First trimester exposure to topiramate and the risk of oral clefts in the offspring: A systematic review and meta-analysis

•Topiramate is used at childbearing ages to treat epilepsy and other indications.•There is still a controversy on risks of TPM during the first trimester of pregnancy.•This study quantifies the overall risk of topiramate-induced oral clefts in the offspring. Topiramate (TPM) is an increasingly used...

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Bibliographic Details
Published in:Reproductive toxicology (Elmsford, N.Y.) N.Y.), 2015-06, Vol.53, p.45-50
Main Authors: Alsaad, Abdulaziz M.S., Chaudhry, Shahnaz Akthar, Koren, Gideon
Format: Article
Language:English
Subjects:
Anti-Obesity Agents - adverse effects
Anticonvulsants - adverse effects
Cleft Palate - chemically induced
Epilepsy
Female
Fructose - adverse effects
Fructose - analogs & derivatives
Humans
Infants
Oral cleft
Pregnancy
Pregnancy Trimester, First
Prenatal Exposure Delayed Effects
Risk
Teratogenicity
Topamax
Topiramate
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Summary:•Topiramate is used at childbearing ages to treat epilepsy and other indications.•There is still a controversy on risks of TPM during the first trimester of pregnancy.•This study quantifies the overall risk of topiramate-induced oral clefts in the offspring. Topiramate (TPM) is an increasingly used drug during childbearing ages for treatment of epilepsy, migraine, and appetite suppression as well as for off-label indications such as sleep and psychiatric disorders. Presently, while some reports suggested an increased risk of oral cleft (OC), these reports are balanced by studies that could not confirm such association. We conducted a meta-analysis of all studies reporting on women exposed to TPM during pregnancy. Of the 2327 publications reviewed, 6 articles met the inclusion criteria including 3420 patients and 1,204,981 controls. The odd ratio (OR) of OC after the first trimester exposure to TPM exposure was 6.26 (95% confidence interval: 3.13–12.51; P=0.00001). This study provides strong evidence that TPM is associated with an increased risk of OC in infants exposed to TPM during embryogenesis and should lead to a careful review of TPM use in women of reproductive ages.
ISSN:0890-6238
1873-1708
DOI:10.1016/j.reprotox.2015.03.003