Warn Patients About Risk From Antacids With Aspirin, FDA Says

Disclosures

June 06, 2016

Clinicians should warn patients about the risk for serious bleeding that comes with over-the-counter (OTC), aspirin-containing antacids for heartburn, acid indigestion, and sour or upset stomach, the US Food and Drug Administration (FDA) announced today.

It's not a new warning. In 2009, the FDA added the risk for serious bleeding to the labels of all OTC products, including antacids, that contain aspirin and other nonsteroidal anti-inflammatory drugs (NSAIDs). However, the agency said in a news release today that it has received reports of eight serious bleeding events associated with aspirin-containing antacids since 2009. In each case, the patient landed in the hospital.

Serious bleeding is more likely for patients who

  • Are older than 60 years of age;

  • Have a history of stomach ulcers or bleeding problems;

  • Take an anticoagulant or steroid medicine;

  • Take another drug containing an NSAID; or

  • Drink three or more alcoholic beverages each day.

Consumers considering an OTC antacid should study the label to see whether it contains aspirin. There are OTC products without aspirin that also can relieve their stomach problems, the agency noted.

More information about today's announcement is on the FDA website.

To report any problems with aspirin-containing antacids, contact MedWatch, the FDA's safety information and adverse event reporting program, by telephone at 1-800-FDA-1088; by fax at 1-800-FDA-0178; online at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm; with postage-paid FDA form 3500, available at http://www.fda.gov/MedWatch/getforms.htm; or by mail to MedWatch, 5600 Fishers Lane, Rockville, Maryland 20852-9787.

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