Journal ad for Bystolic misleading
Pharma Compliance Alert, September 10, 2008
Forest Laboratories’ eight-page journal ad for Bystolic claims the drug is safer and more effective than has been demonstrated, according to an FDA warning letter.
- Makes unsubstantiated superiority and mechanism of action claims
- Omits and minimizes risks
- Makes unsubstantiated efficacy claims
The FDA wants Forest Laboratories to stop using the ad and submit a plan for how it will disseminate truthful, non-misleading, and complete corrective messages.
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