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June 22, 2009

US FDA staff urge review of Abbott drug risks

Quoted from http://www.reuters.com/article/marketsNews/idINN1943894220090619?rpc=44

US FDA staff urge review of Abbott drug risks

Fri Jun 19, 2009 11:21am EDT

By Lisa Richwine

WASHINGTON, June 19 (Reuters) - U.S. drug reviewers have recommended additional study of delayed development reported in children of mothers who took Abbott Laboratories' (ABT.N) anti-seizure drug Depakote.

Six cases received since its approval in 1983, including two siblings reported to have autism, "raise concerns," Food and Drug Administration staff wrote in a May 6 memo released on Friday.

Limitations in the reports "make it impossible to definitively conclude" the drug played a role, and genetics or other factors may have contributed, especially in the two sibling cases of autism, the FDA reviewers said.

[Article continues at original source]

Posted at 08:28 AM in Depakote |

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