Clarithromycin can be prescribed to treat infections of the skin, ears, sinuses and lungs.
'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, ' the FDA wrote. The CLARICOR trial observed 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 a year or more. Patients with heart disease need to make sure they tell doctors who may prescribe the antibiotic. At this time, it is unclear why the antibiotic would result in an increased risk of death compared with placebo, according to the release.
There's no clear explanation for how clarithromycin would increase heart disease patients' risk of death, the FDA said in a news release.
"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.
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 Food and Drug Administration's (FDA) warning is only the most recent in a recent spate of findings that suggest that many antibiotics may have unsafe effects on diseased hearts.
CLARICOR study data has been added to the labels for the therapy, and the administration has noted that it will continue to monitor the safety reports for the patients taking the antibiotic. Clarithromycin is not approved to treat heart disease.
"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", it added.
They should 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.
He said, "Although this study suggests an association between this specific antibiotic, there have not been any direct correlations to increased heart disease". 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.