FDA ISSUES ALERT ON BIAXIN
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.
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