Gleostine Pregnancy Warnings
Animal studies have revealed evidence of embryotoxicity and teratogenicity at dose levels equivalent to the human dose; and fertility impairment in males at doses somewhat higher than the human dose. This drug should be regarded as a potential mutagen. There are no controlled data in human pregnancy.
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 D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
UK: Use of this drug is contraindicated in pregnant patients.
US: Use should be avoided during pregnancy as this drug can cause fetal harm based on animal studies.
AU: Use should be avoided during pregnancy unless the expected benefit outweighs any potential risk.
AU TGA pregnancy category: D
US FDA pregnancy category: D
Comments:
-Female patients of childbearing potential should be advised to avoid becoming pregnant while taking this drug, and should be apprised of the potential hazard to the fetus if pregnancy occurs during treatment.
-All patients should be advised to use effective contraception during treatment and for 6 months after therapy. (UK)
-Male patients should be informed about the possibility of irreversible infertility caused by this drug; advised not to father children during treatment and for 6 months after treatment cessation; and to seek advice regarding sperm conservation prior to treatment initiation. (UK)
See references
