The Obesity Society (TOS) has acknowledged the FDA’s recent announcement declaring the end of shortages for Novo Nordisk's Wegovy and Ozempic; two critical medications in the treatment of obesity and diabetes. This development signifies a pivotal advancement in patient care, ensuring broader access to these essential, FDA-approved therapies.
This announcement follows the agency’s December decision that Eli Lilly’s tirzepatide, marketed as Zepbound for weight loss, was no longer in shortage and it would give compounders 60-90 days before putting a stop to their production of the copycat GLP-1s.
During the shortage period, compounding pharmacies were permitted to produce versions of these medications to address the supply gap. However, with the restoration of adequate supply, the necessity for compounded alternatives has been eliminated. In response to the resolution of the shortage, a group representing large facilities that make compounded versions of the medications filed a lawsuit against the FDA.
TOS urges the FDA to enforce existing regulations to cease unauthorised use of GLP-1s, as patients may unknowingly be exposed to potentially harmful or ineffective compounded GLP-1 medications, as well as fraudulent or misleading information disseminated by unauthorised compounders.
"In the case of current compounded GLP-1 treatments, the source of the active ingredient can be of questionable origin, and they likely aren’t the same molecule approved by the FDA after rigorous testing and oversight,” stated TOS President, Dr Marc-André Cornier. "Ensuring access to safe and effective medications is paramount and the end of the shortage provides an opportunity for the FDA to reinforce the importance of utilising approved therapies."
TOS remains committed to advocating for patient safety and emphasizes the critical distinction between compounded and FDA-approved GLP-1 medications. TOS calls upon healthcare providers, pharmacists, and patients to prioritize treatments that have undergone rigorous FDA evaluation to ensure efficacy and safety.
“Consumers are eager to seek treatments for obesity and rely on their healthcare team to provide guidance, explain risks, and make shared decisions,” he added. Above all else, consumers should be able to place full confidence and trust in their healthcare providers when it comes to obesity and weight management care.”
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