Use of the antibiotic clarithromycin may potentially increase the risk for heart problems or death in patients with heart disease, according to a new safety communication from the Food and Drug Administration (FDA). As such, the Agency is asking healthcare professionals to use caution before prescribing the antibiotic to this patient population.

Clarithromycin, a macrolide antibiotic, is used to treat various infections including mild to moderate susceptible pharyngitis/tonsillitis, acute bacterial exacerbation of chronic bronchitis, community-acquired pneumonia, acute maxillary sinusitis, acute otitis media, uncomplicated skin and skin structure infections, and Mycobaterium avium complex infection.

The recommendation was made after the FDA reviewed the results of a 10-year follow-up of the CLARICOR trial, which investigated the effects of clarithromycin in patients with stable coronary heart disease. In CLARICOR, patients treated for 2 weeks with clarithromycin were found to be at increased risk for all-cause mortality and cardiovascular death during the first 2.6 years of follow-up; this effect was found to persist over the 10 year follow-up period.

As a result, a new warning has been added to the prescribing information for clarithromycin to alert prescribers of this increased risk in patients with heart disease. Clinicians are being advised to weigh the benefits and risks of clarithromycin use and consider alternatives for these patients, even if clarithromycin is being used for a short period of time.

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The FDA plans to continue monitoring safety reports in patients taking clarithromycin. At this time, the Agency is unable to determine whether the results of the CLARICOR trial can be applied to patients without heart disease.

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