Sunday, May 11

FDA warns on Tysabri, Plavix promotional links

NEW YORK, April 3 (Reuters) - The U.S. Food and Drug Administration sent warning letters to Biogen Idec Inc (BIIB.O) and Sanofi-Aventis (SASY.PA) about sponsored links on Internet search engines for their most important drugs that fail to provide required safety information.

The letters involve Biogen's multiple sclerosis drug Tysabri and the multibillion-dollar blood clot preventer Plavix that Sanofi sells along with Bristol-Myers Squibb Co (BMY.N).

In separate letters posted on the FDA Website on Friday, Biogen and Sanofi were ordered to rectify the problems cited regarding promotional material and to submit a written response by April 9 stating whether they intend to comply.

The letter to Biogen dated March 26 says sponsored links for Tysabri that pop up on search engines such as Google "make representations and/or suggestions about the efficacy of Tysabri, but fail to communicate any risk information associated with the use of this product."

The FDA said "the sponsored links misleadingly suggest that Tysabri is safer than it is known to be."

Tysabri, sold in partnership with Irish drugmaker Elan Corp (ELN.I), has been linked to cases of a potentially fatal brain infection called progressive multifocal leukoencephalopathy, or PML, and is available only through a restricted distribution program.

France-based Sanofi was further urged by the FDA to review promotional materials for other prescription drugs it sells in the United States "and to discontinue or revise any materials with the same or similar violations." (Reporting by Bill Berkrot, editing by Leslie Gevirtz).....story from Reuters