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FDA: Bleeding Risk from OTC Antacids That Contain Aspirin

June 7, 2016 — The FDA is warning that over-the-counter (OTC) anti-heartburn drugs that contain aspirin can cause severe bleeding.

Antacids decrease the amount of acid made by the stomach. They are used to prevent “sour stomach” or treat painful ulcers. Some products contain aspirin, a pain-reliever and fever-reducer in the Non-Steroidal Anti-Inflammatory Drug (NSAID) class.

In April 2009, the FDA updated the label on all NSAIDs to include warnings about severe bleeding.

Unfortunately, the FDA has continued to receive reports of bleeding. The risk is low — only eight cases have been reported since 2009. From 1969 to 2014, the agency received 41 reports. All of the patients were hospitalized.

There are many antacids on the market that do not contain aspirin or cause bleeding. The FDA is evaluating the need for further regulatory action on this safety concern.

In the meantime, the agency asks patients to consider where they can use a product without aspirin to relieve symptoms.

The FDA is also warning about risk-factors that may increase the risk of bleeding. These include age (being over 60 years old), history of stomach ulcers or bleeding, taking blood-thinners or steroid medicines, taking other NSAIDs like ibuprofen or naproxen, or drinking three or more alcoholic beverages per 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

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