UPDATE 1-EU drug watchdog warns on use of Sanofi antibiotic
(Adds comment from company, sales, shares, background)
LONDON, March 30 (Reuters) - The European Medicines Agency said on Friday it was recommending restricted use and strengthened warnings for Sanofi-Aventis SA's (SASY.PA) antibiotic Ketek. The move follows similar restrictions announced by U.S. regulators last month.
Europe's drugs watchdog said the drug should not be used for treating bronchitis, sinusitis and tonsillitis unless infections were caused by bacterial strains resistant to other antibiotics.
Ketek remains suitable, however, for the treatment of community-acquired pneumonia without such restrictions, the London-based agency said.
The agency also said the drug was contraindicated for use by patients with myasthenia gravis, a disease that causes muscle weakness.
Sanofi, in a statement, said Ketek remained an important option in the anti-infective drug armoury, given the increasing rates of resistance to alternative macrolides and beta lactam antibiotics.
The latest warnings follow reports of severe liver damage and death in some Ketek patients that sparked a debate over the drug's safety. Ketek, known generically as telithromycin, already comes with a warning for possible liver damage.
Shares of Paris-based Sanofi were 0.9 percent lower at 64.45 euros by 1000 GMT, underperforming a European drugs sector .SXDP that lost 0.3 percent.
Ketek had sales of 155 million euros ($206.8 million) in 2006 and is currently marketed in more than 50 countries.
((Reporting by Ben Hirschler, editing by Quentin Bryar; email: ben.hirschler@reuters.com; Reuters Messaging: ben.hirschler.reuters.com@reuters.net; +44 20 7542 5082))
($1=.7495 Euro) Keywords: SANOFI KETEK/
(C) Reuters 2007. All rights reserved. Republication or redistribution ofReuters content, including by caching, framing or similar means, is expresslyprohibited without the prior written consent of Reuters. Reuters and the Reuterssphere logo are registered trademarks and trademarks of the Reuters group ofcompanies around the world.nL30254455
