Post by Patti on Dec 15, 2005 9:03:15 GMT -5
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Lexington Herald-Leader
Lexington KY
December 8, 2005
FDA issues alert on Biaxin based on study
Associated Press
WASHINGTON - The Food and Drug Administration issued an alert Friday involving Biaxin, an antibiotic made by Abbott Laboratories.
The agency issued an alert to patients and health care professionals discussing a study done on patients with heart disease in Denmark. Biaxin, known generically as clarithromycin, was associated with a "higher chance of death from heart problems," the FDA said. The study was published Thursday in the British Medical Journal.
But, the agency also said, it was not recommending any changes to the use of Biaxin based on the study. The FDA said that previous studies of antibacterial drugs and Biaxin have not been associated with an increased risk of death. Biaxin is commonly used to treat bacterial respiratory infections. However, researchers have been studying whether Biaxin and similar drugs might prevent or treat heart disease.
The FDA said the Danish study "is the only time that an increase in deaths patients with heart disease was seen in patients who had taken clarithromycin."
The agency said it was not recommending any labeling changes for Biaxin and noted that Danish health authorities are also not making any new recommendations for use of Biaxin. The FDA said it put out an alert on Biaxin so that patients and physicians would be aware of the most recent study involving the drug.
Brian Kyhos, an Abbott spokesman, said the company believed the results of the Danish study were a "random" result and totally at odds with several other studies of Biaxin and other drugs in its class.
The FDA said it has reviewed analyses prepared by Abbott of Biaxin from studies the drug and those showed no significant differences in death rates or adverse events. But the agency said most of the studies only lasted for a few weeks or months and were not as long as the Danish study, which was conducted by researchers at the University of Copenhagen and is known as the Claricor study.
Researchers studied 4,373 patients who had a previous heart attack or other heart problem. Half of the patients received Biaxin, or clarithromycin, and the other half a placebo or fake pills for two weeks. The patients were then followed for an average of about three years. The study showed that there were 212 deaths in the Biaxin group and 172 in the placebo group. Most of the deaths were attributed to heart disease.
"The observed differences in deaths became apparent about one year or longer after the study drug was given," the FDA said in its alert to health-care professionals, which was an "unexpected finding."
The agency said there's no clear explanation for how clarithromycin would lead to more deaths than those in the placebo group or a biological explanation.
The FDA said it has not had access to the data from the Danish study to reach its own conclusion.
"As information becomes available from continued analysis of the Claricor study or other sources, appropriate further steps will be determined," the FDA said.
The Danish Medicines Agency said it conducted its own analysis of clarithromycin - available under three other brandnames in Denmark - and the mortality rate among a group of more than 50,000 patients older than age 40 who had been treated for ulcers with that and other antibiotics and found no differences in mortality rates.
Dr. John Teerlink, the director of the Heart Failure Clinic at the San Francisco VA, also said the Danish study appeared to be a "chance" finding and said it's unlikely that a two-week course of antibiotics would have an impact more than a year later. Teerlink is an Abbott consultant but he also serves on an outside panel of FDA medical experts that advises the FDA on cardiovascular drugs. He also noted that the class of antibiotics Biaxin belongs to has been around for than 50 years and there's been no evidence the products are linked to an increase in mortality.