In rats, an increased incidence of hydroureter and/or hydronephrosis have been observed in offspring at all doses, the lowest dose being similar to the maximum recommended human dose on a mg/m2 basis. Women of childbearing potential should receive counseling on the risk of fetal abnormalities with use of antiepileptic drugs (AEDs) during pregnancy AEDs should generally be continued during pregnancy utilizing monotherapy at the lowest effective dose as this has been shown to minimize risks of fetal abnormalities compared to combination AED therapy.Īnimal studies have revealed evidence of developmental toxicity (increased fetal skeletal and visceral abnormalities, and increased embryofetal mortality) when administered at doses similar to, or lower than expected clinical doses. The risk of having a child with a congenital defect as a result of antiepileptic medication is far outweighed by the dangers to the mother and fetus of uncontrolled epilepsy folic acid supplementation (5 mg) should be started 4 weeks prior to and continued for 12 weeks after conception. Risk Summary: There are no data on the developmental risks associated with use of this drug in pregnant women in animal studies, developmental toxicity was observed at doses estimated to be similar or lower than those used clinically. Pregnancy categories A, B, C, D, and X are being phased out. US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Accompanying texts should be consulted for further details. For additional information: ĪU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. Healthcare providers are encouraged to prospectively register patients. To monitor maternal-fetal outcome of pregnant women exposed to antiepileptic drugs, the North American Antiepileptic Drug (NAAED) Pregnancy Registry has been established. There are no controlled data in human pregnancy.

Several studies have suggested an increased risk of congenital malformations associated with the use of minor tranquilizers (i.e., chlordiazepoxide, diazepam, meprobamate) during the first trimester of pregnancy. A pregnancy exposure registry is available. The patient should be warned of the potential risks to the fetus and instructed to discontinue the drug prior to becoming pregnant. Benzodiazepines may cause fetal harm when administered during pregnancy. The child born to a mother taking benzodiazepines may be at risk for withdrawal symptoms.

There are no adequate studies of this drug in pregnant women to inform a drug-related risk. Risk Summary: Use may be associated with an increased risk of congenital malformations. This drug is only recommended for use during pregnancy when there are no alternatives and the benefit outweighs the risk, especially during the first trimester of pregnancy. The following applies to the ingredients:

Xanax and grapefruit juice