Zavesca Pregnancy Warnings
Animal studies have revealed evidence of fetal harm. This drug is expected to cross the placenta and has been shown to be embryotoxic in rats and rabbits. Women with type 1 Gaucher disease are at an increased risk of spontaneous abortion especially if disease symptoms are not treated and controlled before conception; disease symptoms may worsen or new symptoms may develop during pregnancy and such symptoms may lead to adverse pregnancy outcomes. There are no controlled data in human pregnancy.
Studies in rats have shown this drug adversely affects sperm parameters, specifically motility and morphology. No effect on sperm concentration, motility, or morphology was observed in 7 healthy men taking 100 mg twice a day for 6 weeks. Until further data is available, male patients should consider stopping this drug before seeking to conceive and using effective contraceptive methods while taking this drug and for 3 months thereafter.
AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details.
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.
Use is not recommended unless the benefit outweighs risk to the fetus
AU TGA pregnancy category: D
US FDA pregnancy category: C
Comment: Effective contraceptive measures should be encouraged for both males and women of childbearing potential.
See references
Zavesca Breastfeeding Warnings
Use is not recommended and a decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.
Excreted into human milk: Unknown
Excreted into animal milk: Data not available
Comments: The effects in the nursing infant are unknown.
See references
