Welcome to FDA Drug Safety Podcasts for health care professionals. This is Lesley Navin, Advanced Practice Nurse from the Division of Drug Information.
On June 6, 2016, FDA warned 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.
These products already contain warnings about this bleeding risk on their labels; however, we continue to receive reports of this serious safety issue. 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.
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 generics.
Aspirin is a nonsteroidal anti-inflammatory drug (NSAID) that can increase the risk of bleeding, including in the stomach and gastrointestinal tract. Patients with certain risk factors may have a higher chance of serious bleeding when taking aspirin-containing antacid products.
Taking more of these medicines than the amount recommended or for a longer period than recommended will increase the risk of serious bleeding.
In 2009, a warning about this risk was added to the labels of all OTC products containing NSAIDs, including aspirin-containing antacid products. However, a search of the FDA Adverse Event Reporting System (FAERS) database identified eight cases of serious bleeding events associated with these products after the warning was added. These patients were hospitalized and had underlying conditions that put them at greater risk for developing serious bleeding events. The FAERS database includes only reports submitted to FDA. There are likely additional cases about which we are unaware.
We are continuing to evaluate this safety issue and will notify the public of the advisory committee meeting by posting notices in the Federal Register and on the FDA Advisory Committees web page.
Report side effects involving OTC aspirin-containing antacid products to FDA’s MedWatch program at www.fda.gov/medwatch.
A link to the full communication detailing information for health care professionals, risk factors that may increase serious bleeding risk when taking aspirin-containing antacid products, and the complete Data Summary can be found at www.fda.gov/DrugSafetyCommunications. If you have drug questions, you can reach us at [email protected].
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