DDMAC: Reliant Pharmaceuticals promotion doesn’t include any risk information
Pharma Compliance Alert, September 20, 2006
Reliant Pharmaceuticals failed to communicate any risk information in promotions for its drug Rythmol SR, even though the drug's label has a black box warning, according to a warning letter from DDMAC. The drug's label also includes other warnings, contraindications, precautions, and potential adverse reactions.
According to DDMAC, although the ads reference "full prescribing information, including Boxed Warning," at the bottom, this note is not sufficient. Because the ads didn't contain any risk information, they misleadingly suggest that the drug is safer than it has been shown to be.
In addition to not including risk information, the promotions suggest that the drug is safe and effective for use in a broader patient population or conditions than clinical evidence shows.
DDMAC has requested that Reliant immediately stop distributing the promotion and respond to the letter in writing by September 30. Read the entire warning letter on DDMAC's Web site.
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