FDA is investigating two deaths among women who ‘took fake Ozempic’ – as black market weight-loss shots are linked to three more hospitalizations

At least two Americans have died and three have been hospitalized after taking counterfeit semaglutide, including counterfeit Ozempic, official data shows.

The reports are included in the Food and Drug Administration’s (FDA) Adverse Event Reporting System and date from July to September of this year.

The two deaths both occurred in women who suffered from blood clotting throughout the body – medically called disseminated intravascular coagulation.

Among the patients hospitalized were a 66-year-old woman who developed serizure after injecting herself with the counterfeit drug, another woman who suffered skin discoloration and bruising and a man who suffered from liver disease.

The system says there have been 28 reports of counterfeit semaglutide, the active drug used in Ozempic and Wegovy, in the US since March last year. The medications are labeled as Ozempic or Wegovy in some cases.

Both drugs have exploded in popularity in the U.S., causing major shortages of the drugs and prompting many patients to order online, increasing the risk of being sold counterfeit versions of the drugs.

The reports were made to the FDA’s FAERS system, which monitors the adverse effects of drugs. Reports to the database are not verified and anyone can report an incident.

Both the deaths and two of the hospitalizations due to counterfeit semaglutide in the system were committed by doctors, who are required to report these events.

One of the reported hospitalizations – in the 66-year-old woman – was made by a consumer, including a patient, a patient family or an attorney.

Deaths can be reported to FAERS by physicians, consumers, manufacturers, family members and others.

The initial report will not ask for medical documents, but those who submit one will be asked to provide information about the adverse event, the drug they took, their gender and age and the clinical outcome.

Reports are reviewed and continually monitored by FDA investigators to look for drug side effects that may have been missed during clinical trials. They can also be alerted to determine whether the public should be warned about counterfeit Ozempic.

An FDA spokesperson said: ‘The FDA will investigate any report of suspected counterfeit Ozempic to determine the public health risk and appropriate regulatory response.

“The FDA remains vigilant in protecting the U.S. drug supply from these threats.”