A new FDA alert issues a warning about prescribing the antibiotic clarithromycin (Biaxin) for patients with heart disease due to a potential increased risk of cardiac problems or death that can occur years later. The FDA recommendation is based upon a review of a ten-year follow-up study of patients with heart disease from a large clinical trial.
In the CLARICOR trial researchers found an increase in unexpected deaths among patients with coronary heart disease who had received a two-week course of clarithromycin. There is currently no clear explanation for this, though when looking at six observational studies that have been published, two found evidence of long term risks from clarithromycin.
As a result, the FDA has added a new warning for this medication and is advising prescribers to consider using other antibiotics in this patient population. The FDA will continue to monitor this issue and encourages healthcare professionals to report any adverse events or side effects from clarithromycin to the FDA via the online MedWatch program.
The FDA recommends weighing the risks and benefits before prescribing clarithromycin to patients with known heart disease, even for short periods. Other available antibiotics should be considered. Providers should speak with patients about the signs and symptoms of cardiovascular disease, regardless of the reason they are being treated with clarithromycin. The FDA Drug Safety Communication can be found here.