Depakote is an anti-seizure medication approved for use by the FDA for epilepsy treatment, bipolar disorder, and the prevention of migraine headaches. Depakote is approved for adults and children 10 and older for seizure treatment and for ages 16 and older for migraine prevention. Depakote has been marketed in the US since 1983 by Abbott Laboratories.
Serious and even fatal side effects linked to Depakote use
Side effects of Depakote include serious and possibly fatal liver damage, especially in children younger than two. Symptoms of the liver damage caused by Depakote include nausea or vomiting that does not go away, loss of appetite, pain on the right side of a user’s abdomen, dark urine, swelling of the face, and yellowing of the skin or eyes. Anyone experiencing such symptoms while taking Depakote should contact a healthcare provider immediately. Use of Depakote may also cause inflammation of the pancreas, which may cause death. Symptoms of inflammation of the pancreas include severe stomach pain that may also be felt in the back, as well as nausea or vomiting that does not go away. Suicidal thoughts may also be caused by Depakote, and anyone taking Depakote who experiences suicidal thoughts or new or worse depression, anxiety, irritability or insomnia should contact a health care provider. Persons taking Depakote are advised not to discontinue taking the mediation until speaking with a healthcare provider.
Depakote increases risks of serious birth defects
In addition to the above side effects, the FDA has warned health care professionals and patients in recent years that use of Depakote during pregnancy increases risk of major birth defects, including defects to the brain (which can include significantly reduced IQ), spinal cord defects, craniofacial defects (abnormally formed face and skull enclosing the brain) and cardiovascular malformations (abnormally formed heart or blood vessels). The birth defects occurred in 1-2% of babies born to women who took Depakote while pregnant. The FDA determined that the risks of Depakote by pregnant women clearly outweighed any possible use of Depakote and further recommended that women of childbearing age who are not pregnant avoid using the drug unless it was essential to the maintenance of the woman’s health. The FDA also required that Depakote be relabeled to reflect these significant risks.
Abbott Labs penalized for unlawful marketing of Depakote
Depakote was developed by Abbott Laboratories, and the company has faced numerous criminal and civil penalties for its practices in marketing Depakote over the years. The company previously pled guilty in federal court to misbranding Depakote after a four-year investigation by the Department of Justice into the company’s improper off-label marketing of the drug for treatment of autism and other conditions. As a result, Abbot Laboratories earmarked $1.5 billion in funds for costs related to its liability in that matter. Abbott Laboratories has also faced private litigation related to its wrongdoing in marketing Depakote.
Contact an Attorney if You were Harmed by Depakote Use
Despite the numerous side effects caused by Depakote, Abbott Laboratories continues to market Depakote to treat manic episodes associated with bipolar disorder, seizures, and for the prevention of migraine headaches. If you or someone in your family has taken Depakote and experienced adverse health effects, or if you or someone in your family has experienced birth defects which may have been caused by the use of Depakote, please contact our office for a confidential consultation with a skilled and knowledgeable New York attorney in the field of personal injury and pharmaceutical products liability.