On June 6, 2016, the FDA warned consumers about the risk of serious bleeding when using over-the-counter (OTC) aspirin-containing antacid products to treat heartburn, sour stomach, acid indigestion, or upset stomach. Many other products for these conditions are available that do not contain aspirin.
These widely used products already contain warnings about this bleeding risk on their labels. However, the FDA is continuing to receive reports of this serious safety issue. As a result, the agency will continue to evaluate this safety concern. Next year, The FDA plans to hold an advisory committee of external experts. They will provide input about whether additional actions are needed by the FDA to address the risk of serious bleeding with aspirin-containing antacid products. After receiving input, the agency will determine what, if any, actions are needed. These actions could include requiring manufacturers to put additional warnings on the product label, changing permitted combinations of active ingredients, or changing approved treatments for aspirin-antacid combination products.
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 generic products.
Consumers should always read the Drug Facts label carefully when purchasing or taking an OTC product to treat heartburn, acid indigestion, or sour or upset stomach. If the product contains aspirin, consider whether a patient should choose a product without aspirin to relieve symptoms.
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. If a patient has one or more of the following risk factors, the patient may have a higher chance of serious bleeding when taking aspirin-containing antacid products:
- Are 60 years or older
- Have a history of stomach ulcers or bleeding problems
- Take a blood-thinning or steroid medicine
- Take other medicines containing NSAIDs such as ibuprofen or naproxen
- Drink three or more alcoholic drinks every day
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 the risk of serious bleeding was added to the labels of all OTC products that contain 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. All of these patients were hospitalized. Patients had underlying conditions such as the risk factors above that put them at greater risk for developing serious bleeding events.
A search of the (FAERS) database from January 1, 1969, through August 13, 2014, identified 41 cases of serious bleeding events reported with over-the-counter (OTC) products containing aspirin, sodium bicarbonate, and citric acid. All patients experienced serious outcomes resulting in hospitalization, and 21 patients required transfusions due to blood loss. Most of the patients recovered. One death was reported but the case provided few details of the patient’s underlying medical conditions or the cause of death.
The majority of patients using the aspirin-containing antacid products appeared to have had underlying conditions that put them at risk for developing serious bleeding events, particularly gastrointestinal bleeding events. Risk factors for developing bleeding were reported in 88% (36/41) of the cases, and included age greater than 60 years (n=23); use of anticoagulants, steroids, or nonsteroidal anti-inflammatory drugs (n=28); history of stomach ulcers (n=4); or history of alcohol abuse (n=5).
See the FDA Drug Safety Alert
See also Medical Law Perspectives, May 2013 Report: Drugs, Dosage, and Damage: Physician Liability for Prescribing or Administering Medication