EMA Recommends Restrictions in Light of Depakote Birth Defect Risks

Restrictions on Depakote Use

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EMA Recommends Restrictions in Light of Depakote Birth Defect Risks

A review of the potential risk of Depakote birth defects has resulted in new recommendations from European regulators regarding the use of Depakote in pregnancy.

Amid increasing concerns about the risk of birth defects from Depakote use in pregnancy, European drug safety officials have issued a notice indicating that restrictions should be placed on the use of Depakote among women who are pregnant or who may become pregnant. The European Medicine Agency’s (EMA) Pharmacovigilance and Risk Assessment Committee (PRAC) issued new recommendations on October 10, calling for more stringent restrictions on valproate, the active ingredient in Depakote, due to the potential for the anticonvulsant drug to cause fetal malformations among children exposed to the medication in utero. If your child was born with a serious birth defect and you believe Depakote to be the cause, contact an experienced Depakote lawyer today for legal help.

Risks of Depakote Use in Pregnancy

Depakote is an anticonvulsant drug manufactured by Abbott Laboratories and commonly used to treat epilepsy and bipolar disorder. These new recommendations by the EMA come in the midst of a growing body of research identifying a host of birth defects potentially associated with Depakote use during pregnancy. “Valproate should not be used to treat epilepsy or bipolar disorder in girls and in women who are pregnant or who can become pregnant unless other treatment asre ineffective or not tolerated,” the EMA report states. “Women for whom valproate is the only option after trying other treatments, should use effective contraception and treatment should be started and supervised by a doctor experienced in treating these conditions.”

Potential Depakote Birth Defects

In addition to treating epilepsy and bipolar disorder, Depakote is also used in some countries as a treatment for migraine headaches, and the EMA report calls for the same restrictions for that particular indication. The new Depakote recommendations were issued by drug safety officials following a year-long review of the potential side effects of Depakote use in pregnancy. According to their findings, 30% to 40% of children exposed to Depakote in utero suffered developmental problems like lower IQ, speech and language problems, and developmental delays, and 11% of children suffered devastating birth defects like cleft palate and neural tube malformations.

Depakote Pregnancy Category X

Although the European Medicine Agency has just now issued a warning about the pregnancy risks associated with Depakote, researchers have been exploring the potential link between Depakote use in pregnancy and severe birth defects for years. In 2006, the FDA added a “black box” warning to the Depakote label, warning users about the risk of congenital malformations after a study found that 20% of pregnant women who gave birth while taking Depakote had a child with birth defects. In May 2013, the FDA elevated the pregnancy category of Depakote from D to X, warning that the anticonvulsant drug is not appropriate for the treatment of migraine headaches in pregnant women.

Contact an Experienced Depakote Lawyer for Help

Depakote maker Abbott Laboratories currently faces a growing number of Depakote lawsuits filed on behalf of families who believe their children have been adversely affected by birth defects from Depakote. All of the complaints involve similar allegations that the drug company failed to adequately research the anticonvulsant drug, or warn consumers about the risks of becoming pregnant while taking Depakote. If you believe your child has suffered alleged Depakote birth defects, our consumer advocates at the Consumer Justice Foundation can help. We are committed to protecting the rights of consumers harmed by dangerous medications, and can help put you in touch with a reputable attorney who has experience handling Depakote birth defect claims.
[box type=”note” align=”aligncenter” ]Source: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2014/10/news_detail_002186.jsp&mid=WC0b01ac058004d5c1[/box]

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