Aspirin-Antacid Bleeding Risk
The U.S. Food and Drug Administration (FDA) is warning consumers about the risk of serious bleeding when using nonprescription, also known as over-the-counter or OTC, aspirin-containing antacid products to treat heartburn, sour stomach, acid indigestion, or upset stomach.
Aspirin is a commonly used pain reducer and fever reducer. It is a nonsteroidal anti-inflammatory drug (NSAID) that can increase the risk of bleeding, including in the stomach and gastrointestinal (GI) tract.
In a Safety Communication issued on June 6, 2016, The U.S. Food and Drug Administration (FDA) publicized the risk of serious bleeding when using over-the-counter (nonprescription) aspirin-containing antacid products. The FDA cautioned consumers to consider this risk when looking for an antacid to treat heartburn, sour stomach, acid indigestion, or upset stomach.
Aspirin is a commonly used pain reducer and fever reducer, but may increase the risk of bleeding, including in the stomach and gastrointestinal tract.
Aspirin-Anacid Products
Over-the-counter aspirin-antacid products are available as generic products, and also 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.
FDA Warns of Risk
This risk of serious bleeding is indicated on these products’ labeling. In a 2009 Press Announcement, manufacturers were required to supplement the labels of all over-the-counter products that contain aspirin with a warning about the risk of serious bleeding. This requirement also included aspirin-containing antacid products.
However, despite the labeled warning, the FDA continues to receive reports of bleeding cases caused by aspirin-antacids. The FDA Adverse Event Reporting System found eight cases of serious bleeding events associated with these products after the warning was added, though this count only includes reports submitted to FDA, so there are likely additional cases about which we are unaware.
All of the patients who reported to have had suffered bleeding due to aspirin-antacid products were hospitalized. All patients had underlying conditions which put them at greater risk for developing serious bleeding events.
See the FDA Consumer Update for more information on risk factors that may make you more susceptible to bleeding from aspirin-antacid products.
Call the Weinberg Law Firm to Obtain a Free Medical Malpractice Lawsuit Case Evaluation
If you or a family member has been injured as a result of a medication error, and you have a question regarding your legal rights, you can request a free medical malpractice lawsuit case evaluation from our firm by calling us toll free at 1-877-934-6274. Our phones are answered 24/7. You can also contact our law firm online by using the easy-to-use case evaluation form found on this page.
