1. Pink Sheet

FDA Fast Talk: Health Advisories with Unclear Advice

 
• By Ramsey Baghdadi

FDA is trying to get safety messages out to consumers more rapidly. A recent warning on Nexium and Prilosec shows how complicated these early warnings can be.

What happens when FDA makes an announcement about a possible health issue but really doesn’t have anything to say? FDA’s recent review of AstraZeneca PLC ’s esomeprazole (Nexium) underscores exactly how squeezed the agency is right now.

On August 9, FDA put out a health advisory and scheduled a media call with associate director for safety policy and communication Paul Seligman, MD, to announce new information related...

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