The labeling for the antibiotic Ketek (telithromycin) will be updated to reflect the possibility of severe liver damage, manufacturer Sanofi-Aventis said Thursday.
July 1, 2006 (Press Release) --
The labeling for the antibiotic Ketek (telithromycin) will be updated to reflect the possibility of severe liver damage, manufacturer Sanofi-Aventis said Thursday.
The U.S. Food and Drug Administration has received 12 reports of acute liver failure, four of which were fatal, the Associated Press reported. FDA safety evaluators found 23 other cases of serious liver injury among Ketek users, the wire service said.
An internal FDA memo says those injury reports, in proportion to the number of prescriptions written, exceed adverse reports for similar drugs, the AP said.
The drug has been sold in the United States since 2004. Earlier this month, Sanofi stopped enrolling children in trials of Ketek, the wire service said.
The Senate Finance Committee is investigating allegations of fraud connected with the Ketek trials, the AP reported, without elaborating.
Source: http://www.msn.com/
The U.S. Food and Drug Administration has received 12 reports of acute liver failure, four of which were fatal, the Associated Press reported. FDA safety evaluators found 23 other cases of serious liver injury among Ketek users, the wire service said.
An internal FDA memo says those injury reports, in proportion to the number of prescriptions written, exceed adverse reports for similar drugs, the AP said.
The drug has been sold in the United States since 2004. Earlier this month, Sanofi stopped enrolling children in trials of Ketek, the wire service said.
The Senate Finance Committee is investigating allegations of fraud connected with the Ketek trials, the AP reported, without elaborating.
Source: http://www.msn.com/
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