FDA Backs Tougher Warnings For Nexium, Prilosec

Law360, New York (November 4, 2014, 3:38 PM EST) -- The U.S. Food and Drug Administration will require stronger warnings regarding risks associated with Nexium, Prilosec and other popular heartburn drugs, concluding that doctors and patients should know more about potential drug interactions and side effects.

The agency’s action was disclosed Friday in response to a 2011 petition from nonprofit group Public Citizen Inc., which sued the FDA in April in hopes of forcing regulators to address the petition’s concerns. Although Public Citizen’s petition was granted in several respects, the FDA also shot down portions calling for black box warnings, instead confining new risks to standard labeling sections.

On Monday, Public...

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