FDA Advisers Recommend Limits for Ketek Antibiotic

ROCKVILLE, Md., Dec. 15 -- Two FDA advisory committees agreed today that the antibiotic Ketek (telithromycin) should be limited to second-line therapy for community-acquired pneumonia, and that the drug should have black box warning added to its label.

Ketek, which is made by Sanofi-Aventis, is approved for acute bacterial bronchitis and acute bacterial sinusitis as well as for community-acquired pneumonia.

John Jenkins, M.D., director of the FDA's office of new drugs, who spoke at press briefing at the close of the two-day session of the joint committees, said that 16 advisers agreed that the drug had demonstrated benefit for treatment of community-acquired pneumonia, but only two advisers felt that Ketek's benefits outweighed its risks for treatment of bronchitis and sinusitis.

In June the FDA changed the drug's label to add a warning about hepatoxicity following four reported deaths and one live transplant.

On Thursday and Friday, the panel reviewed information that linked the drug to hepatoxicity, blurring of vision, loss of consciousness, and exacerbation of myasthenia gravis.

When Ketek was approved in 2004, the FDA approved drugs on the basis of non-inferiority trials, which was one of the problems facing the advisory panel members. Dr. Jenkins said those clinical data did not contain enough information to confirm that Ketek is effective for either bronchitis or sinusitis.

John Edwards, M.D., acting chair of the FDA's anti-infective drugs advisory committee, said panel members had not been asked to consider the possibility of adding a black box to the Ketek label. But during their deliberations 13 panel members indicated they favored adding a black box warning.