> Valproate in pregnancy

because of the risk of malformations and development problems in children exposed to valproate, during pregnancy.

the Committee recommends that The valproate is used to treat epilepsy or bipolar disorder in girls and women who are pregnant or who may become pregnant unless other treatments are ineffective or not tolerated.

Adds that women for whom valproate is the only option, they should use a contraception effective and that a doctor experienced in treating these conditions should start and supervise treatment.

The warning also applies to the use of valproate for the prevention of migraine headaches.

The Committee EMA has also recommended that doctors who prescribe valproate provide women full information to ensure understanding of the risks and to support their decisions.

These recommendations are a result of an analysis of the available data on the effects of exposure to valproate during pregnancy. During the analysis, the Committee also consulted representatives of patients and families who have been affected, così as a group of experts and specialists.

While valproate remains an option for patients where other treatments have failed or are not tolerated, the Committee concluded that women and healthcare professionals need to be better informed about the risks of exposure to valproate in utero, and the needà of effective contraception.

High percentage of the problems of development

recent Studies have shown that children in età pre-school exposed to valproate during pregnancy have up to 30 to 40% risk for developmental problems, including delays in walking and talking, memory problems, difficulty with language and language and child ability; intellectual, explains the declaration by the EMA.

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in Addition, the data show that children exposed to valproate in the womb are approximately 11% of the risk for birth defects (such as neural tube defects, and cleft palate) in comparison to the risk by 2 to 3% among children in the general population. The available data also suggest that children exposed to valproate during pregnancy have a three fold higher risk for a spectrum disorder of autism and a risk five times greater for autism in children.

limited Data also indicate that children exposed to valproate in the womb may have più the possibilityà to develop symptoms of the disorder of attention-deficit/adhd)à.

The Committee recommended that materials that are educational should be provided to all healthcare professionals in the EU and to women, which has been prescribed valproate to inform them of these risks. You askà to the doctors of the regular analysis of the treatment of girls and women, including the pubertà and when a woman plans on becoming pregnant.

The Committee’s recommendations will now be sent to the Group co-ordinate for Mutual Recognition Procedures and Decentralised – Human, which will adoptà a final position. In the meantime, women currently taking valproate who have questions about their treatment should talk with their doctors, says the EMA.

The analysis of valproate is started in October 2013 after the publication of new data on the risks of exposure to valproate in the womb.

Recommendation Supported

Commenting on the recommendation for Medscape Medical News, Stacey Rennard, public relations, and manager of campaigns for the support group Epilepsy Action Uk, said that the organization supports the recommendation that sodium valproate should not be first-line treatment for epilepsy in women with potential childbearing or in girls who will need treatment in their fertile years.

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“We also agree that women need to be better informed about the risks of the medication during pregnancy. In recent years we have done campaigns becauseé the women in età fertile with epilepsy should receive counseling preconcezionale to be sure that they are made aware of the risks associated with drugs for epilepsy. We have also produced resources to support women with epilepsy in età fertile,” said Rennard.

While other drugs for epilepsy are available, Epilepsy Action stresses that for some women who are pregnant or who may become pregnant, sodium valproate, più low effective dose is the drug più suitable to use.

“This canò happen becauseé alternative drugs lacking in giving control of the attack, cause significant side effects, or the risk of uncontrolled seizures outweighs the risks associated with sodium valproate. In this case, after having discussed all the risks and benefits, the patient and the physician may decide that medication is the option più safe for them,” added Rennard.

“If adopted, the recommendations should help to ensure that women are aware of the risks of sodium valproate and, together with the health care professionals, are able to make informed decisions about their care,” adds Epilepsy Action.


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17 October 2014