FDA warns on compounded versions of Novo Nordisk's Ozempic, Wegovy

 In the rush to supply prescriptions of Novo Nordisk’s popular diabetes and weight loss meds, some pharmacies are making unauthorized versions of Ozempic and Wegovy, the FDA warned on Tuesday.

Some compounding pharmacies, which are permitted to make drugs during times of shortage, are using unauthorized versions of semaglutide—the key active ingredient in the GLP-1 drugs.

Compounding pharmacies are currently allowed to make Ozempic and Wegovy because they are in short supply. But they must use approved ingredients, the FDA points out.

The agency has received adverse event reports after patients have used compounded semaglutide. In some cases, compounders may be using salt forms of semaglutide, called semaglutide sodium or semaglutide acetate, which have not been proven to be safe or effective.

The FDA asks users of Ozempic and Wegovy to get a prescription from a licensed provider and only obtain drugs from state-licensed pharmacies or outsourcing facilities registered with the FDA.

The agency also suggests users of online pharmacies screen them through its BeSafeRx campaign.

Over the last several weeks, authorities in states such as Louisiana, Mississippi, North Carolina and West Virginia have threatened to take legal action against compounding pharmacies making unauthorized versions of Ozempic and Wegovy.

Five weeks ago, Novo Nordisk promised a supply boost of Wegovy after lining up a second contract manufacturer. But, during the company’s first-quarter earnings report, it said that it would “temporarily” reduce U.S. supply of lower dosage strengths of the treatment.

https://www.fiercepharma.com/pharma/fda-warns-compounded-versions-novo-nordisks-ozempic-and-wegovy