Potiga Pregnancy Warnings
-Not recommended during pregnancy and in women of childbearing age not using contraception. (UK)
-This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus. (US)
US FDA pregnancy category: C
Animal studies have revealed evidence of increased pre- and postnatal mortality, developmental toxicity, increased fetal skeletal variations, decreased fetal body weights, and delayed reflex development (e.g., auditory startle response development) in offspring. There was no effect on fertility or general reproductive performance, but the plasma levels achieved in these studies were less than those reached in humans at recommended doses. There are no controlled data in human pregnancy, and the effects on human labor and delivery are unknown.
The risk of congenital malformations, such as cleft lip and neural tube defects, is increased by a factor of 2 to 3 in the offspring of mothers treated with antiepileptic drugs compared with the expected incidence in the general population of approximately 3%. Therapy with multiple antiepileptic drugs is associated with a higher risk of congenital malformations than monotherapy and therefore monotherapy should be used whenever possible.
To monitor the outcomes of pregnant women exposed to this drug, physicians are advised to recommend pregnant patients enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry by calling 1-888-233-2334; enrollment must be done by patients themselves. Information on the registry can be found at www.aedpregnancyregistry.org.
US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
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