients should receive standard medical care when getting prescriptions for these drugs. "[D]id the prescriber ask about drug allergies, other medications, or medical history? Did they verify height and weight?" she said. "[I]f none of this information is collected, this should raise a red flag." (Diaz, New York Post, 11/8; Tin, CBS News, 11/7; Andrews, Daily Mail, 11/8; Schimelpfening, Healthline, 11/8)
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