FDA Warns Increased Risk of Birth Defects in Babies Exposed to Valproate Sodium During Pregnancy

Dec. 1, 2010 - PRLog -- FDA has officially notified health care professionals and patients about the increased risk of major birth defects and birth injuries in babies exposed to valproate sodium, and the related product Depakote, during pregnancy.  Valproate sodium is manufactured by Abbot Laboratories under the name Depakote and is used to treat severe migraines, epilepsy, manic bipolar episodes and other seizure disorders.

Valproate sodium products are marketed under the following brand names:
•   Depacon (valproate sodium)
•   Depakote, Depakote CP, Depakote ER, Depakote Sprinkles (dilvalproex sodium)
•   Depakene (valproic acid)
•   Stavzor (valproic acid)

Depakote has been approved for use in the United States several times by the FDA, this first of which was in 1983 for the treatment of epilepsy. In May of 1995, Depakote was approved for use in treatment of the manic phase of bipolar disorder.  Less than one year later, Depakote was approved for use in the reduction of the number of migraine headaches suffered by patients.  Finally, in December of 2002, the FDA approved the use of Depakote ER for use as an adjunctive therapy for adults with epileptic seizures. Depakote has also been used for a variety of off-label treatments, including the treatment of schizophrenia.

The FDA warning centers around the risk of neural tube defects (defects of the brain and spinal cord) and other major birth defects, such as craniofacial defects (clef palate or abnormally formed face and skull) and cardiovascular malformations (abnormally formed heart or blood vessels) in babies exposed to valproate sodium and related products during pregnancy.

Patients are advised to consult the medication guide for valproate that is provided with each prescription and describes in detail the benefits and risks of valproate sodium and encourages patients to dis-cuss option with their health care provider.

FDA Guidelines and Recommendations for Depakote use:
•   Women who are planning a pregnancy or who become pregnant while taking valproate sodium or Depakote should contact their health care professionals immediately.
•   Valproate should not be stopped without talking to a health care professional, even in preg-nant women. Stopping valproate suddenly can cause serious problems.
•   Women who may bear children should only use valproate if it is necessary to manage their medical condition. Talk to your health care professional about the risks and options should you use a valproate product and become pregnant.  For more information on Depakote and pregnancy, visit http://www.depakotebirthinjury.com.
•   Women who use valproate sodium or Depakote and are not planning to get pregnant should use effective birth control.
•   Pregnant women who use valproate or other drugs to treat epilepsy should consider enrolling in the North American Antiepileptic Drug Pregnancy Registry by calling 888-233-2334 or visiting www.aedpregnancyregistry.org.

Depakote has been assigned to pregnancy Class D by the FDA. Class D drugs are associated with positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans.  However there may still be some instances where the benefits of use to the mother outweigh the fetal risk.  

Any person who is currently taking Depakote or who took Depakote during pregnancy and experienced side effects or birth defects and injury in their child is advised to seek consultation. For more information about the serious side effects of Depakote drug use, Dekpakote birth injury information or for Depakote birth defect resources, visit http://www.depakotebirthinjury.com.

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Depakote Birth Injury Resources provides information on Depakote and related products, Depakote side effects, birth defects and birth injuries related to the use of Depakote and other anticonvulsant drugs.