R. W. Johnson Pharmaceutical Research Institute
Overall Score for Class Alerts: -1
Positive Signal: Dysmorphogenesis
Although some antiepileptic drugs (AED’s) are teratogenic in animals and humans, not all drugs in this class are teratogenic and no class label exists.
The malformations seen in animal studies with this drug are very characteristic of those seen with carbonic anhydrase inhibitors (CAI’s). Therefore, the mechanism of action of the dysmorphogenesis appears to be related to the carbonic anhydrase inhibitory action of the drug.
While CAI’s have been shown to be teratogenic in animal studies, they have not been associated with malformations in humans.