FDA Drug Safety Communication: FDA review finds additional data supports the potential for increased long-term risks with antibiotic clarithromycin (Biaxin) in patients with heart disease

The U.S. Food and Drug Administration (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. Our recommendation is based on our review of the results of a 10-year follow-up study1 of patients with coronary heart disease from a large clinical trial2 that first observed this safety issue.
Source: FDA Center for Drug Evaluation and Research - What's New - Category: Drugs & Pharmacology Source Type: news