Antiepileptic drug pregnancy registries: do the latest findings concur?
نویسندگان
چکیده
Registry versus clinical trial The main goal of pregnancy registries includes the rapid identification of signals of increased teratogenic risk as quickly as possible, which is especially important for newly available anti epileptic drugs (AEDs) [1–3]. When the association between an increased risk and an AED is found in a registry, the cause can be further explored in a case–control study or aspects of the risk can be studied in a clinical trial. In general, registry data are considered to be less accurate than data from clinical trials because the enrollment criteria in a registry study may be more subject to bias and variability, whereas the enrollment criteria can be refined and strictly controlled for case–control studies or clinical trials. On the other hand, risks discovered in a clinical trial can be evaluated for their importance in a larger population by surveying for them in a registry.
منابع مشابه
Pregnancy, epilepsy, and women's issues.
PURPOSE OF REVIEW Optimal treatment of women with epilepsy includes consideration of the complex interactions of sex steroid hormones with epilepsy and antiepileptic drugs, and of the potential risks of any antiepileptic drug prescribed during a pregnancy. RECENT FINDINGS Clinical studies in women with epilepsy have provided a better foundation of knowledge about the complex relationships bet...
متن کاملSafety of the newer antiepileptic drug oxcarbazepine during pregnancy.
OBJECTIVE Seizure control in pregnant women with epilepsy is vital, as maternal seizures may have deleterious consequences. The treatment of pregnant women with epilepsy is, however, complicated by the teratogenicity of older antiepileptic drugs (AEDs). In this review, the safety of the newer AED oxcarbazepine during pregnancy is assessed based on published pregnancy outcome data. Other relevan...
متن کاملLamotrigine in pregnancy: safety profile and the risk of malformations.
The use of antiepileptic drugs in pregnancy always presents challenges to doctors and their patients as it may have deleterious effects on the developing embryo. Lamotrigine is most commonly-prescribed drug among the newer antiepileptic drugs; hence, it has been selected for the present review. A number of studies pertaining to the safety of lamotrigine use during pregnancy have been reported, ...
متن کاملTeratogenic effects of antiepileptic drugs
The use of older generation antiepileptic drugs (AEDs) during pregnancy is known to be associated with a two- to threefold increased risk of birth defects in the offspring and possible also other adverse outcomes in the exposed infant. Much less has been known about newer generation AEDs in this respect. Recent studies based on national registries as well as specific epilepsy and pregnancy regi...
متن کاملEURAP: an international registry of antiepileptic drugs and pregnancy.
Editor’s note—Several pregnancy registries presently are collecting data on pregnancy outcomes in women with epilepsy. Such registries have inherent limitations of selection bias and incomplete information. Data from the registries cannot easily be combined to achieve greater statistical power, since each registry differs from the other in methodology. Nevertheless, in the likely continued abse...
متن کامل