The American Diabetes Association (ADA) has issued a warning against the use of compounded versions of GLP-1 agonist drugs due to supply shortages from manufacturers Novo Nordisk and Eli Lilly.
The ADA emphasizes the potential risks associated with compounded drugs, which may not meet FDA safety and quality standards. Compounded drugs may contain additional ingredients or altered formulations that could lead to dosing errors and adverse health effects.
The ADA encourages healthcare professionals and patients to consider the safety, quality, and effectiveness of compounded medications.
The soaring demand for GLP-1 medications has resulted in periodic shortages, leading some physicians and patients to seek alternatives from compounding pharmacies. However, the ADA warns that compounded versions may not provide the same therapeutic benefits as branded drugs.
The FDA has declared the availability of certain GLP-1 medications and has warned compounding pharmacies about legal restrictions on their formulations. The compounding industry has filed a lawsuit against the FDA challenging these regulations.
Former FDA commissioner Scott Gottlieb has criticized the agency for allowing compounded versions of certain drugs to remain on the market.
The ADA's guidance highlights the importance of adhering to established safety standards in drug formulation. Compounding pharmacies have become a focal point in the discussion surrounding access to GLP-1 medications.
The potential for dosing errors and adverse events underscores the need for rigorous oversight and adherence to FDA standards.
Hims and Hers, a company marketing compounded semaglutide, has been promoting its products to draw attention to potential disruptions if stricter regulations are enforced.
The tension between patient access and regulatory compliance continues to shape the landscape of diabetes and obesity treatment. Healthcare professionals, patients, and regulatory bodies must navigate the complexities of compounded medications while prioritizing safety and effectiveness.