WEDNESDAY, May 1 (HealthDay News) -- The widely used antibiotic azithromycin (Zithromax or Zmax) -- under scrutiny recently because it may increase the risk of death for those with existing heart disease -- appears to be safe for young and middle-aged adults without heart problems, according to a large new study.
Danish researchers evaluated more than a million episodes of azithromycin use, comparing it to both the use of no antibiotics and to the use of penicillin V, from 1997 through 2010. Patients were aged 18 to 64.
"We believe that the results are reassuring," said Henrik Svanstrom, a researcher at Statens Serum Institute, in Copenhagen. His study is published in the May 2 issue of the New England Journal of Medicine.
"Our study shows no increased risk in the general population of young and middle-aged adults," he said. That, he added, "would reinforce the hypothesis that any increased risk of cardiovascular [death] associated with azithromycin is restricted to high-risk patients -- for instance [those] with a history of cardiovascular disease."
More than 56 million prescriptions were written for azithromycin in the United States in 2011, according to the IMS Institute for Healthcare Informatics. That compares to about 54 million written in 2011 for amoxicillin, another popular antibiotic.
Azithromycin is prescribed for bacterial sinusitis, pneumonia, skin infections and infections linked with lung disease, among other problems.
Concern about azithromycin surfaced in 2012, after a study in which researchers estimated an absolute risk of 47 cardiovascular deaths for every 1 million prescriptions for azithromycin. The study prompted a statement from the U.S. Food and Drug Association, cautioning that those taking the drug should be aware of the potential for heart problems.
In March 2013, the FDA renewed the warning, cautioning that the dru
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