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Court action over sodium valproate

GPs have been advised to take extra caution over the use of sodium valproate in women of childbearing age after a major court case began against the drug's manufacturer.

A group of women are suing Sanofi-Synthelabo using consumer protection legislation, after claiming sodium valproate taken during pregnancy caused fetal anticonvulsant syndrome (FACS) in their children.

The Medical Defence Union said that although the class action should not affect GPs, mothers could pursue individual prescribers if the claim against the company was unsuccessful.

Irwin Mitchell, the law firm handling the mothers' claims, said: 'We think it is possible to say that these anticonvulsant drugs are defective because

the epileptic mother who is pregnant faces an impossible dilemma.

'Either she takes the drugs while pregnant and runs the risks of FACS known to be associated with them, or gives up anticonvulsant drugs before conceiving and during pregnancy and runs the risk of seizures and/or status epilepticus, which may themselves harm herself and the baby.'

Dr Brian Crichton, RCGP prescribing adviser and a GP in Solihull, said the case showed again the importance of making sure patients of childbearing age were properly informed, and fully documenting any advice that had been given.

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