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News From the Food and Drug Administration
April 3, 2018

Another Caution for Clarithromycin

JAMA. 2018;319(13):1314. doi:10.1001/jama.2018.2945

Prescribing the antibiotic clarithromycin for patients with stable coronary heart disease could increase their risk of dying of cardiovascular disease or developing cerebrovascular disease, the FDA has warned.

The agency’s recent drug safety communication is based on 10 years of follow-up from a trial involving 4372 patients with stable coronary heart disease. For 2 weeks, half received a placebo and half received 500 mg per day of clarithromycin. Overall, the drug conferred a 10% increased risk of death from any cause and a 19% increased risk of developing cerebrovascular disease.