On May 6, 2013, the U.S. Food & Drug Administration, (“FDA”), issued an “FDA DRUG SAFETY COMMUNICATION: VALPROATE ANTI-SEIZURE PRODUCTS CONTRAINDICTED FOR MIGRAINE PREVENTION IN PREGNANT WOMEN DUE TO DECREASED IQ SCORES IN EXPOSED CHILDREN“, and is advising medical providers and health care professionals that certain anti-seizure medications are contraindicated and should not be taken by pregnant women for the prevention of migraine headaches. Specifically, the anti-seizure medication valproate sodium, and related products, valproic acid and divalproex sodium are contraindicated in pregnant women. A recently released study prompted this FDA SAFETY COMMUNICATION and is noted as finding some association between the use of these anti-seizure medications and decreased IQ scores in children whose mothers took them while pregnant.
As a result of this FDA SAFETY COMMUNICATION stronger warnings about the use, during pregnancy, will be added to the labels and the valproate’s pregnancy category for migraine use will be changed from “D“, which signifies that the “potential benefit of the drug in pregnant women may be acceptable despite its potential risks” to an “X” signifying that the “risk of use in pregnante women clearly outweighs any possible benefit of the drug“.
Well known valproate products include the following brand name or trademarked products:
The FDA is advising health care professionals that valproate use in women with epilepsy or bipolar disorder should only continue if other medications are not effective in treating the condition or are otherwise unacceptable. They will remain category “D” for treating epilepsy or manic episodes associated with bipolar disorder. With regard to women of childbearing age who are not pregnant, the FDA note that valproate should not be taken for any condition unless the drug is essential to the management of the woman’s medical condition. Finally, the FDA’s SAFETY COMMUNICATION also recommends that all non-pregnant women of child bearing age taking valproate products use effective birth control.
Women who are presently pregnant and taking valproate medication should not stop their medication. Rather, they are advised to talk to their health care professionals immediately. FDA warns that stopping valproate treatment suddenly can cause serious and life-threatening medical problems to the mother and her unborn baby.
It is not presently known whether a certain amount of exposure can result in negative cognitive effects. Nor is it known during what time exposure may be considered to have less risk. The study cited by FDA, the NEAD (“Neurodevelopmental Effects of Antiepileptic Drugs“) showed a decrease in IQ at age 6 with a variety of findings in comparison to other anti-epileptic drugs.
This communication is a follow up to a June 2011 FDA DRUG SAFETY COMMUNICATION where lower cognitive test scores at age 3 were noted in children exposed to valporate in comparison to other antiepileptic drugs.
Valproate products have a long standing history of being linked to birth defects, including neural tube defects or spina bifida, which is warned about in the drug labeling.
In 2012, the FDA estimates that 1.5 Million patients received a dispensed prescription for valproic acid and related products. Of that, nearly 22%, or 341,000 patients, were women of reproductive ages between 13 – 45 years old. The FDA also estimates, based upon information provided to office-baed physician survey data that in 2012, 57% of all drug use mentions for valproic acid, or related products, was in women in this reproductive age group, and was associated with diagnosis of epic mood disorder, schizophrenic disorders, migraines or epilepsy. As such, over 1/2 of the mentions in this age group were associated with women of reproductive age with about 9% being associated with migraine treatment and another 9% for epilepsy and recurrent seizures.