After Wegovy and Ozempic stayed on the drug shortage list for nearly three years, the Food and Drug Administration (FDA) announced on February 21, 2025, that semaglutide is no longer in shortage.
Semaglutide is one type of active ingredient in glucagon-like peptide-1 (GLP-1) receptor agonist drugs, widely known as type 2 diabetes treatment (Ozempic) and weight loss medication for obesity (Wegovy).
With the FDA's announcement, state-licensed compounding pharmacies only have until April 22 to stop making copies of popular semaglutide products.
Unfortunately, this might not be the last time we will hear about compounded drugs and, in addition, counterfeit products. These supplies, often misrepresented in ads, remain accessible through means that are unreported to the FDA. This alarming situation warranted an announcement from the Federal Bureau of Investigation (FBI) that counterfeit drugs were circulating from fraudulent compounding. The FBI mentioned in its warning released on February 28, 2025, that a semaglutide medication compounded in Georgia was found to have "animal-grade" semaglutide and traces of vitamin B12.
When a drug is added to the FDA's shortage list, licensed pharmacies may be allowed to formulate copies of medicines. Ideally, each drug is compounded specifically for what one patient needs. Several problems arise due to the unregulated nature of drug compounding, where the FDA does not oversee its production and the patients have no way of knowing about the exact contents of the drug.
The original GLP-1 drugs, produced by companies like Novo Nordisk and Eli Lilly, are already involved in more than a thousand lawsuits under MDL 3094 in Eastern Pennsylvania for semaglutide and tirzepatide's adverse side effects. The unknown factors that come with compounding only leave more room for added risks in the safety and efficacy of the compounded drugs.
The risks of pharmaceutical compounding come down to these three things: it is unregulated, it is not required by the FDA to adhere to good manufacturing practice regulations (GMPR), and pharmacies are not required to report any adverse reactions to the FDA.
A study published in Pharmaceutical Research found impurities and impurity patterns in compounded injectable semaglutide products, including trace metals and residual solvents. The amount of semaglutide in drug products studied was found to be lower than what was declared on the label. The liraglutide products sampled were found to be less stable compared to FDA-approved versions.
On top of uncertainties in content, compounded drugs are also prone to misuse. A journal article in The Journal of the Endocrine Society featured the case of a 31-year-old female with obesity who bought semaglutide from a compounding pharmacy and injected the drug incorrectly at 2.5mg/0.5mL, ten times the amount prescribed. Most FDA-approved injections were pre-filled in 0.25 mg or 0.5 mg increments. This case highlights the danger of unregulated formulations that are easy to acquire and prone to wrong dosing. When adverse events like this occur, compounding pharmacies are not obliged to report these events to the FDA, something that original manufacturers are required to do, which could lead to a significant underreporting reflected in data.
According to the FDA, more than 392 adverse events related to compounded semaglutide had been reported as of November 30, 2024. More than 215 had been reported for tirzepatide. No lawsuit involving adverse events from compounded semaglutide has been reported to have been filed yet.
Even as the shortage ends, patients might still prefer to buy compounded medication because these are the only affordable treatment options for type 2 diabetes treatment and weight loss. When the supply of compounded drugs runs out in April and May, the rise in advertisements for counterfeit drugs will bring a new problem to the GLP-1 industry.
The FDA has released several warnings over the years about being vigilant when buying semaglutide products (Ozempic, Wegovy, Rybelsus). If you have suffered from adverse side effects from taking semaglutide products you might be eligible to file a claim.
Semaglutide has been linked to gastroparesis (stomach paralysis), bowel obstruction, and vision loss. If you have been diagnosed with these conditions after taking semaglutide, contact Atraxia Law to get a case evaluation over the phone.