FDA WARNING_LETTER - Currax Pharmaceuticals LLC - September 03, 2020

The FDA"s Office of Prescription Drug Promotion (OPDP) issued a Warning Letter to Nalpropion Pharmaceuticals LLC following a review of a Google sponsored link for CONTRAVE (naltrexone hydrochloride and bupropion hydrochloride). The review, prompted by a public complaint, identified that the promotional material made false or misleading claims regarding Contrave"s risks and efficacy, leading to misbranding under the Federal Food, Drug, and Cosmetic Act. The primary violations included a misleading risk presentation, as the sponsored link entirely omitted all serious and potentially life-threatening risks associated with Contrave, including its boxed warning for suicidal thoughts and behaviors. This omission created a false impression of the drug"s safety. Additionally, the link made misleading efficacy claims by failing to provide crucial information from the FDA-approved indication. It neglected to state that Contrave must be used as an adjunct to a reduced-calorie diet and increased physical activity, and omitted specific initial body mass index (BMI) criteria, the requirement for weight-related comorbid conditions, and important limitations of use. These omissions are particularly alarming due to Contrave"s serious safety profile and its application in weight management. OPDP noted similar past concerns regarding Contrave promotions by a previous application holder. Nalpropion Pharmaceuticals LLC is required to take immediate corrective action to rectify these promotional violations and ensure all future materials accurately convey both the benefits and risks of Contrave.