VALPROATE DRUGS POSE RISKS FOR PREGNANT WOMEN AND WOMEN OF CHILDBEARING AGE

May 16, 2013

On May 6, 2013, the Food and Drug Administration (FDA) released an important safety communication warning pregnant women and women of childbearing age not to use valproate drugs (valproate [Depacon], divalproex [Depakote, Depakote CP, and Depakote ER], valproic acid [Depakene and Stavzor], and their generic counterparts). Pregnant women and those of childbearing age should not use the drugs for the treatment of migraines under any circumstances and should resort to using the drugs for bipolar disorder and epilepsy only if there are no other acceptable treatment options available to them.

Exposure to valproate drugs during pregnancy has long been known to cause serious birth defects, particularly neural tube defects, such as spina bifida.  A recent study, called the Neurodevelopmental Effects of Antiepileptic Drugs (NEAD), has now found that children of mothers exposed to the drugs during pregnancy had IQ scores by age six that were 8 to 11 points lower than children exposed to other anti-epileptic drugs.

The NEAD study results have prompted the FDA to change valproate drugs from pregnancy Category D (drugs in which the possible benefits might outweigh the potential risks) to pregnancy Category X (drugs whose risks clearly outweigh any potential benefits) for the treatment of migraines. Although valproate drugs will remain in Category D for the treatment of bipolar disorder and epilepsy, the FDA’s communication specifies that they should only be used for these conditions if there is no other acceptable treatment option available.

Public Citizen alerted WorstPills.org subscribers to these concerns in June 2011, after the FDA issued a similar warning of adverse cognitive effects in response to preliminary NEAD study results.

If you are pregnant or a woman of childbearing age, do not under any circumstances use valproate drugs for the treatment of migraines. Several other available treatments are safer. See the treatment recommendations for migraine headaches listed on WorstPills.org.

If you have bipolar disorder or epilepsy, do not use valproate drugs unless you have tried and failed all other treatments first, or unless you cannot tolerate any other treatment for other reasons (see the treatment recommendations on bipolar disorder and epilepsy at WorstPills.org). If you are not pregnant but are of childbearing age and must take the drugs for either of these two conditions, you should use two forms of birth control at all times (e.g., a maintenance therapy, such as a birth control pill, in addition to using a condom during sexual intercourse). See our treatment recommendations on contraceptive treatments.

Never stop any medication without first consulting your doctor, but speak with your doctor immediately if you are currently pregnant or of childbearing age and taking these drugs.

To read the FDA’s drug-safety communication, visit http://www.fda.gov/Drugs/DrugSafety/ucm350684.htm.