- Novo Nordisk filed a lawsuit against Hims & Hers for infringing US Patent 8,129,343.
- Hims marketed unapproved semaglutide products, risking patient safety.
- Compounded semaglutide products showed impurities up to 86%.
- FDA and medical organizations warn against using knock-off GLP-1 drugs.
Legal Action
Novo Nordisk has initiated a lawsuit against Hims & Hers for infringing US Patent 8,129,343. The lawsuit targets Hims' compounded semaglutide products, which are marketed without FDA approval, posing significant risks to patient safety.
Patient Safety Concerns
Hims & Hers has been promoting unapproved versions of Novo Nordisk's semaglutide medicines, Wegovy® and Ozempic®. These products bypass the FDA's review process, potentially deceiving consumers and healthcare professionals about their safety and efficacy.
Product Impurities
Testing by Novo Nordisk revealed that compounded semaglutide products contain impurities as high as 86% for injectables and 75% for oral versions. Such impurities can lead to severe health issues, including immune responses and drug interactions.
Regulatory and Medical Warnings
The FDA and respected medical organizations, including the American Medical Association and the American Diabetes Association, have expressed concerns about the safety and quality of these knock-off GLP-1 drugs. They advise against their use due to uncertainties about their content and effectiveness.
