Research links epilepsy drug to autism

LONDON, Dec 1 (Reuters) - Pregnant women taking the Sanofi-Aventis (SASY.PA) epilepsy pill Epilim may raise their child's risk of developing autism, British researchers said on Monday.

Their study published in the journal Neurology showed children whose mothers took Epilim during pregnancy were seven times more likely to develop the condition compared with babies whose mothers did not take an epilepsy drug.

The preliminary findings on the drug, known generically as valproate and sold as Depakine in the United States by Abbott Laboratories (ABT.N), bolster previous research linking the drug to problems during pregnancy.

But a researcher not involved in the study cautioned the link to autism was preliminary and said women should consult their doctors if they are concerned, noting seizures during pregnancy can endanger both mother and fetus.

"It raises a question that should be pursued," Michael Goldstein, a vice president of the American Academy of Neurology who practices at Western Neurological Associates in Salt Lake City said in a telephone interview.

"Women should not panic but instead talk to their neurologist before becoming pregnant to determine whether medicine is needed and what the best medicine is."

Other studies have shown that the drug is more likely to cause birth defects than other epilepsy drugs, the researchers said.

Sanofi spokeswoman Jennifer Wilson said the drugmaker welcomed the preliminary results from the study it partially funded and was committed to improving treatments for women with epilepsy, particularly during pregnancy.

The company also agreed with the researchers acknowledgements of the study's limitations, including the relatively small sample size for each of the groups. Gus Baker and colleagues at the Liverpool and Manchester Neurodevelopment Group looked at 632 children, about half of whom were exposed to epilepsy drugs while in the womb.

Of the children whose pregnant mothers took an epilepsy drug, 64 were exposed to Epilim, 44 to GlaxoSmithKline Plc's (GSK.L) Lamictal, 76 to Novartis AG's (NOVN.VX) Tegretol and 65 to other epilepsy treatments.

Tests at one, three and six years of age showed that nine children had developed autism, and another showed signs of the disorder whose symptoms range from severe social avoidance to repetitive behaviours and sometimes mental retardation.

Seven of the autistic children had mothers who took an epilepsy drug while pregnant, including four on Epilim and another on a combination of the Sanofi drug and Lamictal, the researchers said.

None of the children in the study had a known family history of autism and the raised risk for the mysterious condition was not seen with the other epilepsy drugs, the researchers said.

No one knows what causes the disorder affecting about 1 in 150 children but doctors agree there is a genetic component. They also theorize that something in the environment -- and possibly conditions in the womb -- can trigger the condition. (Reporting by Michael Kahn; Editing by Maggie Fox and Jon Loades-Carter)