Public Citizen petitions the FDA to add black box warnings to all proton pump inhibitors presently on the market in the USA

Public Citizen petitions the FDA to add black box warnings to all proton pump inhibitors presently on the market in the USA

Public Citizen, a research-based advocacy group representing more than 225,000 members and supporters, has petitioned the Food and Drug Administration (FDA) to immediately add black box warnings and other safety information concerning several severe risks to the product labels of all proton pump inhibitors (PPIs) presently on the market in the United States (Nexium, Dexilant, Prilosec, Zegerid, Prevacid, Protonix, Aciphex, Vimovo, Prilosec OTC, Zegerid OTC, Prevacid 24-Hr, and all generic counterparts). In addition, the serious nature of so many of these adverse reactions also mandates the requirement for FDA-approved patient Medication Guides, none of which exist now, for all of these drugs.

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