For years there has been controversy over Depakote because of its potentially serious side effects.
Depakote (divalproex sodium) is a drug manufactured by Abbott Laboratories that was designed for treatment of epileptics and individuals with bipolar disorder. Specifically, it is an anti-seizure drug for epileptics, and medicine used to treat the manic behavior associated with bipolar disorder. In more recent years Depakote has been applied for the purposes of treating both the manic and depressive components of bipolar disorder, as well as for migraine headaches.
Divalproex sodium has been on the market since 1983 as Depakote; there are several generic forms of it manufactured by (among others) Mylan, Dr. Reddy’s Laboratories, Lupin Pharmaceuticals, Sandoz, Sun Pharmaceutical Industries and Teva Pharmaceuticals USA.
Depakote and Birth Defects
For years there has been controversy over Depakote because of its potentially serious side effects. It is known to contribute to liver damage in certain patients with liver problems or in children being treated for seizures. But perhaps the most pervasive, and serious side effect of Depakote is the increased risk for birth defects in children born to women who use the medication during pregnancy.
The FDA has insisted on a boxed warning for Depakote packaging that suggests women who are pregnant or thinking of having a child to find an alternative treatment to Depakote. Data suggest an increased incidence of congenital malformations among the offspring of women with epilepsy receiving valproate during pregnancy compared with those who do not receive antiepileptic drugs (AEDs) and those who receive other AEDs.
According to data reported by the North American Antiepileptic Drug Pregnancy Registry, use of about 1 g/day of divalproex sodium during the first trimester of pregnancy is linked to a 4-fold increased risk for congenital malformations compared with other anti-epileptic drugs.
Depakote and Spina Bifida
Perhaps the most serious congenital side effect associated with Depakote is spina bifida, a malformation or incomplete formation of the embryonic neural tube. The result is an infant born with incomplete spinal formation, allowing exposure of the spinal chord. According to the Centers for Disease Control and Prevention (CDC), the estimated risk for spina bifida among infants born to mothers receiving valproate (a form of divalproex sodium) during the first trimester of pregnancy is 1% to 2% compared with 0.14% to 0.2% in the general population. While the percentages are all low, the increased risk caused by Depakote is a significant order of magnitude.
Depakote Side Effects
The most dangerous Depakote side effects involve damage to the unborn fetus. Consequently, women who are pregnant, likely to become pregnant, or are nursing should not take Depakote because it can cause the following conditions:
- Spina Bifida (a condition that results in the spinal column failing to completely enclose the spinal cord.
- Cleft palate
- Undescended testes
- Hand malformations
- Dysplastic (abnormally developed) ribs
- Hypospadia (a condition in male babies that causes the opening of the urethra to occur in the wrong place)
- Fetal death
If you or a loved one experienced any side effects from use of Depakote, contact the Steinberg Law Firm P.C. at 888-529-4688 or email firstname.lastname@example.org.
Consult A Lawyer on Legal Issues
We encourage you to contact us at 888-529-4688 to discuss your Depakote case with an experienced personal injury and wrongful death attorney.
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Consult A Doctor On Medical Issue
The Steinberg law firm does not intend, by this web site or otherwise, to dissuade anyone from taking medication without their doctors' approval. Please consult your doctor, not your lawyer, on matters relating to your health. It could be dangerous to stop taking medicines, especially abruptly. Patients should talk to their physicians to decide whether the benefits and risks of taking Depakote make it the right choice for them.