The U.S. Food and Drug Administration (FDA) released information on February 22, 2018, stating that patients with heart disease should use caution, before being prescribed the antibiotic clarithromycin (Biaxin). The information is based on the review of a 10-year follow-up study the FDA conducted through patients with coronary heart disease.
Through a large clinical trial, called the CLARICOR trial, it was observed that an unexpected increase in deaths among patients with coronary heart disease, who received a two-week course of clarithromycin, became apparent. These patients had been followed for one year or longer. The FDA says there is no clear explanation for how clarithromycin would lead to more deaths than placebo.
What does this mean for patients taking clarithromycin?
The FDA is recommending that patients with heart disease tell their health care provider if they are being prescribed any antibiotic to treat an infection. The organization says you should talk to your physician about the benefits and risks of clarithromycin and any alternative treatments, regardless of your heart’s condition.
What does it mean for health care professionals?
The Food and Drug Administration says health care professionals should weigh the risks and benefits of clarithromycin, before prescribing it to any patient. They should be especially mindful when prescribing the antibiotics to patients with heart disease. Officials are asking health care professionals to advise patients of the signs and symptoms of cardiovascular problems, regardless of the medical condition being treated with clarithromycin.
The FDA cannot determine whether the results of the CLARICOR trial can be applied to patients who do not have heart disease. The FDA has no prospective, randomized, or controlled trails in place for patients who do not have heart diseases.
You can read more about this story on the FDA’s website.