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.
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:
A popular anticonvulsant drug used to treat epileptic seizures, migraine headaches and mood disorders that is often prescribed to expectant mothers.
Depakote is an anticonvulsant medication prescribed to patients suffering from symptoms of health conditions such as bipolar disorder, epilepsy, migraine headaches and seizures. Depakote is currently manufactured by Abbott Laboratories and can be found in a variety of forms, including Depakote delayed-release tablets, Depakote extended-release tablets, Depakote sprinkle capsules, Depacon injections and Depakene capsules or syrup. The drug was approved by the U.S. Food and Drug Administration (FDA) in 1983 for epilepsy treatment, in 1995 to treat bipolar disorder, and in 1996 for the prevention of migraine headaches, and has been widely prescribed by physicians in the years since. It was in 2008 that the FDA approved the first generic version of Depakote for sale in the United States.
Depakote is a chemical compound consisting of equal parts sodium valproate and valproic acid, and the prescription medication is believed to work by increasing the amount of gamma-aminobutyric acid (GABA) in the brain, which slows down brain signals, thereby decreasing the frequency of seizure episodes. According to Abbott Laboratories, Depakote can be prescribed to treat migraine headaches in adults, acute manic episodes associated with bipolar disorder, as well as seizure disorders including complex partial seizures or simple and/or complex absence seizures. However, some women who took Depakote while pregnant have given birth to babies with severe birth defects, like spina bifida, oral clefts, heart malformations and facial deformities.
When Depakote was first introduced as a treatment for manic episodes of bipolar disorder, it was thought to be a medical breakthrough for individuals experiencing symptoms of mania, like abnormally elevated mood and energy levels, reckless behavior and decision-making with little regard for safety. However, the FDA and Depakote maker Abbott Laboratories have warned patients about the adverse side effects associated with the anticonvulsant drug, including serious liver problems, pancreatitis and death. Depakote has also been linked to devastating and potentially life-threatening birth defects in children who are exposed to the epilepsy drug during pregnancy, including the following:
There has been an increased awareness of the risks associated with taking anticonvulsant drugs like Depakote since 2006, when the FDA required the drug manufacturer, Abbott Laboratories, to include a “black box” warning on the Depakote label. Since then, more stringent requirements have been applied to the anticonvulsant drug, including the development of a medication guide which must be included with each Depakote prescription. More recently, the FDA released several statements officially warning patients about the increased risk of major birth defects and cognitive delays in children who are exposed to Depakote during pregnancy. The FDA’s notices include the frequency of neural tube birth defects, craniofacial abnormalities and cardiovascular malformations, as well as an increased risk of developmental delays and autism. Individuals who have suffered from a birth defect due to the use of Depakote should seek legal advice immediately, as they may be able to file a Depakote class action lawsuit and receive compensation for their injuries.
May 2012 – Abbott agrees to pay $3 million to the state of Arkansas to settle claims that the drug company marketed Depakote for unapproved uses, including autism and schizophrenia.
May 2012 – Abbott Laboratories is ordered to pay $1.6 billion in fines to resolve charges that the drug maker illegally marketed Depakote for off-label uses, including as a treatment for schizophrenia, anxiety and depression.
July 2012 – Twenty-seven mothers file Depakote lawsuits against Abbott in federal court in Illinois, joining a growing number of women pursuing legal claims over birth defects from Depakote.
January 2013 – A South Carolina man files a product liability lawsuit against Abbott, alleging that his spina bifida malformation was caused by his mother’s use of Depakote during the early stages of pregnancy.
December 2013 – A U.S. Magistrate Judge orders Abbott to produce documents in Depakote lawsuits alleging birth defects from the epilepsy medication.
January 10, 2014 – A Depakote lawsuit filed against Abbott Laboratories in the U.S. District Court for the Southern District of Illinois claims that the drug manufacturer failed to provide adequate warnings about the alleged risk of birth defects from the anticonvulsant drug.
June 3, 2015 – A St. Louis jury awards $38 million in compensatory and punitive damages to the family of a girl born with spina bifida and several other birth defects, after being exposed to Depakote in utero.
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.
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.
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:
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.