Studies and legislation in Italy, France, and the United Kingdom have reinforced the dangers of epilepsy drug valproate – a drug already listed as dangerous here in the United States. Here is what women around the world need to know about valproate and birth injuries. If you have questions about any medication you are taking and are planning to become pregnant, or are currently pregnant, contact your doctor before making any changes.
What is Valproate?
There are several drugs listed as valproate products, including Depacon (valproate sodium), Depakote (divalproex sodium), and Depakene (valproic acid). These drugs are approved by the U.S. Food and Drug Administration (FDA) to treat seizures, migraine headaches, and mixed or manic episodes caused by bipolar of manic-depressive disorder. There are also a handful of off-label (unapproved) uses recognized by the FDA.
FDA Warnings about Valproate and Birth Injuries
For many years, the FDA has urged women who are pregnant, or planning to become pregnant, to talk to their doctor before taking valproate-related products. Women already prescribed the medication should not stop taking it, but should contact their doctor as soon as they suspect that they are pregnant.
In 2011, the FDA released a consumer alert based on research that showed children who were born to mothers taking valproate during pregnancy had reduced cognitive scores at the age of three. Following the FDA alert, research publised in Lancet Neurology suggested that exposure to valproate products while in utero resulted in a decreased IQ compared to children exposed to other antiepileptic medications.
Worldwide Attention to Valproate Dangers
As far back as the 1980’s, Italy and France had released warnings about potential risks associated with taking valproate during pregnancy. One study found a significant correlation between exposure to valproate and the occurrence of spina bifida. It was this and other related research that first led the Centers for Disease Control and Prevention, as well as other organizations, to take a critical look at valproate and the risk of birth injuries.
More recently, the UK has taken drastic measures to prevent women and children from being harmed by valproate drugs. In April 2018, the UK’s drug regulator, Medicines and Healthcare products Regulatory Agency (MHRA), license changes for valproate, meaning that there are new regulations for doctors prescribing related medications. The new Pregnancy Prevention Programme requires that:
- Women prescribed valproate products must meet with her doctor every year to discuss the risks to unborn children.
- Women must sign an acknowledgement form at least every year, stating that she recognizes the risks of taking the medication.
- Women must be advised of the importance of contraception while being treated for seizures or other disorders requiring a valproate prescription.
Since the 1970’s, it is estimated that around 20,000 children in the UK have suffered disabilities due to valproate exposure. That accounts for a risk factor of up to four out of every 10 babies being at risk for developing developmental disorders. It also accounts for around one out of 10 babies being at risk for suffering birth defects.
Valproate Information for Women
Valproate is FDA approved, which means that it is safe and effective for certain patients and conditions. However, the FDA and other organizations have clearly identified potential risks of taking valproate-related medications during pregnancy. So, what should women do about the risks of valproate and birth injuries?
- Before taking valproate products, talk to your doctor about your health and any plans you have to become pregnant in the future.
- If you are planning to become pregnant or have recently found out you are pregnant, talk to your doctor about other treatment options. In such situations, the FDA recommends only using valproate if other treatments have not properly controlled the condition.
- For treatment of migraine headaches, the FDA has listed valproate products as a Category X, meaning that the risks clearly outweigh the benefits and the drug should not be used during pregnancy.
- Never stop taking valproate products suddenly. Doing so can cause medical problems that are serious or potentially life-threatening.
- Women of childbearing age who are taking valproate products should also take effective birth control measures until they can discuss alternative treatment options for a healthy pregnancy.
- If you become pregnant while taking valproate products, talk to your doctor about enrolling in the North American Antiepileptic Drug Pregnancy Registry. This registry collects information about drugs used during pregnancy and any potential side effects.
- If you have been taking valproate throughout a pregnancy, talk to your child’s pediatrician about your medications. Valproate is known to pass through breast milk, but the effects are unknown.
- Any side effects you experience while taking valproate should be reported to the FDA MedWatch
It is not currently known whether the risks associated with taking valproate during pregnancy are higher during a specific period of the pregnancy. It is also unknown whether exposure during a certain period of pregnancy has an impact on the severity of the potential health concerns. Research and review of valproate and birth injuries caused by the drug are ongoing.
Get Help with Medication Related Birth Injuries
While the FDA releases consumer alerts, it is up to healthcare providers to ensure that women are informed, are prescribed the appropriate medication and are monitored closely during pregnancy. If you or your child have suffered adverse side effects, birth injuries or birth defects caused by medications taken during pregnancy, contact Birth Injury Guide to discuss your legal rights. Call us at 1-877-415-6603 or fill out our online form for a free case review.