Depakote is an anti-seizure medication that is taken in oral form. This medication, as the generic divalproex, was first approved in 1978 for the treatment of epilepsy and other seizure disorders. Depakote (divalproex) is also used to treat bipolar disorder. You may have also heard this drug called valproic acid because this is the active ingredient in divalproex.
These medications by whichever name you choose are classified as Category D drugs regarding birth defects. What this means is that the FDA places the drug in a category of high risk for causing potentially life-threatening birth defects. This is such a severe classification that these medications should never be given to pregnant women without extreme consideration for the likely effects on the fetus.
Besides birth defects here are the known side effects of Depakote:
• Anorexia – loss of appetite
• Polyphagia or hyperphagia – increased appetite
• Weight gain
• Loss of balance
• Dizziness
• Impaired coordination
• Dream abnormalities
• Vomiting
• Fever
• Darkened urine
As serious as these side effects sound they can get worse. There is a classification of side effects from the FDA called “Black Box” side effects. These are potentially serious side effects.
Depakote was assigned a Black Box warning in 2006. Side effects include:
• Hepatoxicity – damage to the liver from some chemical
• Teratogenicity – capability of causing birth defects
• Pancreatitis – inflammation of the pancreas (a serious illness)
Risks to unborn babies are extremely dangerous. Those could include:
• Cleft palate
• Hypoplastic right heart
• Undescended testes
• Malformation of the hands
• Dysplastic ribs
• Hypospadia
• Spina bifida
• Fetal death
These “black box” side effects can be anywhere from surgical intervention to serious lifetime consequences to death.
The same year that Depakote received the Black Box warning, it was also the second most prescribed epilepsy medication. Valproate is now the word wide leader in anti-epileptic meds.
So what’s the real risk to the fetus you might wonder?
The New England Journal of Medicine published evidence to support a fourfold increased risk of birth defects when mothers took anti-seizure medications. Those risks include risk rates as follows:
• Almost 13 times the risk for Spina Bifada
• 7 times the risk of cranio-synostosis
• 5 times the risk of cleft palate
• 2.5 times the risk of atrial septal defect
• 2 times the risk of poly-dactyl
There’s no doubt if you took Depakote, a generic, or valproate during pregnancy and you have a child born with birth defects, you need to talk to a Depakote attorney. Your situation and your child should be fully evaluated to see the full diagnosis, prognosis, and all costs that have been and will be associated with caring for your child.
In 2012, due to investigation outcomes and a plea of guilty, Abbot Laboratories agreed on a $1.5 billion settlement due to marketing Depakote for uses other than those approved by the FDA.
Mark Kaire has been practicing law in Miami for nearly 30 years. He is dedicated to helping the injured people of Miami receive compensation. Mr. Kaire has been blogging on Miami’s legal issues for many years.