What You Should Know

On December 9, 2005 the FDA alerted the public to a study showing a higher death rate among heart disease patients a year after taking an Abbott Laboratories Inc. antibiotic, as part of an effort to release early information about potential safety concerns.

Officials have not reached a final conclusion about the information, the notice on the Food and Drug Administration Web site said.

Abbott described the results as "a random finding" that contrasted with decades of other research.

The study, published December 8, 2005 in the British Medical Journal, evaluated data from about 4,373 Danish heart disease patients who took the drug, Biaxin, or a placebo for 14 days. Patients ranged in age from 18 to 85.

Researchers said 9.8 percent of Biaxin patients died within three years of treatment, compared with 7.8 percent of people who got a placebo. There were no differences in the death rates until a year following therapy.

The scientists said the result was surprising and that the long-term safety of Biaxin should be further examined.

The FDA said it was not recommending any changes in use of the drug based on the finding. Previous studies of Biaxin, known generically as clarithromycin, as well as similar drugs have not detected any increase in deaths.

Article key :  Biaxin, 2009