OTC Antacid/Aspirin Bleeding Risk Raises Concerns At CDER

CDER publishes a Drug Safety Communication, a consumer announcement and a MedWatch notice warning about the risk of serious bleeding when using OTC aspirin-containing antacid products.

FDA plans in 2017 to ask an advisory committee whether a risk of serious bleeding linked to use of OTC antacid/aspirin products should spur further agency action than a label warning currently required for the products.

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