Strengthened Depakote Pregnancy Warnings - Consumer Justice Foundation

Strengthened Depakote Pregnancy Warnings

Written by Faith Anderson on May 8, 2013
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Birth Defects Possibly Linked to Depakote

Depakote was approved for use as an epilepsy treatment in the United States in 1978, and has since become one of the most widely used anticonvulsant medications in the country. Unfortunately, mounting research has identified Depakote use during pregnancy as a potential risk factor for devastating side effects, including the development of birth defects among children exposed to the drug in utero. Additional studies published in recent years have identified a possible link between Depakote use in pregnancy and lower scores on I.Q. tests among exposed children.

FDA Issues Depakote “Black Box” Warning

In 2006, the FDA added a “black box” warning to the Depakote label, warning consumers and the medical community about the risk of birth defects associated with the medication. This warning came after a study found that 20% of mothers who took Depakote while pregnant gave birth to children with birth defects or congenital malformations. Earlier this year, a study published in the Journal of Neurology, Neurosurgery and Psychiatry indicated that children born to women who took Depakote during pregnancy had an increased risk of experiencing serious developmental delays, including autism and lower I.Q.

Depakote Classified as Class “X” Pregnancy Drug

After analyzing available data regarding Depakote and the associated pregnancy risks, the FDA re-classified Depakote and all other valproate-based medications from class “D” to class “X” pregnancy drugs, but only when used to treat migraines. For all other indications, Depakote remains a pregnancy category D medication, which means there is positive human evidence suggesting the drug may interfere with fetal development and cause devastating Depakote birth defects. Among the birth defects possibly linked to Depakote use in pregnancy are spina bifida, skull malformations, cleft palate, heart defects, and urinary tract problems.

Contact an Experienced Attorney to File a Claim

Although the FDA has not gone so far as to contraindicate Depakote use during pregnancy altogether, the agency did contraindicate use of the drug among pregnant women suffering from migraines, suggesting that the risks of the treatment outweigh any possible benefits. In addition to Depakote and Depacon, other medications affected by the new warning include Depakene, Stavzor and their generic equivalents. If your child has suffered a birth defect or a developmental delay, and you believe the anticonvulsant Depakote to be the cause, our consumer advocates at the Consumer Justice Foundation can help you contact a reputable lawyer with experience handling defective drug cases in your area. With an experienced attorney on your side, you may be able to pursue financial compensation for your child’s injuries and medical expenses.

Source: http://www.fda.gov/Drugs/DrugSafety/ucm350684.htm

Posted Under: FDA - Food and Drug Administration
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