Hepatitis News

Antibiotic Ketek May Cause Liver Damage, Warning Label Requested

At a glance:

The FDA has requested that drugmaker Sanofi-Aventis apply a strong warning label to its antibiotic Ketek. 
 
The drug, approved in the U.S. in 2004, is used to treat infections such as bronchitis and pneumonia and has been implicated in 12 cases of liver failure including 4 deaths. 
 
Furthermore, the incidence of liver complications observed in the U.S. is higher than that reported in Europe, where the drug has been in use since 2001. 
 
An investigation of circumstances surrounding the drug's approval is underway.


FDA Wants Warning on Ketek

Red Herring - 5/19/2006 10:39 AM

The U.S. Food and Drug Administration has sent a memo to Sanofi-Aventis asking the French drugmaker to put a strongly worded warning label on its antibiotic Ketek after finding 12 cases of liver failure, including four fatalities, according to reports Friday.
 
Safety regulators from the FDA’s Division of Drug Risk Evaluation identified cases of liver injury that set in just a few days after patients began taking the drug, according to The Wall Street Journal. The drug was linked to four fatalities

 
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