Depakote (Divalproex Sodium)
Company: Abbott Laboratories
Approval Status: Approved June 1996
Treatment for: epilepsy
Areas: Neurology
Possible similar drugs: Depakote; Depakote ER
| General Information | Clinical Results | Side Effects | Additional Information |
General Information
Depakote has been approved for the treatment of complex partial seizures (CPS), a common type of epilepsy. This is a new indication for Depakote, which has already been approved for the treatment of migraine headaches. The new indication for treatment of CPS includes using Depakote as a sole agent (monotherapy) or as adjunctive therapy for use with other anti-epilepsy drugs. Both Depakote tablets and sprinkle capsules can be used for treatment.
Clinical Results
Depakote-treated subjects showed significant improvement by reducing seizure frequency. This improvement was established in clinical trials with Depakote as adjunctive or monotherapy conducted with subjects who continued to experience seizures while taking their current epilepsy medication. Seizure frequency was calculated to reflect the median number of seizures during an eight-week measurement period versus an eight-week treatment period with Depakote.
Side Effects
In clinical trials, Depakote was generally well tolerated. Most adverse events were mild to moderate in severity. Common adverse events were nausea, tremor, somnolence, vomiting, asthenia, abdominal pain, and anorexia. Other important safety considerations include the possibility of hepatic failure, which has resulted in fatalities in subjects receiving valproic acid and its derivatives, usually occurring during the first six months of treatment. Valproic acid may produce teratogenic effects in the offspring of women receiving the drug during pregnancy, Thrombocytopenia, an abnormally low number of platelets in the blood, has also been associated with Depakote use. The incidence of thrombocytopenia appears to be dose related.
Additional Information
Approximately 2.5 million people in the United States have some form of epilepsy and an estimated 125,000 new cases are diagnosed each year. Depakote has been marketed in the United States since 1983 as a treatment for simple and complex absence seizures.
The FDA drug information shown here is licensed from Thomson CenterWatch. The information provided here is for general educational purposes only and does not constitute medical or pharmaceutical advice which should be sought from qualified medical and pharmaceutical advisers.
