The European Medicines Agency has asked Sanofi-Aventis to include stronger warnings on its antibiotic product Ketek after reviewing cases of serious liver injury associated with its use.
The EMEA described the move as a ‘precautionary measure,' to be undertaken while it carries out a full risk/benefit analysis of the product as part of an ongoing renewal procedure for Ketek's (telithromycin) marketing authorisation in the European Union. Labelling for the drug already mentions a risk of liver toxicity.
The EMEA’s action follows a similar probe by the US Food and Drug Administration, which said earlier this month it is examining whether to ask for new labelling for Ketek after three cases of liver toxicity were reported on Annals of Internal Medicine website on January 20.
Ketek had third-quarter 2005 sales of 38 million euros ($47m), 7.3% lower than in the same period of 2004. Sanofi-Aventis reported its fourth-quarter figures today, but did not publish Ketek revenues.