FDA issues warning on overdoses of Ozempic and other weight-loss drugs

People are overdosing on Ozempic and other popular weight loss drugs, according to a warning from the Food and Drug Administration.

In a report published on Monday, the FDA detailed health incidents, including hospitalizations, associated with weight lossdrugs containing semaglutide, an antidiabetic medication. The active ingredient has been approved by the FDA in three popular weight loss drugs: Ozempic, Wegovy, and Rybelsus.

Overdoses may have arisen from patients with poor knowledge of drug measurements and medical equipment, such as syringes, as well as health care providers who miscalculated doses, FDA officials wrote.

The FDA acknowledged that while compounded drugs containing semaglutide have been marketed for weight loss, they have not been approved for this use by the government health agency.

Patients overdosed by as much as five to 20 times the intended dose with adverse side effects including severe nausea, vomiting, headache, dehydration, pancreatitis, gallstones, and severely low blood sugar levels, according to the FDA.

FDA-approved semaglutide products are currently only available in pre-filled pens containing standard measurements and concentrations. In one case, a patient who used compounded semaglutide tried to measure a dose in units and accidentally took 10 times more than the intended dose.

“FDA encourages patients to talk with their health care provider or compounder about how to measure and administer the intended dose of compounded semaglutide,” officials wrote.

The health agency added that “health care providers should be vigilant when prescribing and administering compounded semaglutide, as there may be different concentrations available. If uncertain, health care providers should contact the compounder about calculating the correct dose of medication to prescribe or administer.”

Ozempic sales have grown more than 60 percent over the last year making its main manufacturer, Novo Nordisk, the biggest company in Europe in 2023.Celebrities from Sharon Osbourne to Boy George have spoken candidly about their use of Ozempic. “I was injecting myself with Ozempic and I lost three stone in four months,” Osbourne told The Guardian in February.

Yet some scientists have raised concerns around the potential health effects of drugs with semaglutide and other weight loss ingredients. Long-term effects of Ozempic remain largely unknown, and can mask, rather than address, underlying conditions, according to New York University bioethicist Arthur Caplan.

“As soon as you go off [weight loss drugs], you’re gonna put the weight back on because you haven’t made any changes. So just to sell it and say, ‘Here, a magic bullet. You can use it as an injectable and it’ll be great’ means you’re gonna be on that drug for life unless you do something about the underlying condition,” Caplan told WBUR.

The FDA is asking patients and health officials to report any health incidents related to compounded semaglutide products.