A European drug regulation agency has recommended restricting the anticonvulsant Depakote, generic valproate, over the risk of birth defects.

On Oct. 10, the Pharmacovigilance and Risk Assessment Committee (PRAC), which is part of the European Medicines Agency, issued a series of new recommendations concerning Depakote and possible birth defects. 

The committee’s recommendation holds that “valproate should not be used to treat epilepsy or bipolar disorder in girls and in women who are pregnant or who can become pregnant unless other treatments are ineffective or not tolerated.”

PRAC’s recommendations went on to say that women of childbearing years should use contraception if they are also taking Depakote to avoid the risk of having a child with birth defects over these concerns. However, the report specifically said that patients should not stop taking Depakote without talking to their physicians.

PRAC’s decision came from a review of available data on the Depakote side effects. Some studies of the drug found that children exposed to Depakote before birth were more likely to develop physical birth defects like cleft palates and neural tube defects like spina bifida.

Studies also found that children exposed to Depakote before birth were more likely to have neurological issues, including ADHD, autistic spectrum disorder, and other neurological/developmental/behavioral issues. PRAC acknowledged that the drug was potentially useful for many patients, but that the risk of birth defects was high, and precautions need to be taken accordingly.

Depakote and other psychiatric drugs have come under scrutiny in recent years over concerns related to birth defects. A variety of different antidepressants, mood stabilizers, and anticonvulsants have been linked to an increased risk of a variety of birth defects, including cleft palates, PPHN, skull malformations, and heart defects.

Birth defect lawsuits have alleged that drug makers were aware, or reasonably should have been aware, of the risk of serious birth defects allegedly linked to these drugs. Lawsuits against drug makers over birth defects have alleged that the earliest animal trials of the drugs have indicated that they can cause a variety of birth defects in mammals.

Additionally, birth defect lawsuits further allege that not only were drug makers aware of these risks, but that they did not do enough to protect the public from these risks. Instead, these birth defect lawsuits allege that drug makers continued to aggressively promote their products, endangering women of childbearing years, as well as their children.

Birth defect lawsuits typically seek to recoup the cost of medical care, occupational therapy, lost income potential, and other costs related to the birth defects in question. Many birth defects can be a lifelong challenge both for the child and their caretakers, and a costly one at that.