MONDAY, Feb. 12, 2007 (HealthDay News) -- The U.S. Food and Drug Administration announced Monday that the controversial antibiotic Ketek, which has been linked to liver damage, will now come with a "black box" warning when prescribed to treat pneumonia.
And the drug will no longer be approved to treat two "lesser indications," sinusitis and bronchitis.
The revisions mirror recommendations made by two FDA advisory committees last year.
"The changes are designed to inform health-care providers and patients regarding the safe and effective use of Ketek consistent with advice received from advisory committees in December of last year," Dr. John Jenkins director of the Office of New Drugs at the FDA's Center for Drug Evaluation and Research, told reporters at a teleconference. "The changes are the result of a comprehensive analysis of available data regarding the benefits and risks of Ketek conducted by [FDA] team members."
Ketek (generic name telithromycin) is getting the black-box warning, the strongest available, stating that it should not be used in patients with myasthenia gravis, a neurolmuscular autoimmune disease that causes muscle weakness. The new labeling will also include a strengthened warning on specific adverse events, such as visual disturbances and loss of consciousness.
A patient medication guide using "patient-friendly" language will also be passed out with each new prescription.
As recommended by the advisory committees, the antibiotic will no longer be approved for sinusitis and bronchitis.
"The benefits and risks do not support continued approval for Ketek for these often non-serious and self-limited illnesses," Jenkins said. "The drug continues to be approved for community-acquired pneumonia of mild to moderate severity, which is a more serious illness that generally does not resolve without antibiotic therapy."
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.
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
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