FDA SAFETY ALERT ON COMPOUNDED SEMAGLUTIDE

Following reports of serious adverse events, some requiring hospitalization, the U.S. Food and Drug Administration (FDA) issued a safety alert on dosing errors observed with compounded injectable semaglutide products. Reported adverse events ranged from gastrointestinal effects (e.g., nausea, vomiting, abdominal pain) to acute pancreatitis, dehydration, and gallstones. Other reports included adverse effects of fainting, headache, and migraine. Most reports included patient dosing errors caused by drawing up greater than the prescribed dose from a multiple-dose vial for self-administration with doses ranging from five to 20 times greater than the intended dose. In general, patients were not able to measure the intended dose using a syringe. Additional reports of five to 10-time greater doses occurred due to health care professionals (HCPs) miscalculating the intended dose when converting from milligrams to units or milliliters. Compounded semaglutide products can be supplied in various containers (e.g., multi-dose vials, prefilled syringes) as well as different concentrations. Instructions accompanying compounded products may state to administer in units; however, the volume of this may vary depending on the concentration. In some cases, the product syringes supplied with the semaglutide have been significantly larger than the prescribed volume. The FDA reminds HCPs, patients, and compounders that compounded products should only be used when medical needs are unable to be met by an FDA-approved medication as these products carry a higher risk due to lack of premarket review for safety, efficacy, or quality.

ILLEGAL SALES OF SEMAGLUTIDE ONLINE

A Research Letter published in JAMA Network Open summarizes a qualitative study evaluating the safety and risk of no-prescription online semaglutide purchases. Following online searches conducted in July 2023 on Google and Bing for websites advertising sale of semaglutide without a prescription, two 0.25 mg per dose prefilled pens or equivalent semaglutide injection vials were ordered from each website. Visual inspection of the product compared to the genuine Ozempic® 1 mg prefilled pen was performed as well as quality assessments evaluating sterility and microbiological contamination. Liquid chromatography–mass spectrometry (LC-MS) was utilized to quantify active ingredients in the products. Of the 1,080 hyperlinks identified from the searches, 29.35% (317) were for online pharmacies with nearly half of these (134 sites) belonging to illegal pharmacy operations. Most sites (70% [763]) did not offer products for sale with many of these being news or informational in nature. Approximately 14% of the sites were for telemedicine and required a consultation to obtain a prescription before purchase. Test buys were conducted for six online vendors that were not recommended or were considered rogue by LegitScript and/or National Association of Boards of Pharmacy. Only three of the six products were received as three of the vendors had non-delivery scams requesting extra payments. Of the delivered products, visual inspection demonstrated discrepancies in regulatory registration information and labeling. One sample demonstrated elevated endotoxin levels (potential contamination). Although all samples contained semaglutide, purity levels were lower (7% to 14%) than advertised (99%) and measured semaglutide was substantially greater than the labeled amount for each sample (29% to 39%) resulting in consumers receiving up to 39% more semaglutide per injection. Authors concluded semaglutide products are being sold through illegal online pharmacies without a prescription and increased calls to U.S. poison centers further demonstrate the importance of increased pharmacovigilance of illegal online sales. The FDA has sent warning letters to two of the websites for unlawful sale of unapproved and misbranded semaglutide.