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People with heart disease need to be careful about using the common antibiotic clarithromycin, the Food and Drug Administration said Thursday.
Heart disease patients who take the drug, sold under the brand name Biaxin, can die years later, the FDA said.
The FDA said it does not know how clarithromycin might cause heart problems or death, but it’s been warning about the problem since 2005. But a review of data 10 years later shows heart patients still have a higher risk of dying if they took the antibiotic for two weeks.
“FDA is advising caution before prescribing the antibiotic clarithromycin (Biaxin) to patients with heart disease because of a potential increased risk of heart problems or death that can occur years later,” the FDA said in a statement.
“Healthcare professionalsshould be aware of these significant risks and weigh the benefits and risks of clarithromycin before prescribing it to any patient, particularly in patients with heart disease and even for short periods, and consider using other available antibiotics,” it added.
“Advise patients with heart disease of the signs and symptoms of cardiovascular problems, regardless of the medical condition for which you are treating them with clarithromycin.”
Clarithromycin can be prescribed to treat infections of the skin, ears, sinuses and lungs. It’s also favored for treating Mycobacterium avium complex (MAC) infection, a type of lung infection that often affects people with human immunodeficiency virus (HIV).
Patients with heart disease need to make sure they tell doctors who may prescribe the antibiotic – especially if it’s not their regular doctor.
“Talk to them about the benefits and risks of clarithromycin and any alternative treatments,” the FDA said.
“Do not stop taking your heart disease medicine or antibiotic without first talking to your healthcare professionals. Doing so could be harmful without your health care professionals’ direct supervision,” it added.
“Seek medical attention immediately if you experience symptoms of a heart attack or stroke, such as chest pain, shortness of breath or trouble breathing, pain or weakness in one part or side of your body, or slurred speech.”