Pregnant women who take Depakote to treat epilepsy may have an increased risk of giving birth to babies with devastating birth defects like spina bifida, oral clefts and heart malformations.
In recent years, a number of studies have re-examined the potential connection between Depakote and major birth defects in children exposed to the popular anticonvulsant drug during pregnancy. According to research, women who become pregnant while taking Depakote may have a significantly increased risk of giving birth to babies with devastating birth defects, like spina bifida, heart defects, cleft palate, skeletal deformities and developmental delays. If you took Depakote while pregnant, and your child was born with a major congenital malformation, contact a knowledgeable Depakote birth defect lawyer today for legal help. You may have grounds to file a Depakote lawsuit against Abbott Laboratories, in order to seek fair and timely reimbursement for your losses.
Depakote Alternatives for Epilepsy During Pregnancy
The FDA has labeled Depakote a pregnancy Category D medication, which means there is positive human evidence showing that the drug can cause harm to a developing fetus. In light of the potential for the widely-used anticonvulsant drug Depakote to cause severe birth defects in babies when taken during pregnancy, expectant mothers and women of childbearing age who are suffering from epileptic seizures, bipolar disorder or severe migraine headaches are looking for safer ways to treat their conditions.
Women who are currently pregnant or planning to become pregnant and are taking Depakote should consult their doctors immediately to discuss the possible pregnancy risks of the anti-epileptic drug. It is not advisable to stop taking a prescription medication without medical consent, as it may cause more harm to you or your child. Instead, your doctor may be able to help you find a less harmful alternative to treating your health condition. The following are some possible alternatives to Depakote for treating epilepsy during pregnancy:
- Herbal treatments (skullcap, lily of the valley, burning bush)
- Folic acid
- Vitamin D, E and B6
- Self-control (recognizing symptoms of an impending seizure so you can control it)
- Meditation
- Acupuncture
- Chiropractic treatments
FDA, Depakote and Birth Defects
2006 – The FDA adds a black-box warning over the potential risk of birth defects from Depakote, after a study finds that 20% of women who become pregnant while taking Depakote give birth to babies with malformations.
2009 – The FDA issues a warning about the potential for Depakote use in pregnancy to cause neural tube defects, craniofacial malformations and heart birth defects in babies.
2011 – A drug safety communication issued by the FDA warns about the alleged link between Depakote use in pregnancy and decreased cognitive functioning in exposed children, including lower IQ scores.
May 2013 – A drug safety communication issued by the FDA indicates that pregnant women should not take Depakote for the prevention of migraine headaches, due to the risk of decreased IQ scores in children exposed to the drug in utero.
August 2014 – Warnings about the potential risk of autism associated with Depakote use in pregnancy are added to the drug label.
Depakote Birth Defect Studies
April 2001 – The New England Journal of Medicine publishes research indicating that babies exposed to anticonvulsant drugs like Depakote in utero have a higher risk of suffering major malformations, including growth retardation and hypoplasia of the midface and fingers (anticonvulsant embryopathy).
August 2006 – Research published in the journal Neurology shows that approximately 20% of babies born to mothers who took Depakote while pregnant suffered serious malformations, compared to other similar medications, which had rates between one and 10.7%.
August 2006 – The Neurodevelopmental Effects of Antiepileptic Drugs study group suggests that Depakote should be at the bottom of the list, when it comes to prescribing anticonvulsant medications to pregnant women with epilepsy.
July 2009 – Research conducted by Hebrew University’s Hadassah Medical School and the Israeli Ministry of Health, and published in the journal Reproductive Toxicology, links exposure to valproic acid in utero to nearly three times as many major birth defects, like spina bifida.
August 2009 – A study published in the New England Journal of Medicine indicates that children whose mothers took Depakote during pregnancy faced a risk of lower IQ scores.
June 2010 – In a study published in the New England Journal of Medicine, researchers find an increased risk of six different birth defects in babies exposed to Depakote in the first trimester of pregnancy, including a 12-times increased risk of spina bifida.
July 2010 – The UK Epilepsy and Pregnancy Register and the European and International Registry of Antiepileptic Drugs in Pregnancy report that Depakote and other valproate-based anticonvulsant drugs are more than twice as likely to cause major birth defects when used during pregnancy, compared to Tegretol and Lamictal.
January 2013 – The Journal of Neurology, Neurosurgery & Psychiatry publishes a study finding that women who take valproate (Depakote) while pregnant have an increased risk of giving birth to children with neurodevelopment problems and autism.
March 2013 – A study published in the international journal Acta Neurologica Scandinavica finds a link between Depakote use in pregnancy and birth defects like spina bifida, heart malformations, and deformities affecting the great vessels, skull bones, digits and brain.
April 2013 – The Journal of the American Medical Association publishes a study indicating that “Maternal use of valproate during pregnancy was associated with a significantly increased risk of autism in the offspring, even after adjusting for parental psychiatric disease and epilepsy.”
2014 – An ongoing, 10-year study involving 550 pregnant women at 20 medical centers examines whether there are differences in how Depakote and other anticonvulsant drugs affect expectant mothers and their unborn babies.
Why We Think Abbott Laboratories Should Be Held Liable for Depakote Birth Defects
Thanks to recent FDA warnings and studies published in reputable medical journals, we now know that Depakote use in pregnancy can cause severe birth defects in babies. But these warnings came too late for many women who took Depakote during pregnancy to treat epileptic seizures or severe migraine headaches, and subsequently gave birth to babies with devastating malformations. After decades on the market in the United States, it was only recently that consumers and healthcare providers were notified about the alleged birth defect risk from Depakote, especially during the first trimester of pregnancy, when many women don’t yet know they are pregnant. Lawsuits alleging birth defects from Depakote typically involve allegations that Abbott Laboratories:
- Manufactured and sold a defective drug
- Failed to adequately research the potential pregnancy risks of Depakote
- Failed to provide warnings to consumers and doctors about the potential risk of birth defects from Depakote
- Downplayed the possible side effects of Depakote
- Continued to market Depakote as a safe and effective treatment for pregnant women with epilepsy
- Promoted Depakote for off-label uses not approved by the FDA
What should you do? If your child was born with spina bifida, cleft lip or a heart defect, you should contact a lawyer as soon as possible to discuss filing a Depakote birth defect lawsuit.
Birth injuries related to the use of Depakote can lead to long-term pain and suffering for an affected child and his or her family. Complications resulting from a birth defect can lead to extensive and costly medical treatments and the need for ongoing care, and children who suffer from a birth malformation allegedly caused by exposure to Depakote in utero deserve to be reimbursed for damages. Many instances of Depakote birth defects have led to birth injury cases and Depakote class action lawsuits. If you or a loved one has been a victim of a birth defect potentially associated with the use of Depakote during pregnancy, an experienced Depakote attorney can help you pursue the compensation you are entitled to. For an attorney claim review, fill out the Depakote injury contact form so that a knowledgeable Depakote lawyer can review your case.
