Alka-Seltzer and Other Antacids with Aspirin Carry Bleeding Risks, FDA Warns

Adverse event reports indicate some users suffered stomach bleeds serious enough to require blood transfusions

Federal health officials are warning that many popular, over-the-counter antacids containing aspirin, such as Alka-Seltzer, carry an increased risk of stomach or intestinal bleeding, and should be avoided by some consumers.

The U.S. Food and Drug Administration issued an antacid warning on November 7, urging consumers to avoid taking products that contain aspirin, especially if they are already vulnerable to stomach bleeds. This includes those ages 60 and older, individuals with a history of stomach ulcers, heavy alcohol drinkers and patients taking certain medications.

Aspirin is a non-steroidal anti-inflammatory drug (NSAID), and is commonly used to reduce fever or pain. Prior research has linked NSAIDs to increased risk of stomach or intestinal bleeding.

FDA Receives Reports of Stomach Bleeds Linked to Some Antacids

The FDA warns that taking antacids containing aspirin to treat heartburn, sour stomach, acid indigestion, or upset stomach can increase a person’s risk of suffering from bleeding.

While such bleeding incidents are rare, the agency notes it has reviewed the Adverse Event Reporting System database, and found new cases of serious bleeding caused by aspirin-containing antacids, like Alka-Seltzer.

The FDA first issued a warning about the antacid combination drug, and the risk of intestinal bleeds in 2009. However, despite the warning, new cases of stomach bleeds continue to be reported. Some patients who suffered intestinal bleeding required a blood transfusion, according to those reports.

“We’re focusing on bleeding risk specifically with antacid-aspirin products used to treat upset stomach or heartburn,” Dr. Karen Murry, Deputy Director of the Office of Nonprescription Drugs at the FDA, states in the warning. “We’re not telling people to stop taking aspirin altogether.”

FDA Antacid Recommendations

If the label of the medication includes aspirin, consumers should consider using something else, the FDA advises. There are many antacid medications that don’t contain aspirin, such as Nexium.

Warning signs of stomach or intestinal bleeding may include feeling faint, vomiting blood, passing black or bloody stools, or having abdominal pain. Consumers who suffer from these symptoms should contact a doctor right away.

Since aspirin works as a blood thinner, some people face a higher risk of intestinal or stomach bleeding, especially those with multiple risk factors. The FDA recommends individuals who have been taking antacids with aspirin for some time contact a doctor for medical advice. Those experiencing frequent or chronic upset stomachs should see a doctor right away.

Some patients face increased risk of stomach or intestinal bleeds, including:

• People who are 60 years old or older
• Those with a history of stomach ulcers or bleeding problems
• Those taking anticoagulants, drugs that reduce the ability of the blood to clot
• People taking steroid medicines, like prednisone
• Those taking other medications containing NSAIDs, like Advil or Aleve
• Anyone who drinks three or more alcoholic drinks per day

If a doctor has recommended taking daily aspirin to reduce the risk of heart attack or stroke, do not stop taking it without consulting the doctor first.

Consumers can look for alternative medications to treat upset stomach, heartburn, and indigestion that don’t include aspirin. Some of those medicines contain “antacid” or “acid reducers” on the label or packaging.

For frequent heartburn, there are other over-the-counter and prescription medications that might help.

The FDA requests those who have experienced stomach or intestinal bleeding after taking aspirin-containing antacids, report the incident to the FDA’s MedWatch Adverse Event Reporting program.