ARTICLE | Company News

Ketek warnings strengthened

June 30, 2006 12:36 AM UTC

FDA and sanofi-aventis (Euronext:SAN; SNY) strengthened warnings about rare liver toxicity on the label for Ketek telithromycin based on an assessment of adverse event reports. The statement about hepatotoxicity has been upgraded from a caution to a bolded warning, and information has been added about the potential for Ketek to cause deaths in patients with myasthenia gravis, a neurological condition that can be exacerbated by antibiotics.

FDA said it has verified reports of four deaths from acute liver toxicity associated with Ketek between its approval in April 2004 and April 2006. The agency has verified 23 cases of serious liver toxicity out of 10 million prescriptions. ...