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By the Editors
The antibiotic clarithromycin's label will be updated to warn of an increased mortality risk when used in patients with heart disease, the FDA announced on Thursday. Clinicians were instructed to consider prescribing other antibiotics for these patients.
A 10-year study found that patients with coronary heart disease had an increased risk for heart problems and mortality after using clarithromycin for 2 weeks. The risk "became apparent after patients had been followed for one year or longer."
Researchers have not identified a potential reason behind the increased mortality risk
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LINK(S):
FDA MedWatch safety alert (Free)
Background: Physician's First Watch coverage of clarithromycin and cardiovascular safety (Free)
Background: NEJM Journal Watch Cardiology coverage of early results of the CLARICOR trial (Your NEJM Journal Watch registration required)