GPs have been being advised that valproate medicines typically used to treat epilepsy, bipolar disorder and migraines must not be prescribed to women who are pregnant.
The European Medicines Agency’s pharmacovigilance risk assessment committee has recommended restriction on the use of valproate medicines because of the ‘risk of malformations and developmental problems in children exposed to valproate in the womb.’
The committee also recommends that doctors who prescribe valproate provide women with full information to ensure that they understand the risks and to support their treatment decisions.
In a separate hearing, the committee said it had not found consistent evidence that the use of testosterone increases the risk of heart problems in its authorised indication in men who do not produce enough testosterone.
The committee considered the argument that the benefits of testosterone continue to outweigh the risks, but recommended that testosterone-containing medicines should only be used where lack of testosterone has been confirmed by signs and symptoms as well as laboratory tests.