Healthcare providers should exercise caution when prescribing the macrolide antibiotic clarithromycin (Biaxin, generics) to patients with coronary heart disease because of a potential increased risk for heart problems or death that can occur years later, the US Food and Drug Administration (FDA) said today in a safety communication.
The FDA's recommendation is based on 10-year follow-up results of the CLARICOR study, which found an "unexpected" increase in deaths among patients with coronary heart disease who received a 2-week course of clarithromycin that became apparent after patients had been followed for at least 1 year, the agency said.
The FDA first issued an alert on clarithromycin in 2005, before the 10-year follow-up results from CLARICOR were available, but did not recommend any specific changes to the use of clarithromycin at that time.
On the basis of the new data, the FDA has added a new warning about the increased risk for death in patients with heart disease and advised prescribers to consider using other antibiotics in such patients. The study results have also been added to the clarithromycin label.
Clarithromycin is used to treat a variety of infections affecting the skin, ears, sinuses, lungs, and other parts of the body, including Mycobacterium avium complex (MAC) infection, a lung infection that often affects people with HIV, the FDA alert notes. It is not approved to treat heart disease.
The FDA said there is "no clear explanation" for how clarithromycin would lead to more deaths than placebo. Of the six observational studies published to date in patients with or without coronary artery disease, two found evidence of long-term risks from clarithromycin and four did not.
"Overall, results from the prospective, placebo-controlled CLARICOR trial provide the strongest evidence of the increase in risk compared to the observational study results," the FDA said.
They said it was unclear at present whether results of the CLARICOR trial can be applied to patients who do not have heart disease.
he FDA advises healthcare professionals to 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."
The FDA is continuing to monitor safety reports in patients taking clarithromycin. The agency encourages healthcare providers to report adverse events or side effects related to clarithromycin to MedWatch, the FDA's safety information and adverse event reporting program.