> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Orexigen TV Spot Misleads About Contrave: FDA
- URL: https://www.fdaweb.com/orexigen-tv-spot-misleads-about-contrave-fda/
- Published: 2017-05-24T12:00:00.000Z
- Updated: 2026-09-14T22:25:36.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5138778

The CDER Office of Prescription Drug Promotion (OPDP) says a direct-to-consumer TV ad for Orexigen’s Contrave (naltrexone HCl and bupropion HCl) extended-release tablets makes false or misleading representations about the risks associated with the drug. “This violation is concerning from a public health perspective because it creates a misleading impression about the safety of Contrave,” OPDP says in a 5/18 [untitled letter](https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/ucm560127.htm?ref=fdaweb.com).

The letter says Contrave is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with a specified body mass index. It is associated with a number of serious risks, including suicidal thoughts and behaviors and neuropsychiatric reactions. The labeling includes several Contraindications, Warnings, and Precautions.

OPDP says the TV spot is misleading because it includes efficacy claims for Contrave but does not include important risk information. Thus, the spot says “Do not take with opioids,” but fails to include any of the other conditions for which Contrave is contraindicated. The letter says the ad also is misleading because it communicates important risk information in the visual portion of the ad only, through superimposed text, and presents unrelated risk information in competing audio messages.

OPDP asked that the company stop using violative promotional materials and respond with a list of materials containing violations discussed in the letter and a plan for discontinuing use of those materials.