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FDA Alert: Antacid With Aspirin Linked to GI Bleeds

June 6, 2016
FDA issues renewed warning after 8 cases of gastrointestinal bleeds were linked to over-the-counter antacid medications that contained aspirin.

The Food and Drug Administration (FDA) is warning physicians and consumers about the risk of serious bleeding when using over-the-counter (OTC) aspirin-containing antacid products. Many other products for these conditions are available that do not contain aspirin.

According to an alert from the agency, "These widely used products already contain warnings about this bleeding risk on their labels; however, we are continuing to receive reports of this serious safety issue. As a result, we will continue to evaluate this safety concern and plan to convene an advisory committee of external experts to provide input regarding whether additional FDA actions are needed."

Antacid product like Alka-Seltzer Original contain aspirin, which has been linked to increased risk of gastrointestinal bleedings.OTC aspirin-antacid products are sold under various trade names, including Alka-Seltzer Original, Bromo Seltzer, Medique Medi Seltzer, Picot Plus Effervescent, Vida Mia Pain Relief, Winco Foods Effervescent Antacid and Pain Relief, and Zee-Seltzer Antacid and Pain Reliever. They are also available as generic products, noted the FDA/

Physicians should caution patients who have GI issues or are taking pain medications to read the Drug Facts label carefully when purchasing or taking an OTC product to treat heartburn, acid indigestion, or sour or upset stomach. If the product contains aspirin, counsel patients to consider choosing a product without aspirin to relieve your symptoms.

In 2009, the FDA added a warning about the risk of serious bleeding  to the labels of all OTC products that contain NSAIDs, including aspirin-containing antacid products. However, a search of the FDA Adverse Event Reporting System (FAERS) database identified 8 cases of serious bleeding events associated with these products after the warning was added, noted the agency.

All of these patients were hospitalized, said the FDA.  "Patients had underlying conditions that put them at greater risk for developing serious bleeding events," said the press release. The FAERS database includes only reports submitted to FDA so there are likely additional cases about which we are unaware.

The following are considered risk factors of serious bleeding when taking aspirin-containing antacid products:

  • 60 years or older
  • Have a history of stomach ulcers or bleeding problems
  • Take a blood-thinning or steroid medicine
  • Take other medicines containing NSAIDs such as ibuprofen or naproxen
  • Drink 3 or more alcoholic drinks per day

For more information, please visit: OTC Antacid Products

Last updated on: March 5, 2019
Continue Reading:
FDA Alert: Tramadol Use in Children

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