Depakote Side Effects Attorneys
Personal Injury Lawyers - Representing People Nationwide
Depakote (divalproex sodium or valproate semisodium, consisting of sodium valproate and valproic acid) is used in the United States to treat and/or prevent phases of certain bipolar disorders, as an anticonvulsive in the treatment of epilepsy, to treat migraine headaches, and to treat chronic pain associated with neuropathy.
Although it is thought that Depakote, which is made by Abbott Laboratories, exerts its therapeutic effects on epileptics by increasing their brain concentrations of gamma-aminobutyric acid, the psychodynamic mechanisms by which it does so have not been established. Despite this, in 2000 the Federal Drug and Food Administration FDA approved it for several uses in the United States, including for treating certain cases of epilepsy.
In January 2007, the FDA approved safety label changes warning of an increased risk for congenital malformations in infants exposed to the drug during gestation. And in December 2008, the FDA then warned of an increased risk for suicide by those who take Depakote and other antiepileptic drugs (AEDs).
Even compared with other AEDs, data collected by the North American Antiepileptic Drug Pregnancy Registry suggests that use of one gram per day of valproic acid monotherapy during the first trimester of pregnancy increases the risk for congenital malformations fourfold. The FDA advises that use of valproic acid for women of childbearing potential should only be considered if it is vital for the treatment of their medical condition. The FDA also recommends that all therapeutic risks and benefits be thoroughly discussed with the patient.
The FDA announcement that AEDs must carry warnings about their suicide risks was prompted in large part to the agencys review of 199 clinical trials involving 11 AEDs, which showed nearly double the risk of suicidal thoughts or behavior by patients who used these drugs over those who received placebos. The FDA is also requiring Abbott Laboratories and other makers of AEDs to submit a Risk Evaluation and Mitigation Strategy and a Medication Guide for patients, their families, and their caregivers.
Dyspepsia and/or weight gain is another adverse effect commonly associated with Depakote. Less commonly, Depakote can cause fatigue, peripheral edema, acne, drowsiness, dizziness, hair loss, headaches, nausea, sedation, tremors, hyperammonemia, brain encephalopathy, blood dyscrasia, impaired liver function, thrombocytopenia, jaundice, and prolonged coagulation times.
If you suspect that you or a loved one has been injured as a result of having been prescribed Depakote or other AEDs, you may be entitled to compensation. Contact a qualified pharmaceutical injury attorney for an evaluation of your case.