Anagrelide Pregnancy Warnings
Use is not recommended.
AU TGA pregnancy category: B3
US FDA pregnancy category: C
Comments:
-If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential harm to the fetus.
-Use of adequate methods of contraception should be encouraged.
A study in female rats revealed that anagrelide hydrochloride at oral doses equivalent to 49 times the recommended maximum human dose or higher disrupted implantation and exerted adverse effect on embryo/fetal survival, produced delay or blockage of parturition, deaths of nondelivering pregnant dams and their fully developed fetuses, and increased mortality in the pups born.
AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.
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.
See references
