Rogaine men's extra strength Pregnancy Warnings
Use is not recommended.
AU TGA pregnancy category: C
US FDA pregnancy category: Not assigned
Animal studies did not show teratogenicity, but was fetotoxic (decreased conception rate, fewer live pups) in one model. Two infants exposed to oral minoxidil in utero experienced hypertrichosis (a known adverse effect), with the causal relationship to multiple congenital malformations in one and heart defects in the other infant being unclear. Multiple anomalies of unknown cause were reported in 2 infants after topical minoxidil application and maternal flu-like illness in the first trimester. There are no controlled data in human pregnancy. The background birth defect and miscarriage risk for the indicated population is not known. In the US general population, the estimated major birth defect risk is 2 to 4% and the miscarriage risk is 15 to 20%.
AU 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. These effects may be reversible. Accompanying texts should be consulted for further details.
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. Pregnancy categories A, B, C, D, and X are being phased out.
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Rogaine men's extra strength Breastfeeding Warnings
There is one case report of a patient (2 months post-partum) on oral minoxidil 5 mg twice daily who was given a 7.5 mg dose and one hour after that dose had a peak milk level of drug and conjugate of 45.1 mcg/L, declining to 12.4 mcg/L at 3 hours, 4 mcg/L at 4 hours, 1.9 mcg/L at 9 hours, and 0.8 mcg/L at 12 hours after the dose. No hypertrichosis or other abnormalities were seen in one infant breastfed during 2 months of maternal drug therapy.
Use is not recommended.
Excreted into human milk: Yes
Comments:
-This drug is secreted in human milk when systemically absorbed.
-There is no information regarding this drug on the effects on a breastfed infant.
-Risk is anticipated to be low with topical use of this drug.
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