Teratogenic studies of tolnaftate, an antifungal agent, in humans have not been published. The population-based data set of the Hungarian Case-Control Surveillance of Congenital Abnormalities, 1980-1996 contained 22,843 fetuses or newborns with congenital abnormalities and 38,151 matched controls without congenital abnormalities. The mothers of 13 cases and 13 controls were treated with tolnaftate spray during pregnancy. Four cases had congenital cardiovascular malformations in the group of cases (OR with 95% CI: 3.1, 1.0-9.7), but these cardiac defects were different. Thus, it is a signal for the potential teratogenic risk of tolnaftate in a case-control study, though the number of cases and controls were limited. Therefore, international collaboration is needed for the final conclusion.
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