The safety of compounded GLP-1s has become a topic of debate following Hims & Hers’ Super Bowl ad promoting its weight loss product. These custom-made GLP-1s from compounding pharmacies contain the same active ingredients as branded versions like Ozempic and Wegovy, but with some key differences. The surge in demand for these drugs due to a shortage of branded products has led various companies to offer compounded GLP-1s, creating a new revenue stream.
Despite the FDA announcing the end of the semaglutide injectables shortage, safety concerns surrounding compounded GLP-1s persist. The debate has been fueled by the recent Hims & Hers ad during the Super Bowl, which criticized the healthcare system and promoted their weight loss offering, potentially including compounded GLP-1s.
In response, Novo Nordisk, the manufacturer of Ozempic and Wegovy, ran an ad questioning the safety of compounded GLP-1s, emphasizing that they are not FDA-approved and lack evidence of safety and efficacy. Hims & Hers, along with other digital health companies, offer access to these compounded drugs, highlighting the importance of understanding the safety and effectiveness of such medications.
While compounded medications can be prescribed in specific situations, such as a shortage of FDA-approved drugs or when a patient cannot tolerate the commercial version, concerns over safety persist. Hims & Hers CEO Andrew Dudum reassured that they will continue to provide personalized treatments within legal boundaries.
Despite claims of safety and compliance with regulations, concerns remain among healthcare professionals about the lack of safety and efficacy data for compounded agents. The debate underscores the importance of patient access and affordability to effective weight loss drugs, with Hims & Hers offering compounded GLP-1s at a lower cost compared to branded versions, potentially increasing accessibility for some patients. El primero está regulado por la FDA, mientras que el último solo está regulado por la junta estatal de farmacia. Además, cada lote de GLP-1s compuestos se analiza en busca de contaminantes, bacterias o virus.
Además del medicamento compuesto, la empresa proporciona a los consumidores acceso a un médico a través de mensajes, recursos educativos, así como apoyo nutricional y de ejercicio. Según un informe de Hims & Hers sobre su programa de pérdida de peso, menos del 20% de los pacientes han reportado efectos secundarios importantes y solo el 13% interrumpió el tratamiento en el primer mes.
WeightWatchers, una empresa de manejo de peso, también proporciona acceso a GLP-1s compuestos a partir de $129 por el primer mes y $189 por cada mes adicional. Su oferta clínica conecta a los pacientes con un clínico certificado especializado en cuidado de la obesidad, quien puede recetar GLP-1s si se considera que un paciente es elegible. El clínico también puede recetar GLP-1s de marca.
Con las versiones compuestas, WeightWatchers implementa varias precauciones que parecen ser similares a las de Hims & Hers, destacó un ejecutivo de la empresa.
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