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Page: << Prev | 1 | 2 Ketek is manufactured by Sanofi-Aventis. But since its approval in 2004, hundreds of cases of liver damage, loss of consciousness and other side effects have been reported. According to the Wall Street Journal, U.S. doctors wrote more than 3.35 million prescriptions for the antibiotic in 2005.
The drug and the related approval process have been dogged by criticism, however. Last June, Sanofi-Aventis agreed to update Ketek's labeling to reflect the possibility of severe liver damage. And last month, a European Medicines Agency panel recommended that Ketek not be given to patients with a history of such liver conditions as hepatitis or jaundice.
The label changes announced Monday by the FDA come as a U.S. House of Representatives subcommittee is preparing to open a hearing on drug safety that will examine irregularities in the approval of Ketek. The FDA's handling of the antibiotic remains under investigation by the Senate as well, the Associated Press reported.
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During the December hearings, the FDA was forced to defend its use of post-marketing data from Europe to approve the drug.
The U.S. Senate Finance Committee is also investigating allegations of fraud involving clinical trials of Ketek and is looking into how the FDA handled Ketek-related safety issues, Bloomberg News reported.
Sen. Charles Grassley, an Iowa Republican, has accused the FDA of withholding relevant information at the time of the drug's approval.
The joint FDA panel that met in December consisted of the agency's Anti-Infective Drugs and Drug Safety and Risk Management Advisory committees.
The panel voted 16-3 that the benefits of Ketek outweighed the risks for community-acquired pneumonia, and 13-5 in favor of a black box warning.
The panel also voted 17-2 that Ketek's benefits for patients with sinusitis and bronchitis did not outweigh the risks of the drug.
More information
To learn more, visit the FDA.
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