The study, in a Medicaid population, included nearly 350,000 azithromycin prescriptions, 1.4 million control periods without antibiotic prescriptions, and 1.8 million prescriptions for other antibiotics, mostly amoxicillin.
Azithromycin conferred a nearly threefold increase in risk for CV death and a nearly twofold increase in all-cause mortality during the 5 days of therapy, relative to no treatment. When azithromycin and amoxicillin were compared, there were 47 excess CV deaths per 1 million courses of azithromycin. For patients with the highest CV risk at baseline, there were 245 excess deaths per 1 million azithromycin treatments, compared with amoxicillin.
Azithromycin also posed greater risk for CV mortality compared with ciprofloxacin, but not compared with levofloxacin.
The following are some of reports published on different News sites:
The New York Times reports "A new study finds that a widely used antibiotic, azithromycin, may increase the likelihood of sudden death in adults, especially those who have heart disease or are at high risk for it." While "the increased odds of death are small," they are "significant enough that the authors of the study say doctors should consider prescribing a different drug, like amoxicillin, for high-risk patients who need antibiotics." Individuals "at high risk include those with heart failure, diabetes or a previous heart attack, and those who have undergone bypass surgery or have had stents implanted."
The AP reports that for the study, published in New England Journal of Medicine, "Vanderbilt University researchers analyzed health records and data on millions of prescriptions for several antibiotics given to about 540,000 Tennessee Medicaid patients from 1992 to 2006." The investigators found that "there were 29 heart-related deaths among those who took Zithromax [azithromycin] during five days of treatment. Their risk of death while taking the drug was more than double that of patients on another antibiotic, amoxicillin, or those who took none."
The ABC News "Medical Unit" blog reports that "Wayne Ray...lead author of the study, says he thinks many doctors prescribe azithromycin instead of amoxicillin because of its easier regimen; patients on azithromycin take fewer pills over fewer days, which means they are more likely to finish their entire course of medicine. Finishing the entire course not only leads to more effective treatment, but it also lessens the risk of the patient developing a drug-resistant bug." However, "Ray says of azithromycin, 'the risk of death may outweigh convenience and compliance, at least for high-risk patients.'"
In HIV and ID Observations, Dr. Paul Sax writes: "If there's a silver lining to this report ... it's that clinicians will stop prescribing azithromycin for conditions that clearly don't need it — which is just about every uncomplicated outpatient respiratory infection. ... Hey, we can dream, can't we?"
ARTICLE CITATION : NEJM
by
AKSHAYA SRIKANTH
Pharm.D Resident
Hyderabad, India
FDA Responds to Study on Azithromycin and Cardiovascular Death
ReplyDeletePatients should not stop taking the antibiotic azithromycin without first consulting with their physician, the FDA said in a statement following a study published in the New England Journal of Medicine — and covered here Thursday.
That study linked the drug with increased risk for cardiovascular death during short-term therapy. The FDA notes that other macrolide antibiotics also carry warnings about possible QT interval prolongation.
The agency says it's reviewing the work and that "healthcare professionals should be aware of the potential for QT interval prolongation and heart arrhythmias when prescribing or administering macrolides."
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm304503.htm