* FDA warns about drug promotions without safety info
* Demands written responses by April 9 (Adds Glaxo material, Biogen comment, byline)
By Bill Berkrot
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.
British drugmaker GlaxoSmithKline (GSK.L) received a similar warning letter about sponsored links on search engines for several of its medicines that include efficacy claims but fail to include any safety risk information.
The Glaxo medicines cited were diabetes drugs Avandia, Avandamet and Avandaryl, the blood pressure medicine Coreg, Avodart for enlarged prostate and the breast cancer drug Tykerb. Glaxo was also told to cease offending practices and respond to the charges in writing by April 9.
"We take our responsibility to communicate appropriately about the risks and benefits of our products seriously," said a Biogen spokeswoman. "We are working with FDA closely to resolve this situation."
The other two drugmakers were not immediately available to respond to calls seeking comment.
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.
The FDA's warning over Plavix promotional links was nearly identical, saying the sponsored links failed to communicate any risk information associated with the drug.
"By omitting the most serious and frequently occurring risks associated with Plavix, the sponsored links misleadingly suggest that Plavix is safer than has been demonstrated," the letter to Sanofi said.
Plavix, used to prevent blood clots that can cause heart attacks and strokes in patients who have undergone artery-clearing procedures, increases the risk of serious bleeding.
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 Gary Hill)
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