Previous Next. View Larger Image. The EMA made the following specific recommendations regarding the use of valproic acid in this population: If possible, an alternative to valproic acid should be used in women of reproductive age If valproic acid is the only option, women should use effective contraception and should be closely supervised.
Doctors who prescribe valproic acid to women of reproductive age must review the reproductive risks associated with this drug and must clearly explain the reason for choosing valproic acid over other options. Women taking valproic acid should also take 4mg of folic acid daily to reduce the risk of birth defects in the setting of unplanned pregnancy.
It is also not known whether these effects occur when fetal exposure is limited to less than the full duration of pregnancy, such as the first trimester. FDA has evaluated all available evidence to date, and will be adding information about the risk of lower cognitive test scores to the valproate product labels in the Warnings and Precautions section, the Use in Specific Populations: Pregnancy section, and to the Medication Guides that are being developed for the valproate drug products.
FDA previously warned pregnant women and women of childbearing age about valproate use during pregnancy due to the known risk of birth defects teratogenic effects of these products. A teratogen is anything known to cause birth defects during development of an embryo or fetus. Valproate products are assigned to Pregnancy Category D. FDA released an Information for Healthcare Professionals communication in December on the risk of neural tube birth defects following exposure to valproate products during pregnancy.
The benefits and the risks of valproate sodium and related products should be carefully weighed when prescribing these drugs to women of childbearing age, particularly for conditions not usually associated with permanent injury or death.
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Lancet Neurol. Malformation risks of antiepileptic drug monotherapies in pregnancy: updated results from the UK and Ireland epilepsy and pregnancy registers. Support Center Support Center. External link. Please review our privacy policy. Enhances serotonergic neuron activity, inhibits pAp-phosphatase enzyme, interacts with nitric oxide signalling activity. Common: GI upset, fine tremor, polyuria, polydipsia, metallic taste in mouth, ankle oedema, weight gain.
GABA potentiation, blocks voltage gated sodium channels, epigenetically inhibits histone deacetylase. Common: GI upset, hyperammonaemia causing nausea , weight gain, tremor, hair loss with curly regrowth. GABA potentiation, suppresses glutamate release, inhibits serotonin reuptake. Common: tremors, dizziness, tiredness, loss of co-ordination, menstrual disturbance, dry mouth, sleep problems.
Common: dizziness, diplopia, drowsiness, ataxia, nausea, headaches, dry mouth, oedema, hyponatraemia, erythematous rash, sexual dysfunction. Common: sexual dysfunction hyperprolactinaemia. Rare: neuroleptic malignant syndrome.
Dopaminergic D 2 and serotonergic 5-HT 1A receptor partial agonist. Common: weight gain, headache, agitation, insomnia, gastrointestinal effects, disinhibition. Severe toxicity in newborn. Significantly elevates the risk of major defects 7 times higher.
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