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Anticonvulsant drug teratogenicity

Battino et al. (1) report a prospective study of malformations in offspring of 305 epileptic women. The study is quite interesting as it confirms the higher incidence of major malformations in the offspring of epileptic mothers. However, the main message of the study is not substantiated by the results. The authors claim that they discovered a higher incidence of major and minor malformations in the offspring of mothers treated with valproic acid than with other anticonvulsants and perhaps this is related to the higher plasma levels of the drug in the first trimester of pregnancy. If one looks at their data, they have had 22 mothers on valproic acid alone and in five of them major malformations were reported. Two of these five have a hereditary congenital syndrome (Smith-LemliOpitz syndrome) which is probably not related to the anticonvulsant medication. The second point of the serum levels is quite interesting. The authors do not comment on the timing of blood sampling and its relation to the time of the last dose. One is not sure whether this was uniformly applied to all patients. More importantly, polytherapy has been shown to be probably a more important factor in anticonvulsant teratogenicity in general (2-4) and indeed on polytherapy; 8 of 102 births in the reported study showed major malformations: five of the eight were on phenobarbitione, two on valproate, two on carbamazepine, two on phenytoin, two on ethosuximide and one each on primidone, clonazepam and sulthiam. Interestingly, of the three cases with neural tube defects reported (anencephaly, cystic spina bifida and spina bifidahydrocephalus) the first and third were on valproate alone and the second was on c arbamazepine. This study only shows that, in spite of the large numbers of epileptic mothers followed, the results of the malformations are too small to allow any serious conclusions to be drawn. There is no doubt that anticonvulsants in general are teratogenic, but when one is faced with a prospective mother with epilepsy the advice given should surely be based on more solid data from much larger studies than the one reported. References