The antibiotic Ketek, linked to reports of severe liver problems, including several deaths, will be subjected to new scrutiny by U.S. health advisers, according to a federal notice. Meanwhile, the Senate Finance Committee is investigating allegations of fraud connected with trials of Ketek, or telithromycin, as well as how the FDA has handled relevant safety issues. Through April, the FDA received at least a dozen reports of acute liver failure, including four deaths, among patients treated with Ketek.
November 15, 2006 at 12:00 AM
1 minute read
The original version of this story was published on Law.Com
A novel antibiotic linked to rare reports of severe liver problems, including several deaths, will be subjected to new scrutiny by federal health advisers, according to a document released this week.
The Food and Drug Administration has asked a joint panel of outside experts to discuss the overall risks and benefits of the antibiotic Ketek during a Dec. 14-15 meeting, according to a federal notice.
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