FDA: Serious Bleeding Risk for OTC Antacid Products
The U.S. Food and Drug Administration (FDA) is warning consumers of the serious bleeding risks associated with over-the-counter aspirin-containing antacid products.
Details on the Antacid Warning
The drug facts label should be read carefully when ingesting or purchasing these products, which are used to treat heartburn, acid indigestion, or an upset stomach.
These products already contain warnings about the risks of bleeding. This includes products such as: 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.
This issue will continue to be evaluated and external reports will be used to conclude if further FDA actions are necessary.
The FDA reporting system identified 41 cases of serious bleeding events reported with OTC products containing aspirin. These patients required hospitalization.
Among these 41 cases, one death was reported, 17 provided no details about dosing, 11 indicated that the patient ingested these products daily, others claimed to use this product inappropriately, while only 7 cases reported using this product as needed.
The majority of these patients, however, appeared to have underlying conditions that put them at risk for developing these stomach bleeding issues.
Important Information about Antacid Products
There are risk factors that higher your chance of serious bleeding when taking these products. This includes; age 60 or older, history of stomach ulcers, taking blood thinning or steroid medicine, taking other OTC pain relief, drink alcohol daily, or taking more of these medicines than what is recommended.
These products combine an antacid that neutralizes stomach acid along with aspirin.
Aspirin is an NSAID that can increase the risk of serious bleeding, whether it is in the stomach, GI tract, brain, and spinal chord. This can cause the need for hospitalization and even a blood transfusion.
Report side effects from OTC aspirin-containing antacid products or other medicines to the FDA MedWatch program, using the information in the “Contact FDA” box at the bottom of this page
This safety issue continues to be evaluated and the public will be notified of the advisory committee meeting by posting notices in the Federal Register and on the FDA Advisory Committees web page and when there is additional information to share.