FDAnews Drug Daily Bulletin

FDA Releases Warning on OTC Aspirin-Containing Heartburn Drugs

June 13, 2016

The FDA has issued a warning about the risk of serious bleeding when using OTC drugs containing aspirin used to treat heartburn, sour stomach acid indigestion or upset stomach.

While these products are already sold with warnings of bleeding, there have been continued reports of the issue, the agency says.

The FDA added that it will continue to evaluate the issue and plan an advisory committee meeting to provide input regarding whether additional agency actions are needed.

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