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www.fdanews.com/articles/89878-fda-limits-use-strengthens-warnings-on-ketek-labeling

FDA LIMITS USE, STRENGTHENS WARNINGS ON KETEK LABELING

February 13, 2007

The FDA has followed a joint advisory committee's recommendations in removing two of three approved indications for Ketek and adding a black box warning to the antibiotic's labeling.

The agency removed the drug's approval to treat acute bacterial sinusitis and acute bacterial exacerbations of chronic bronchitis. These illnesses are "generally non-serious, and often self-limited," John Jenkins, director of CDER's Office of New Drugs, said.

Ketek, manufactured by sanofi-aventis, can now only be used to treat mild to moderate cases of community-acquired pneumonia, the agency said in its Feb. 12 announcement.

The product's new labeling will include a black box warning that patients with myasthenia gravis, a disease causing muscle weakness, should not use Ketek, the agency said. Ketek can exacerbate the effects of the disease, sometimes causing death, Jenkins said.

The agency also strengthened the warning section of the labeling for other adverse events and created a patient medication guide to inform patients of Ketek's potential risks. The product's warning for liver toxicity was strengthened last year.

A joint advisory committee recommended limiting the approved uses and strengthening the product warnings after questioning sanofi-aventis' use of non-inferiority trials in proving the drug's efficacy.

(http://www.fdanews.com/did/6_31/)