Depakote (divalproex sodium)
The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Depakote tablets have been approved for the prevention of
The results of two double-blind, placebo-controlled, multicenter
trials established the efficacy of Depakote in reducing the
incidence of migraine headaches. Both studies consisted of a
four-week initial phase, during which subjects were monitored to
determine migraine headache frequency, and a 12-week treatment
phase. Slightly less than half of Depakote-treated subjects showed
reduction in migraine frequency.
Depakote was generally well tolerated in the two clinical
trials. Most frequent adverse events reported by patients receiving
Depakote were nausea, dyspepsia, diarrhea, vomiting, weakness,
fatigue, sleepiness, and dizziness. Events leading to
discontinuation included hair loss, nausea, vomiting, weight gain,
Other safety considerations include hepatic failure, which has
resulted in fatalities in subjects receiving valproic acid and its
derivatives, usually in the first six months of treatment. Valproic
acid can produce teratogenic effects in the offspring of women
receiving the drug during pregnancy. Divalproex sodium is a
derivative of valproic acid. The use of Depakote tablets for
migraine prophylaxis in women of childbearing potential requires
that the benefits of its use be weighed against the risk of injury
to the fetus.
Approximately 23 million Americans suffer from migraine
headaches. Of those, approximately 11 million suffer moderate to
severe migraines that are disabling. Migraine headaches are
characterized by intense, recurrent pain on one or both sides of
the head, and usually are accompanied by one or more concurrent
symptoms, including nausea, vomiting, and an increased sensitivity
to noise and/or bright light.
Treatment for migraine may involve acute therapies, which are
taken by the subject at the onset of a migraine, or preventive
treatments, which may involve daily drug therapy.