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February 22, 2018: FDA Cautions – Potential For Increased Long-term Risks With Clarithromycin Use In Patients With Heart Disease

FDA Cautions – Potential For Increased Long-term Risks With Clarithromycin Use In Patients With Heart Disease

In a Safety Announcement dated February 22, 2018, the U.S. Food and Drug Administration (FDA) advised 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. The FDA based its recommendations 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.

The FDA has added a new warning about this increased risk of death in patients with heart disease, and advised prescribers to consider using other antibiotics in these patients. The study results were also added to the clarithromycin drug labeling. The FDA will continue to monitor safety reports in patients taking clarithromycin.

Information For Health Care Professionals

The Safety Announcement advised that Health Care Professionals should:

“…be aware of these significant risks and weigh the benefits and risks of clarithromycin before prescribing it to any patient, particularly in patients with heart disease and even for short periods, and consider using other available antibiotics. Advise patients with heart disease of the signs and symptoms of cardiovascular problems, regardless of the medical condition for which you are treating them with clarithromycin.”

Information For Patients

Patients are advised to:

“Tell your health care professionals if you have heart disease, especially when you are being prescribed an antibiotic to treat an infection. Talk to them about the benefits and risks of clarithromycin and any alternative treatments. Do not stop taking your heart disease medicine or antibiotic without first talking to your health care professionals. Doing so could be harmful without your health care professionals’ direct supervision. Seek medical attention immediately if you experience symptoms of a heart attack or stroke, such as chest pain, shortness of breath or trouble breathing, pain or weakness in one part or side of your body, or slurred speech.”

About Clarithromycin

Clarithromycin (Biaxin) is an antibiotic prescribed to treat infections affecting the skin, ears, sinuses, lungs, and other parts of the body. Clarithromycin is also prescribed to treat Mycobacterium avium complex (MAC) infection, a type of lung infection that often affects people with human immunodeficiency virus (HIV). Clarithromycin is not approved to treat heart disease.

Clarithromycin was approved by the FDA in 1991. It is marketed under the brand name Biaxin and as the generic, clarithromycin, by multiple drug companies. Clarithromycin works by stopping the growth of bacteria. Without treatment, some infections can spread and lead to serious health problems.

Clinical Trial Reveals Potential For Increased Long-term Risks With Clarithromycin Use In Patients With Heart Disease

The FDA recommendations and labeling changes are based on observations from a large clinical trial called the CLARICOR trial. In this prospective, placebo-controlled study, an unexpected increase in deaths, among patients with coronary heart disease who received a two-week course of clarithromycin, became apparent after patients had been followed for one year or longer. The FDA stated that “there is no clear explanation for how clarithromycin would lead to more deaths than placebo.”

The FDA also considered results from six observational studies, some of which also found an increase in deaths or other serious heart-related problems, while others did not.

Please see FDA Clarithromycin Safety to for information regarding the Safety Announcement and Clarithromycin Studies. The FDA urges health care professionals and patients to report side effects involving clarithromycin and other drugs to the FDA MedWatch Program.

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