Biaxin alert

2005-12-16 09:02:50 AM
US FDA issues alert on study of Abbott antibiotic
By Lisa RichwineFri Dec 9, 6:50 PM ET
U.S. regulators alerted the public on Friday 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 Thursday 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.
"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
www.fda.gov/cder/drug/infopage/clarithromycin/default.htm .
-