The FDA announced on Thursday that health care providers should be careful before prescribing clarithromycin, an antibiotic drug, to heart disease patients. The drug has been found to increase the risk of additional heart problems in later years and even early death.
Clarithromycin, sold under the name of Biaxin, is generally given to patients afflicted with infections that impact areas such as the lungs, ears, skin, and sinuses, according to a MedWatch drug safety communication alert by FDA.
FDA released the alert after reviewing a 10-year data from the prospective placebo-controlled CLARICOR trial. It showed that people with coronary heart diseases who had received a two-week clarithromycin course had a higher number of deaths at least one year after the treatment was completed.
Based on these studies, FDA is unable to determine why the risk of death is greater for patients with heart disease.
"Clarithromycin increased mortality due to cardiovascular death outside hospital and cerebrovascular morbidity in patients with stable coronary heart disease who were not on statin," the data stated.
Cautionary Advice For Clarithromycin Prescription
Of the six published observational studies to date in patients, both afflicted and not afflicted with coronary artery disease, two observational studies saw that the drug was associated with long-term heart-related issues. The overall results of the trial provide the strongest proof of the higher risk compared to the observational study results.
The FDA still does not know why there is a greater death risk for those with a heart disease, but it has recommended health care professionals to weigh the benefits and risks of clarithromycin before recommending it to patients with heart disease.
The alert has stated that the results for CLARICOR haven been added to the labeling of clarithromycin. FDA has advised patients to alert their medical provider if they have heart disease. Patients, who are prescribed with clarithromycin and experience symptoms of a myocardial infarction have been asked to get immediate medical attention.
“Healthcare 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,” FDA stated in the alert. “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.”