FDA Policy/General

OPDP Hits Contrave Sponsored Link

CDER’s Office of Prescription Drug Promotion (OPDP) has issued Nalpropion Pharmaceuticals a Warning Letter about a sponsored link appearing on Google’s search engine for Contrave (naltrexone hydrochloride and bupropion hydrochloride), citing the company for false or misleading claims about the risks associated with the drug’s efficacy. “These violations are especially concerning from a public health perspective because Contrave is a drug with multiple serious, potentially life-threatening risks, including a boxed warning that describes the risk of suicidal thoughts and behaviors,” the letter says. Contrave is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults.

The sponsored link included the following claims: “Contrave Weight Loss — (naltrexone HCl/bupropion HCl)” and “Lose 2-4x more weight on average than with diet and exercise alone!” FDA’s letter, however, said the sponsored link entirely omits all risk information. “We note the sponsored link includes the statement ‘View Important Safety Info & Boxed Warning,’ however, this statement does not mitigate the misleading omission of risk information,” it said. “By omitting the risks associated with Contrave, the sponsored link fails to provide material information about the consequences that may result from the use of the drug and creates a misleading impression about the drug’s safety.”

OPDP noted that it has previously cited concerns with Contrave’s promotional materials. On 5/18/2017, the ad unit sent the application holder at the time, Orexigen Therapeutics, an Untitled Letter for a Contrave broadcast television commercial that omitted important risk information. It contended that the agency is “concerned that Nalpropion is continuing promotion of Contrave in a manner that similarly fails to adequately convey risk information.”

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome