FDA is investigating two deaths among women who ‘took fake Ozempic’ – as black market weight-loss shots are linked to three more hospitalizations
- Have you or someone you know been hospitalized with fake Ozempic? Contact: [email protected]
At least two Americans have died and three have been hospitalized after taking counterfeit semaglutide, including fake Ozempic, official data shows.
The reports are in the Food and Drug Administration’s (FDA) adverse event reporting system and date from July to September this year.
The two deaths were both in women who suffered from blood clotting throughout the body — medically termed disseminated intravascular coagulation.
Among the patients hospitalized was a 66-year-old woman who suffered from a serizure after injecting herself with the counterfeit drug, another woman who suffered skin discoloration and bruising and a man who suffered a liver disorder.
The system says there have been 28 reports of counterfeit semaglutide, which is the active drug used in Ozempic and Wegovy, in the US since March last year. The drugs have been labeled as Ozempic or Wegovy in some cases.
Both medications have exploded in popularity in the US triggering major shortages of the drugs and pushing many patients into ordering online — raising the risk they may be sold counterfeit, or fake, versions of the drugs.
She dropped 35lbs (16kg) over five months as she was trying to slim down for a dress for her daughter’s wedding
The reports were made to the FDA’s FAERS system, which monitors adverse effects of medication. Reports made to the database are not verified and anyone can log an incident.
All five reports of deaths and hospitalizations were submitted by Novo Nordisk, which makes Wegovy and Ozempic.
Four of the cases had been reported to the company by doctors and one had been reported by a consumer, which could include a patient, patient’s family or lawyer.
Only one of the three hospitalizations mentioned Ozempic and none of the deaths mentioned a drug beyond semaglutide.
Of the 28 reports of counterfeit semaglutide in the US, 14 — or half — were marked as ‘serious’.
A spokesman for the FDA said: ‘The FDA will investigate any report of suspect counterfeit Ozempic to determine the public health risks and the appropriate regulatory response.
‘The FDA remains vigilant in protecting the US drug supply from these threats.’
It comes amid concerns over counterfeit Ozempic in the US after regulators in the UK said the fake drugs were leaving people in a coma.
UK regulators say they have already seized 369 potentially fake Ozempic pens since the start of the year.
They have also been handling bogus versions of Saxenda, another similar weight loss drug, which had been obtained through ‘non-legitimate roots’.
Deaths can be reported to FAERS by doctors, consumers, manufacturers, family members and others.
Medical documents will not be requested in the initial report, but those submitting one will be asked to give information on the adverse event, the drug they were using, their sex and age and clinical outcome.
Reports are reviewed and constantly monitored by investigators at the FDA to search for medication side effects that may have been missed during clinical trials. They can also be warned to determine whether the public needs to be warned about counterfeit Ozempic.
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