FDA warns of drug compounding amid shortages of drugs containing semaglutide

FDA warns of drug compounding amid shortages of drugs containing semaglutide | Image Credit: © Iryna - © Iryna - stock.adobe.com.

The FDA is warning providers and patients of drug compounding amid shortages of multiple FDA-approved products containing semaglutide.

Currently, 3 products containing semaglutide are FDA-approved, including the Wegovy (Novo Nordisk) injection to help children 12 years and older with obesity lose and keep off weight. An Ozempic (Novo Nordisk) injection and Rybelsus (Novo Nordisk) tablets are also FDA-approved products containing semaglutide to lower blood sugar levels in adults with type 2 diabetes mellitus. Currently, there are no approved generic versions for these medications, and all 3 are only available with a prescription.¹

First posted to the FDA drug shortages list on March 31, 2023, and as of May 2023, Wegovy 0.25 mg / 0.5 mL, 0.5 mg / 0.5 mL, and 1 mg / 0.5 mL injections have limited availability through September 2023, citing an increased demand as cause for the shortage.²

According to a press release from the FDA, semaglutide belongs to a class of medications; glucagon-like peptide-1 (GLP-1) receptor agonists, mimicking the GLP-1 hormone that is released in the gastrointestinal tract in response to eating. GLP-1 prompts the body to produce more insulin, reducing blood glucose or sugar. In higher amounts, GLP-1 interacts with the portion of the brain that reduces appetite and signals a feeling of fullness, the FDA states.¹

Because of drug shortages, drug compounding–the process of combining, mixing, or altering ingredients to create a medication tailored to the needs of an individual patient–can take place. Compounding includes combining 2 or more drugs. These compounded drugs “are not FDA-approved, and the agency does not verify the safety or effectiveness of compounded drugs,” the press release states.¹

Adverse events have been reported to the FDA after patients used compounded semaglutide. The agency reiterates to patients and health care professionals compounded drugs are not reviewed by the FDA for safety, effectiveness, or quality, and that patients should not use a compounded drug if an approved drug is available.

The FDA has also received reports that compounders may be using salt forms of semaglutide in some cases, including semaglutide sodium and semaglutide acetate. “The agency is not aware of any basis for compounding using the salt forms that would meet the FD&C requirements for types of active ingredients that can be compounded. On April 27, 2023, FDA wrote to the National Association of Boards of Pharmacy expressing the agency’s concerns with use of the salt forms in compounded products,” the press release states.

Reference:

1. Medications containing semaglutide marketed for type 2 diabetes or weight loss. FDA. May 31, 2023. Accessed June 7, 2023. https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/medications-containing-semaglutide-marketed-type-2-diabetes-or-weight-loss

2. FDA drug shortages. FDA. Revised May 4, 2023. Accessed June 7, 2023. https://www.accessdata.fda.gov/scripts/drugshortages/dsp_ActiveIngredientDetails.cfm?AI=Semaglutide%20(WEGOVY%C2%AE)%20Injection&st=c