Saturday, June 3, 2023

 

  • On Tuesday, the FDA posted information about medications containing semaglutide marketed for type 2 diabetes or weight loss. There are currently three FDA-approved semaglutide products which are only available with a prescription. Due to two of the drugs being in shortage, these two drugs are able to be compounded if they meet certain requirements in the Federal Food, Drug, and Cosmetic Act. The FDA has received adverse event reports after patients used compounded semaglutide. The FDA has also received reports that in some cases, compounders may be using salt forms of semaglutide, including semaglutide sodium and semaglutide acetate, which have not been shown to be safe or effective. The salt forms are different active ingredients than is used the approved drugs, which contain the base form of semaglutide. Patients should be aware that some products sold as ‘semaglutide’ may not contain the same active ingredient as FDA-approved semaglutide products and may be the salt formulations. Patients should only obtain drugs containing semaglutide with a prescription from a licensed health care provider, and only obtain medicines from state-licensed pharmacies or outsourcing facilities registered with the FDA.
FDA Newsroom

No comments: