Lancet neurology
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Most women with active epilepsy need treatment with antiepileptic drugs during pregnancy. Antiepileptic drugs are also frequently used for other indications, such as migraine, pain syndromes, and psychiatric disorders, which are prevalent among women of childbearing age. ⋯ Adverse drug effects on the fetus can present as fetal loss, intrauterine growth retardation, congenital malformations, impaired postnatal development, and behavioural problems. For optimum use of antiepileptic drugs in women of childbearing age and rational management of epilepsy during pregnancy, a thorough understanding of the teratogenic effects of antiepileptic drugs and knowledge of the differences in risks between various treatment options are needed.
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Clinical trials as part of antiepileptic drug development are increasingly expensive and complex, with many pitfalls that can derail even promising drugs and devices. Although a third of patients remain resistant to treatment, the availability of more than 20 approved antiepileptic drugs can reduce the incentive to enrol in trials of unproven agents, for which safety is not assured. ⋯ Furthermore, the availability of so many approved treatments raises questions about the ethics and safety of placebo-controlled trials in patients with epilepsy. Novel trial designs, such as time-to-event adjunctive therapy and historical-control monotherapy, might be more acceptable to patients and their doctors because they restrict exposure to placebo or ineffective treatments.