Topiramate in pregnancy: preliminary experience from the UK Epilepsy and Pregnancy Register.
نویسندگان
چکیده
OBJECTIVES Topiramate (Topamax) is licensed to be used, either in monotherapy or as adjunctive treatment, for generalized tonic clonic seizures or partial seizures with or without secondary generalization and for prevention of migraine. The safety of topiramate in human pregnancy is largely unknown. Here we report on our experience of pregnancies exposed to topiramate. METHODS This study is part of a prospective, observational, registration and follow-up study. Suitable cases are women with epilepsy who become pregnant while taking topiramate either singly or along with other antiepileptic drugs (AEDs), and who are referred before outcome of the pregnancy is known. The main outcome measure is the major congenital malformation (MCM) rate. Secondary outcomes include risk of specific MCM, minor malformation rate, birthweight, and gestational age at delivery. RESULTS Full outcome data are available on 203 pregnancies. Of these, 178 resulted in live birth; 16 had an MCM (9.0%; 95% CI 5.6% to 14.1%). Three MCMs were observed in 70 monotherapy exposures (4.8%; 95% CI 1.7% to 13.3%) and 13 in cases exposed to topiramate as part of a polytherapy regimen (11.2%; 95% CI 6.7% to 18.2%). Four of the MCMs were oral clefts (2.2%; 95% CI 0.9% to 5.6%). Four cases of hypospadias were reported (5.1%; 95% CI 0.2% to 10.1%) among 78 known live male births of which two were classified as major malformations. CONCLUSIONS The number of outcomes of human pregnancies exposed to topiramate is low, but the major congenital malformation rate for topiramate polytherapy raises some concerns. Overall, the rate of oral clefts observed was 11 times the background rate. Although the present data provide new information, they should be interpreted with caution due to the sample size and wide confidence intervals.
منابع مشابه
The outcomes of pregnancy in women with untreated epilepsy
PURPOSE To determine the outcomes in regards to seizure control and foetal malformation in pregnant women with epilepsy not treated with antiepileptic drugs (AEDs). METHOD Analysis of data from the Australian Register of AEDs in Pregnancy on 148 women with epilepsy who were not receiving AEDs before and during at least the first trimester of pregnancy. RESULTS Seizure control was less likel...
متن کاملEpilepsy and Pregnancy Register pregnancy: a prospective study from the UK Malformation risks of antiepileptic drugs in
متن کامل
Malformation risks of antiepileptic drugs in pregnancy: a prospective study from the UK Epilepsy and Pregnancy Register.
OBJECTIVE To assess the relative risk of major congenital malformation (MCM) from in utero exposure to antiepileptic drug (AEDs). METHODS Prospective data collected by the UK Epilepsy and Pregnancy Register were analysed. The presence of MCMs recorded within the first three months of life was the main outcome measure. RESULTS Full outcome data were collected on 3607 cases. The overall MCM r...
متن کاملEctopic pregnancy as contraceptive failure in patient with epilepsy.
Epilepsy is a common neurologic condition which includes many women's health issues. Menstrual disorders, reproductive endocrinological disturbances, ovulatory dysfunction and infertility appear to be relatively frequent in women with epilepsy. Clinical decision making which contraceptive regimen is optimal for an individual woman with epilepsy is one of the most challenging tasks when taking c...
متن کاملThe antiepileptic drugs in pregnancy—a register in the UK to determine the relative safety of each in this situation
Abstracts of papers and posters presented at ‘Epilepsy 1998-The Leading Edge’ annual scientific meeting of the British Branch of the International League against Epilepsy, Oxford, October 1998s of papers and posters presented at ‘Epilepsy 1998-The Leading Edge’ annual scientific meeting of the British Branch of the International League against Epilepsy, Oxford, October 1998 Is folic acid protec...
متن کاملذخیره در منابع من
با ذخیره ی این منبع در منابع من، دسترسی به آن را برای استفاده های بعدی آسان تر کنید
برای دانلود متن کامل این مقاله و بیش از 32 میلیون مقاله دیگر ابتدا ثبت نام کنید
ثبت ناماگر عضو سایت هستید لطفا وارد حساب کاربری خود شوید
ورودعنوان ژورنال:
- Neurology
دوره 71 4 شماره
صفحات -
تاریخ انتشار 2008