The Food and Drug Administration (FDA) has issued a warning about an alarming number of overdoses related to popular weight-loss drugs, including Ozempic. The FDA’s report, published on Monday, highlights a series of health incidents, including hospitalizations, linked to semaglutide-containing medications, which are primarily used for diabetes management but have gained popularity for weight loss.
The Issue
Semaglutide, the active ingredient in Ozempic, Wegovy, and Rybelsus, has been associated with a growing number of overdoses. According to the FDA, these incidents may be due to patients’ lack of understanding of drug measurements and medical equipment, such as syringes, as well as healthcare providers’ miscalculations of doses.
The FDA specifically noted that while compounded drugs containing semaglutide are being marketed for weight loss, they are not approved for this purpose. The agency reported cases where patients overdosed by as much as five to twenty times the recommended dose, resulting in severe side effects, including nausea, vomiting, headache, dehydration, pancreatitis, gallstones, and hypoglycemia.
Concerns and Recommendations
FDA-approved semaglutide products are currently dispensed in pre-filled pens with standardized dosages. In one case, a patient using a compounded version mistakenly took ten times the intended dose due to a misunderstanding of measurement units. The FDA urges patients to consult with healthcare providers or compounders to ensure proper dosing of compounded semaglutide.
Healthcare providers are advised to be cautious when prescribing and administering compounded semaglutide, especially given the variability in available concentrations. If there is uncertainty, they should consult with the compounder to verify the correct dosage.
Growing Popularity and Potential Risks
Sales of Ozempic have surged over the past year, with its manufacturer, Novo Nordisk, becoming the largest company in Europe in 2023. Celebrities like Sharon Osbourne have openly discussed their use of the drug, citing significant weight loss. However, some experts express concerns about the long-term health effects of semaglutide-based drugs and their potential to merely mask underlying conditions without addressing them.
Arthur Caplan, a bioethicist at New York University, warned that relying on these medications without lifestyle changes could result in patients regaining weight once they stop taking the drugs. “As soon as you go off [weight loss drugs], you’re gonna put the weight back on because you haven’t made any changes,” Caplan told WBUR.
FDA’s Call to Action
The FDA encourages patients and healthcare professionals to report any adverse events related to compounded semaglutide products. This call for vigilance comes as the agency continues to monitor the safety and efficacy of these popular yet potentially risky weight-loss medications.
