FDA warns against using off-brand versions of Ozempic, Wegovy for weight loss

FDA has warned consumers against using ‘compounded’ versions of semaglutide, the key ingredient found in Ozempic and Wegovy

The United States Food and Drug Administration has issued a warning to consumers not to use off-brand versions of the popular weight-loss drugs Ozempic and Wegovy because they may not include the same ingredient included in the FDA-approved medications.

This week, agency officials said they have received reports of problems after patients used versions of semaglutide, the key active ingredient in the GLP-1 medication, that were compounded – or mixed using two or more drugs – in pharmacies. Compounded drugs are not FDA-approved, and the agency does not verify the safety or effectiveness of compounded drugs.

“FDA has received adverse event reports after patients used compounded semaglutide,” the notice said. “Patients should not use a compounded drug if an approved drug is available to treat a patient. Patients and health care professionals should understand that the agency does not review compounded versions of these drugs for safety, effectiveness, or quality.”

The FDA also reported that compounders “may be using salt forms of semaglutide”, including semaglutide sodium and semaglutide acetate, which are different active ingredients than the one used the FDA-approved drugs.

Consumers should only use drugs containing semaglutide with a prescription from a licensed health care provider and obtained from a state-licensed pharmacy or other facilities registered with the FDA, the agency said.

Sales of semaglutide products have soared in the past few years after the drug was shown to spur fast and significant weight loss. The drugs manufactured by Novo Nordisk include brands Ozempic and Rybelsus, used to treat diabetes, and Wegovy, approved to treat obesity.

However, increased demand has also led to a shortage of the medications. As of May, Ozempic and Wegovy remain on the FDA’s list of drug shortages.

Ozempic is a once-weekly antidiabetic injection used for the treatment of Type 2 diabetes, although some of its side effects include weight loss. Ozempic – which is the brand name for semaglutide – works by mimicking a hormone that regulates appetite, which creates the feeling of fullness.

Meanwhile, Wegovy is another once-weekly semaglutide injection specifically approved for the treatment of obesity and weight loss.

Additional reporting by the AP.