FDA warns on risk of heart problems with antibiotic Biaxin

The US Food and Drug Administration 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.

Biaxin was originated by US drugmaker Abbott Laboratories, and was most recently marketed by spin-out AbbVie (NYSE: ABBV), but is now off patent, with generic copies coming onto the market since around 2006.

The FDA’s recommendation is based on a review of the results of a 10-year follow-up study of patients with coronary heart disease from a large clinical trial that first observed this safety issue.