FDA Proposes Liver, GI Risk Warnings For OTC Pain Relievers
This article was originally published in The Tan Sheet
FDA proposes adding warnings on labeling for OTC pain relievers to advise consumers of "potential health risks" associated with acetaminophen and NSAIDs such as aspirin, ibuprofen and naproxen
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Existing science on the safety and efficacy of OTC acetaminophen does not substantiate several FDA-proposed warnings to be included in labeling for the analgesic, McNeil Consumer Healthcare asserts
FDA's proposed changes to warning flags displayed on the front of some OTC pain relief products "would benefit from greater flexibility," according to the Consumer Healthcare Products Association
Sen. Chuck Grassley, R-Iowa, asks FDA to account for its lag time in reacting to acetaminophen safety concerns in a March 20 letter to Commissioner Andrew von Eschenbach