The MHRA has urged healthcare professionals to give “better information” to women about the risks of taking valproate during pregnancy.

The medicines watchdog had strengthened the product information for the drug, used to treat epilepsy and bipolar disorder, to ensure patients were aware of the risk of developmental problems in children exposed to it in the womb, it said yesterday (January 21).

The MHRA’s decision follows a review of the drug by European regulator the Coordination Group for Mutual Recognition and Decentralised Procedures last year, which showed that valproate could cause developmental problems in up to 40 per cent of unborn children.

The risks

The European Medicines Agency (EMA) said these problems included delayed walking and talking, memory problems, lower intellectual ability, and difficulty with speech and language. Children exposed to valproate also had an 11 per cent risk of malformations at birth, such as neural tube defects or a cleft palate, compared with a 2-3 per cent risk among the general population, the EMA said at the time.

The MHRA said this review had helped to “better quantify and describe” the risk of developmental disorders. As well as updating the leaflet included in the medicine's packaging, the MHRA would make information booklets available as educational tools for healthcare professionals and patients, it said.

The risk of birth defects in unborn children exposed to the drug had been included in information for patients and prescribers for “several years”, the MHRA stressed. 

MHRA director of vigilance and risk management of medicines Jane Raine said woman of childbearing age should be given contraception if valproate was their only effective treatment option.

“Women taking valproate must have regular reviews of their treatment. However, it is important that no one should stop taking valproate without discussing it with their doctor first,” she added.
 

What could pharmacists do to improve awareness of the risks?

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