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US FDA cites Baxter for misleading Feiba promotion

This article was originally published in Scrip

Executive Summary

A promotional email for Baxter Healthcare's haemophilia treatment Feiba VH makes misleading safety and efficacy claims, the US FDAsaid. A "clinical thank you email" for the anti-inhibitor coagulant complex claims a 60% efficacy rate with one infusion, but this is inconsistent with the product's labelling. The promotion also minimises the fact that serious thrombotic events can occur with Feiba, and reported adverse events do not support the email's claim that Feiba is "well tolerated in 96-100% of infusions". Baxter said the email was a one-time communication used last year. The company is working to address the agency's concerns and ensure that appropriate contextual information is included in promotions to adequately support safety and efficacy claims.






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