FDA: Novartis promotional magnet violates rules
Pharma Compliance Alert, May 14, 2008
A Partial Seizure Lenticular Magnet for Novartis’ Trileptal misbrands the drug because it omits the full indication and risk information, according to an FDA warning letter.
The magnet presents a danger to public health because it may encourage physicians to use Trileptal off-label and suggests Trileptal is safer and more effective than demonstrated, according to the FDA.
The full indication and risk information is located on the back of the magnet, but the FDA considers this impractical because the content is not visible when the magnet adheres to magnetic surfaces. “Presenting indication and risk information in this manner is not sufficient to ensure that the claims on the magnet are truthful and non-misleading,” according to the FDA letter.
The FDA instructed Novartis to stop disseminating the magnets and provide a written plan for discontinuing its use. The FDA also requested Novartis include its plan to disseminate truthful, non-misleading, and complete corrective messages.
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