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EMA Recommends Depakote Restrictions Over Pregnancy Risks

24 October 2014No Comments

depakote birth defectIn the midst of increasing concerns about the risk of birth defects from Depakote use in pregnancy, European drug safety experts have recommended that restrictions be placed on the use of Depakote for the treatment of bipolar disorder or epilepsy among women who are pregnant or who may become pregnant. The Pharmacovigilance and Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) issued the new recommendations on October 10, suggesting that more stringent restrictions be applied to Depakote’s active ingredient, valproate, due to the risk of birth defects among babies exposed to the controversial anticonvulsant drug during pregnancy.

Potential Side Effects of Depakote

“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 treatments are ineffective or not tolerated,” the EMA wrote as part of its new recommendations. “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.” In some countries, Depakote is also used as a treatment for chronic migraine headaches, and the PRAC also called for the same restrictions to apply in those cases.

Risk of Birth Defects from Depakote

The new EMA regulations regarding the prescription of Depakote among women of childbearing age is the result of a year-long review of the side effects of Depakote use in pregnancy. In the review, the PRAC found that 30% to 40% of children exposed to Depakote in pregnancy suffered from serious developmental problems like speech and language delays, lower IQ and problems with walking and talking. According to the PRAC review, babies born to women who took Depakote while pregnant also had an 11% chance of suffering from severe congenital malformations like cleft palate and neural tube birth defects.

Our Depakote Attorneys Can Help

Serious concerns have been raised in recent years about the safety of Depakote use in pregnancy, and in May 2013, the FDA elevated all valproate medications, including Depakote, from a pregnancy category D to a category X, but only for the treatment of migraines. For medications to be included in the X pregnancy category means that studies in humans or animals have demonstrated fetal abnormalities when exposed to the drug. In other words, category X means there is positive evidence of human fetal risk associated with the drug’s use in pregnancy. If you took Depakote while pregnant, and your child was born with a life-altering birth defect like spina bifida or a heart defect, contact our experienced Depakote lawyers at Bandas Law Firm today to discuss your legal options.



Posted Under: Drug Litigation