FDAnews Drug Daily Bulletin


Dec. 20, 2005

The FDA has issued a public health advisory to alert patients and healthcare professionals about recent clinical data that suggests Abbott's antibiotic Biaxin may be associated with heart problems.

The alert draws attention to a Danish study that showed increased mortality in patients treated with Biaxin (clarithromycin), compared with patients who received a placebo. The observed difference in mortality became apparent after patients had been followed for one year or longer after the study drug was given, the FDA said. The CLARICOR trial was published in the Dec. 8 edition of the British Medical Journal.

However, despite the study results, the FDA said it is not recommending any specific changes to the usage recommendations or labeling for Biaxin. The agency noted that previous trials of antibacterial drugs to prevent heart disease and other trials of clarithromycin have not shown a statistically significant effect on mortality. The Danish study "is the only time that an increase in deaths in patients with heart disease was seen in patients who had taken clarithromycin," the FDA said.

The FDA noted it has discussed the CLARICOR findings with the Danish Medicines Agency, which also elected not to change its recommendations for Biaxin.

For more information, go to http://www.fda.gov/cder/drug/infopage/clarithromycin/default.htm.