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Side-effects risks of epilepsy drugs not made clear to women

18 June, 2001

Information about the potential for birth defects if anti-epileptic drugs are taken during pregnancy is not being given to women, according to a report in Health Which?

Specialists agree that seizures pose more risks for pregnant woman than antiepileptic drugs and that women should continue to take their medication. However, clearer information, and specialist pre-conception counselling – which has been shown to substantially reduce the risk of birth defects – should be made available to all women.

Despite under-reporting of side-effect data via the yellow card scheme, the Medicines Control Agency (MCA) has received hundreds of reports about malformations with a suspected link to antiepileptic drugs. Nearly 400 have been associated with valproate, and more than 100 each for phenytoin and carbamazepine. But patient information leaflets included with the drugs often do not hold information about such side-effects. That's despite the fact that the MCA told Health Which? that patient information leaflets should be 'very similar' to more detailed information (summary of product characteristics) provided to doctors.

Health Which? has highlighted several instances where patient information leaflets are missing crucial information that is included in summary of product characteristics. For instance, the patient information leaflets for the drugs Tegretol, Lamictal, Sabril and Neurontin fail to mention any of the risks affecting foetal development and merely say that women who become pregnant, or are considering pregnancy, should seek advice from a doctor.

The magazine also highlights growing concerns that antiepileptic drugs may be linked with developmental problems in children of mothers who took the drugs while pregnant. While the link is currently controversial, results from preliminary studies suggest more research is needed.

Sue Freeman, Managing Editor of Health Which?, said:

"It's vital that women continue to take their medication. However they face a lack of information about the potential effects of these drugs should they become pregnant. "Manufacturers must provide clear advice on the risks associated with pregnancy and women should have access to specialist pre-conception counselling. Experts we've spoken to point to research which has found a relative lack of awareness among GPs about these potential side-effects."