The U.S. Food and Drug Administration (FDA) has approved a liquid oral form of the medicine valproic acid. This medicine is used to treat epilepsy, specifically for certain types of seizures called complex partial seizures and absence seizures. It can be used by itself or added to other treatments for patients 10 years of age and older. The approval is for a liquid version of a medicine that has been used for many years. This is important because it gives people who have difficulty swallowing pills or capsules a different option. It allows for more flexible dosing based on a person's weight. This approval makes an existing treatment available in a new form that might be easier for some patients to take. It is crucial to understand that this medicine carries serious risks, which are clearly stated in a highlighted warning on its label. These include the risk of severe liver problems and serious birth defects. Because of these risks, doctors will carefully consider if this medicine is the right choice for each patient, especially for women who could become pregnant. If you or a loved one has epilepsy, this news means there is another formulation of a known medicine available. The most important step is to talk with your doctor. They can explain if this specific liquid form might be suitable for your individual situation and answer any questions you have about its use and risks.
FDA approved Valproic Acid Oral Solution (valproic acid) for Monotherapy and Adjunctive Therapy of Complex Partial and Absence SeizuresFDA approved a liquid form of an existing epilepsy medicine called valproic acid
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The FDA has approved valproic acid oral solution for the treatment of epilepsy. The approval covers its use as monotherapy and adjunctive therapy for complex partial seizures, and as sole and adjunctive therapy for simple and complex absence seizures in patients 10 years and older. This approval provides a liquid oral formulation of a well-established antiepileptic drug, which may offer dosing flexibility for patients who have difficulty swallowing tablets or capsules. The label includes a boxed warning regarding the risk of fatal hepatic dysfunction and major teratogenic effects, emphasizing the need for careful patient selection, particularly for women of childbearing potential. Dosing is weight-based, starting at 10 to 15 mg/kg/day and titrated upward, with optimal response typically achieved below 60 mg/kg/day. The label advises that the safety of doses above 60 mg/kg/day is not established.
＋ Clinical Details (Mechanism · Dosing · Trial Data · Warnings)
Not reported in label.
Valproic acid oral solution is indicated as monotherapy and adjunctive therapy in the treatment of patients with complex partial seizures that occur either in isolation or in association with other types of seizures. It is indicated for use as sole and adjunctive therapy in the treatment of simple and complex absence seizures, and adjunctively in patients with multiple seizure types which include absence seizures. It is indicated for adults and pediatric patients down to the age of 10 years. Because of the risk to the fetus of decreased IQ, neurodevelopmental disorders, neural tube defects, and other major congenital malformations, valproate should not be used to treat women with epilepsy who are pregnant or who plan to become pregnant unless other medications have failed to provide adequate symptom control or are otherwise unacceptable. Valproate should not be administered to a woman of childbearing potential unless other medications have failed to provide adequate symptom control or are otherwise unacceptable.
Valproic acid oral solution is intended for oral administration. For simple and complex absence seizures and complex partial seizures: Start at 10 to 15 mg/kg/day, increasing at 1 week intervals by 5 to 10 mg/kg/week until seizure control or limiting side effects. Ordinarily, optimal clinical response is achieved at daily doses below 60 mg/kg/day. If the total daily dose exceeds 250 mg, it should be given in divided doses. Safety of doses above 60 mg/kg/day is not established. If satisfactory clinical response has not been achieved, plasma levels should be measured to determine whether they are in the usually accepted therapeutic range (50 to 100 mcg/mL). The probability of thrombocytopenia increases significantly at total trough valproate plasma concentrations above 110 mcg/mL in females and 135 mcg/mL in males. For conversion to monotherapy, concomitant antiepilepsy drug (AED) dosage can ordinarily be reduced by approximately 25% every 2 weeks.
Trial data not available in label.
The label contains a warning regarding fatal hepatic dysfunction. Because of the risk to the fetus of decreased IQ, neurodevelopmental disorders, neural tube defects, and other major congenital malformations, which may occur very early in pregnancy, valproate should not be used to treat women with epilepsy who are pregnant or who plan to become pregnant unless other medications have failed to provide adequate symptom control or are otherwise unacceptable. Valproate should not be administered to a woman of childbearing potential unless other medications have failed to provide adequate symptom control or are otherwise unacceptable. For prophylaxis of migraine headaches, valproate is contraindicated in women who are pregnant and in women of childbearing potential who are not using effective contraception.
Valproic acid oral solution is indicated for monotherapy and adjunctive therapy of complex partial seizures and for sole and adjunctive therapy of simple and complex absence seizures. Its use is limited in women of childbearing potential and contraindicated in pregnancy for migraine prophylaxis. It offers an oral solution formulation for patients requiring alternative administration.
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