The antiobiotic "Ketek," made by Sanofi-Aventis, must now carry a bold-type warning about reports of liver failure and severe injury, some of them fatal, in patients treated with the drug.
The Food and Drug Administration approved Ketek in 2004. It is used to treat respiratory tract infections, bronchitis, sinusitis and community-acquired pneumonia. Through April, the FDA has received reports of 12 cases of acute liver failure, including four deaths, among people treated with Ketek. A fifth required a liver transplant.
"In certain of these cases, it appears there are no other likely causes of liver injury, so it does appear they were linked to the use of the drug," said Dr. John Jenkins, director of the Office of New Drugs in the FDA's Center for Drug Evaluation and Research.
Despite this evidence, both the FDA and Sanofi-Aventis believe the drug's benefits still outweigh its risks.
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