Ketek’s US prescribing information has been revised after discussion with the FDA to provide healthcare professionals and patients with updated information about adverse events reported in connection with the use of the product.
The revised prescribing information contains a bolded warning and additional information relating to the nature and characterization of hepatic events, as well as revised recommendations for the use of Ketek in patients with myasthenia gravis. These changes have been reviewed and agreed to by the FDA.
The antibiotic has been available in the US since 2004, and is estimated to have generated sales of $50 million in the first half of 2006.
Recently, Sanofi-Aventis voluntarily paused enrollment of its Ketek pediatric clinical trials to allow the company to confirm that the current program remains consistent with the FDA’s current thinking on the design of pediatric trials.