NEW YORK -- July 30, 2008 -- The US Food and Drug Administration (FDA) has approved valproic acid (Stavzor) delayed-release capsules in 125-, 250-, and 500-mg strengths.
"The small size and soft gel capsule formulation of valproate should make this new product easy to swallow, which in my experience is critical to helping valproate patients start, and stay on, their medication," said Miguel Martelli, MD, a psychiatrist in private practice in Saint Marys, Georgia.
Valproate products should not be administered to patients with hepatic disease or significant hepatic dysfunction. In a clinical trial of valproate in elderly patients with dementia, some patients experienced somnolence, sometimes requiring discontinuation.
Cases of life-threatening pancreatitis, some rapidly progressing to death, have been reported in both adults and children receiving valproate. Valproate is contraindicated in patients with known urea cycle disorders. Administration of valproic acid and topiramate has been associated with hyperammonaemia, with and without encephalopathy.
Common adverse events (>5% incidence) associated with valproate in clinical studies were nausea, somnolence, dizziness, vomiting, asthenia, abdominal pain, dyspepsia, rash, diarrhoea, increased appetite, tremour, weight gain, back pain, alopecia, headache, fever, anorexia, constipation, diplopia, amblyopia/blurred vision, ataxia, nystagmus, emotional lability, thinking abnormal, amnesia, flu syndrome, infection, bronchitis, rhinitis, thrombocytopenia, ecchymosis, peripheral oedema, insomnia, nervousness, depression, pharyngitis, dyspnea, and tinnitus.
SOURCE: Noven Therapeutics, LLC
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