The U.S. Food and Drug Administration (FDA) is adding new warnings about the increased risk of death in patients with heart disease, and recommending that doctors consider prescribing other antibiotics.
Patients should seek medical attention immediately for symptoms of a heart attack or stroke, such as chest pain, trouble breathing, pain or weakness on one side or one part of the body, or slurred speech.
Biaxin (clarithromyxin) has been on the market for more than 25 years. It is sold under the brand-name Biaxin® and many generics. It is used to treat infection of the skin, ears, sinuses, lungs, and more.
The FDA is also asking patients to tell their health care professionals if you have heart disease, especially when you are being prescribed an antibiotic to treat an infection.
The FDA issued a warning after a large clinical trial discovered an increased risk of serious heart-related problems or death among patients with heart disease who took clarithromycin for 2 weeks.
There is no clear explanation for how clarithromycin would lead to more deaths than placebo. There is a possibility that patients without heart disease could also be at risk of heart-related problems or death, but the FDA does not have enough information to know for sure.