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news.The US Food and Drug Administration (FDA) is warning consumers about the risk of severe bleeding when using over-the-counter (OTC) aspirin-containing antacid products.
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Since it issued a warning on serious bleeding risk with aspirin in 2009, the agency has recorded eight new cases of severe bleeding caused by aspirin-containing antacid products. In some of those cases, patients required a blood transfusion.
People with a higher risk of serious bleeding with aspirin-containing antacid products include those aged 60 and older; who have a history of stomach ulcers or bleeding problems.
People are also at higher risk for bleeding if they take anticoagulants; steroid medication; other medicines containing nonsteroidal anti-inflammatory drugs such as ibuprofen or naproxen; and who drink three or more alcoholic drinks a day.
FDA deputy director of the division of nonprescription drug products Karen Murry Mahoney said: "Today we’re focusing on bleeding risk specifically with antacid-aspirin products used to treat upset stomach or heartburn. We’re not telling people to stop taking aspirin altogether.
The agency said it will continue to assess the safety issue and plans to convene an advisory committee of external experts in 2017 to see what further regulatory action is required.
The FDA urged the consumers to always read the Drug Facts label carefully when purchasing or taking an OTC product.
If the product features aspirin, users are advised to look for something else which don’t contain aspirin.