The US FDA has warned consumers about the risk of serious bleeding when using over-the-counter (OTC) aspirin-containing antacid products to treat heartburn, sour stomach, acid indigestion, or upset stomach. A search of the FDA Adverse Event Reporting System (FAERS) database identified eight cases of serious bleeding events associated with these products after the warning was added. All of these patients were hospitalized. As a result, the FDA will continue to evaluate this safety concern and plan to convene an advisory committee of external experts to provide input regarding whether additional actions are needed.
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