Clarithromycin (Biaxin): Drug Safety Communication - Potential Increased
Risk of Heart Problems or Death in Patients With Heart Disease
AUDIENCE
: Health Professional, Internal Medicine, Cardiology, Patient
ISSUE
: FDA is advising 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. FDAs
recommendation is based 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 large clinical trial, called the CLARICOR trial, observed an unexpected
increase in deaths among patients with coronary heart disease who received
a two-week course of clarithromycin that became apparent after patients had
been followed for one year or longer. There is no clear explanation for how
clarithromycin would lead to more deaths than placebo. Some observational
studies also found an increase in deaths or other serious heart-related
problems, while others did not. All the studies had limitations in how they
were designed. 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. Based on these studies, FDA is unable to determine why the
risk of death is greater for patients with heart disease.
As a result, FDA added a new warning about this increased risk of death in
patients with heart disease, and advised prescribers to consider using
other antibiotics in such patients. FDA also added the study results to the
clarithromycin drug labels. As part of FDA?s usual ongoing safety
monitoring of drugs, we are continuing to monitor safety reports in
patients taking clarithromycin.
BACKGROUND
: Clarithromycin is used to treat many types of infections affecting the
skin, ears, sinuses, lungs, and other parts of the body, including
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.
RECOMMENDATION
: 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. 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.
Patients
should tell your healthcare 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 healthcare 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.
Healthcare professionals and patients are encouraged to report adverse
events or side effects related to the use of these products to the FDA's
MedWatch Safety Information and Adverse Event Reporting Program:
Read the MedWatch Safety Alert, including a link to the FDA Drug Safety
Communication, at:
https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm597862.htm
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