US FDA issues alert on Abbott antibiotic
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U.S. regulators alerted the public on Friday to a study showing a higher death rate among heart disease patients one year after taking the Abbott Laboratories Inc. antibiotic Biaxin, 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 Thursday in the British Medical Journal, evaluated data from about 4,373 Danish heart disease patients who took Biaxin (clarithromycin) 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 as well as similar drugs have not detected any increase in deaths.
“A mechanism by which two weeks of clarithromycin could cause increased mortality measured after one year or longer is not clear,” the FDA notice said.
The agency described the alert as a preliminary analysis. “FDA is considering, but has not reached a final conclusion about, this information,” it said.
FDA spokeswoman Laura Alvey said the agency issued the alert “in the spirit of full disclosure.”
After criticism over their handling of drug safety controversies, FDA officials promised earlier this year they would release more information about potential risks.
Abbott spokesman Brian Kyhos said the Danish findings were “at odds with 50 years of data and patient experience” with macrolides, the family of antibiotics that includes Biaxin, which has been sold for 15 years.
“We believe the results are a random finding,” he said.
Kyhos said there was no evidence Biaxin could permanently damage the heart. The drug stays in the body for only 36 hours.
“It is important to be careful not to create undue alarm for patients,” he said.
The Biaxin alert was posted on the FDA Web site at http://www.fda.gov/cder/drug/infopage/clarithromycin/default.htm
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