FDA Warning: Aspirin-Antacids Can Cause Bleeding

June 7, 2016 — The FDA has issued a Safety Communication to warn about the risk of severe bleeding from over-the-counter (OTC) antacids containing aspirin.

Antacids are used to treat heartburn or “sour stomach.” There are many antacids that do not contain aspirin or cause bleeding.

The labels on aspirin-antacid drugs were updated to include warnings about bleeding in April 2009. Since then, the FDA has received eight reports of bleeding. It is likely that more cases were never reported.

All of the patients were hospitalized and had underlying medical conditions or risk-factors for bleeding.

The risk of bleeding increases for patients who are over 60 years old, have a history of stomach ulcers or bleeding problems, take a blood-thinning or steroid medicine, take ibuprofen or naproxen, or drink three or more alcoholic drinks every day.

List of OTC aspirin-antacids:

• Alka-Seltzer Original
• Bromo Seltzer
• Medique Medi Seltzer
• Picot Plus Effervescent
• Vida Mia Pain Relief
• Winco Foods Effervescent Antacid and Pain Relief
• Zee-Seltzer Antacid and Pain Reliever
• And more

Aspirin is a non-steroidal anti-inflammatory drug (NSAID) that is commonly used to reduce pain and fever. It increases the risk of bleeding in the stomach, gastrointestinal (GI) tract, brain, and apinal cord. Serious bleeding can lead to hospitalization or the need for a blood transfusion.

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