STORY FROM: Drugs & Medical Devices

FDA Warns of Serious Bleeding Risk Posed by OTC Aspirin-Containing Antacids

WASHINGTON, D.C. — The Food and Drug Administration is warning consumers that over-the-counter aspirin-containing antacid drugs used to treat heartburn, acid indigestion and upset stomach pose a risk of serious bleeding.

In a June 6 Drug Safety Communication, the agency noted that while the products already warn of bleeding risk, it is continuing to receive reports of serious bleeding. As such, the FDA says it “will continue to evaluate this safety concern and plan to convene an advisory committee of external reports to provide input regarding whether additional FDA actions are needed.”

OTC aspirin-antacid products are sold under various names, ...

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