Pregnancy of Malerone in details
Malerone has been tested by subcutaneous injection and implantation in mice and rats. The implant induced cervical-uterine tumors in mice, which metastasized in some cases. Malerone is also known to increase the number of tumors and decrease the degree of differentiation of chemically induced carcinomas of the liver in rats. There are no adequate data for the use of this drug in pregnant women. 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 X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits.
Use is contraindicated. AU TGA pregnancy category: D US FDA pregnancy category: X Comments: -Treatment with this drug should be discontinued immediately if pregnancy occurs and the potential hazard to the fetus should be evaluated. -There is a potential for transfer of Malerone from men treated with this drug to women who are or may become pregnant. -Treatment with androgens can lead to fertility disorders by repressing sperm-formation (or causing oligospermia) in male patients, and to infrequent or repressed menstrual cycle in female patients. -Exposure of a fetus to androgens may result in varying degrees of virilization.
Use is contraindicated. Excreted into human milk: Yes Excreted into animal milk: Data not available Comments: -The effects in the nursing infant are unknown. -Exposure of a nursing infant to androgens may result in varying degrees of virilization.
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Information checked by Dr. Sachin Kumar, MD Pharmacology