In June 2016, the U.S. Food and Drug Administration (FDA) issued a warning to consumers regarding the risk of severe bleeding associated with the use of over-the-counter (OTC), or nonprescription, antacid medications that contain aspirin.
The products involved are typically used to treat heartburn, so-called “sour” stomach, acid indigestion, or upset stomach. FDA MedWatch noted that there are numerous other products that may be used for the treatment of these conditions that do not contain aspirin.
The defective drug lawyers at Parker Waichman LLP are investigating potential lawsuit claims stemming from injuries associated with the use of aspirin-containing antacid products.
What Is Aspirin and What Does Aspirin Treat?
Aspirin is a very broadly used pain and fever reducer that is in the drug category of nonsteroidal anti-inflammatory drugs (NSAIDs). NSAIDs may increase bleeding risks, including in the stomach and gastrointestinal (GI) tract.
OTC aspirin-antacid products are sold under an array of brand, or trade names, as well as generically. Some of the more popular brands are:
- 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
Reports of Serious Events Associated with Aspirin-Containing Antacid Products Continue to be
Received by Federal Regulators
FDA indicated in its June 2016 warning that it continues to receive reports of this serious safety issue and plans to continue to evaluate the bleeding concern.
A search of the FDA Adverse Event Reporting System (FAERS) database revealed eight cases of serious bleeding events associated with these products after the warning was added. All of the patients required hospitalization and all had underlying conditions, including risk factors that put them at increased risk for developing serious bleeding events.
The FAERS database includes only those reports that are submitted to the FDA; therefore, federal regulators believe there are likely additional cases about which the agency is unaware. In response to these reports, the FDA intends on convening an advisory committee of external experts to provide input about if more FDA actions are necessary.
Risk Factors for Increased Serious Bleeding Events When Taking Aspirin-Antacid Drugs
If you have one or more of the following risk factors, you may have a higher likelihood for a serious bleeding event when taking aspirin-containing antacid products:
- You are 60 years of age or older
- You are taking a blood-thinner drug
- You are taking a steroid medication
- You are taking NSAID medications, including ibuprofen or naproxen
- You are taking more blood thinners, steroids, and/or NSAIDs than the amount recommended, or for a longer period of time than recommended
- You drink three or more alcoholic beverages every day
- You have a history of stomach ulcers
- You have a history of bleeding problems
Legal Help for Victims of Aspirin-Antacid Bleeding Events
If you or someone you know sustained a serious bleeding event following use of aspirin-containing antacid products, you may have valuable legal rights. We urge you to contact our Aspirin-Antacid Bleeding lawyers today by filling out our online form, or calling 1-800-YOURLAWYER (1-800-968-7529).