Pharmacology and toxicology
Hoyme (1998) reported on a growth-retarded girl with hirsutism and dysmorphic features of the nose and distal phalanges, whose mother took 700 mg topiramate twice daily throughout the whole pregnancy. In the post-marketing surveillance system of the company, 38 exposed pregnancies (17 of them monotherapy) were registered; 3 of the polytherapy-exposed infants had congenital anomalies. Yerby (2003) mentioned 5 cases of hypospadias among 110 pregnancies reported to the drug company without details. Additional case reports with normal outcomes were reported by Ohman (2002), and Vajda (2003). The UK registry data (Morrow 2006) include 28 pregnancy outcomes with exposure to topiramate monotherapy, and 2 major congenital malformations (cleft lip and palate, hypospadias) were observed.
In summary, about 150 exposed pregnancies so far have a documented outcome, but this experience is insufficient to rule out a moderate risk, given the fact that topiramate is teratogenic in animal experiments, sometimes with an equivalence of only 20% of the human dosage (per surface area).
Recommendation. A risk assessment is not possible due to a lack of experience. There is no reason today to terminate a pregnancy which has occurred during treatment. As is the case with other anticonvulsants, especially with combination therapies, an increased rate of birth defects is to be expected. An expanded prenatal diagnosis with a detailed fetal ultrasound during the second trimester should be performed to rule out major disturbances of structural development.
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