FDA Urges Doctors to Weigh Risks when Prescribing Depakote to Women According to CJF

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New information about Depakote pregnancy risks has led the FDA to urge healthcare professionals to carefully weigh all benefits and risks of Depakote treatment before prescribing the drug to women of childbearing age. Depakote is one of the most commonly prescribed anticonvulsant medications, used in the treatment of epilepsy, seizures, migraine headaches and bipolar disorder. For more information about potential Depakote birth defects or to contact a Depakote attorney, visit http://www.DepakoteBirthInjury.com, a free online resource provided by the Consumer Justice Foundation and intended to help American consumers injured by pharmaceutical drugs.

The FDA recently issued a safety announcement urging physicians to consider all benefits and risks of Depakote treatment before prescribing Depakote to women of childbearing age, especially for conditions not typically associated with permanent injury or death (fda.gov/Drugs/DrugSafety/ucm261543.htm). This FDA action was taken in response to new data (Cognitive function at 3 years of age after fetal exposure to antiepileptic drugs, N Engl J Med 2009) regarding the increased risk of lower cognitive test scores in children whose mothers take Depakote during pregnancy. According to the results of epidemiologic studies, children born to women who took valproic acid (Depakote) throughout pregnancy tended to score lower on cognitive tests, compared to children whose mothers received no anticonvulsant while pregnant (fda.gov/Drugs/DrugSafety/ucm261543.htm).

Depakote belongs to a class of prescription drugs called anticonvulsants, and is commonly prescribed to patients suffering from epilepsy, migraine headaches, seizures, or the manic phase of bipolar disorder. Depakote (valproic acid) is manufactured by pharmaceutical company Abbott Laboratories, and functions by inhibiting the firing of certain neurotransmitters in the brain which are responsible for causing seizure-related episodes. Depakote has been on the market since 1983 and has since become one of the most frequently prescribed anticonvulsant drugs on the U.S. market.

Previous FDA warnings have alerted patients and healthcare providers about the teratogenicity of Depakote, or the drug's potential to interrupt fetal development and cause congenital birth defects (fda.gov). The 2009 FDA notice centered around potential Depakote birth defects like neural tube defects, heart defects and craniofacial birth defects (fda.gov). In 2001, the New England Journal of Medicine published a study in which researchers concluded that anticonvulsant drugs like Depakote are one of the most common causes of potential harm to a fetus in utero (“The Teratogenicity of Anticonvulsant Drugs,” nejm.org).

The FDA has classified Depakote as a pregnancy category D medication, which means there is positive human evidence of the drug's potential to cause significant harm to a fetus when taken during pregnancy. In light of new data highlighting additional pregnancy risks associated with Depakote (fda.gov/Drugs/DrugSafety/ucm261543.htm), the FDA has advised healthcare professionals to consider alternative medications that have a lower risk of birth defects for pregnant women or women of childbearing age. According to the FDA, Depakote should only be prescribed to these patients if the possible benefits of the treatment outweigh the potential risks to the fetus (fda.gov/Drugs/DrugSafety/ucm261543.htm).

Many birth defects occur during the first trimester of pregnancy, before many women even know they are pregnant. Because nearly half of all pregnancies are unplanned, all women of childbearing age taking Depakote may be at risk of unknowingly causing severe harm to their unborn child. For women who took Depakote during pregnancy and gave birth to a child with one or more birth defects, legal help is available. The Consumer Justice Foundation has developed an online resource through http://www.DepakoteBirthInjury.com to provide American consumers with access to experienced Depakote attorneys and critical information about potential Depakote birth defects.

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Faith Anderson
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