Didrex Pregnancy Warnings
Amphetamines have been shown to be teratogenic and embryotoxic in mammals at high multiples of the human dose. There are no controlled data in human pregnancy.
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.
This drug is contraindicated during pregnancy.
US FDA pregnancy category: X
Comments: This drug may cause fetal harm. The patient should be apprised of the potential hazard to the fetus if this drug is used during pregnancy or if the patient becomes pregnant while taking this drug.
See references
Didrex Breastfeeding Warnings
-Amphetamine was measured in a 12-hour urine collection in a breastfed infant whose mother was taking racemic amphetamine 5 mg four times daily. The infant's urinary excretion of amphetamine ranged from 0.1% to 0.3% of the mother's urinary excretion; this infant showed no signs of abnormal development during the first 2 years of life.
-A study that involved 20 postpartum women revealed evidence that amphetamines may affect serum prolactin levels. A 7.5 mg dose of dextroamphetamine reduced serum prolactin by 25% to 32%, and the 15 mg dose decreased serum prolactin by 30% to 37%. Another study of postpartum women showed a 20 mg dose of dextroamphetamine produced a sustained suppression of serum prolactin by 40%.
-The prolactin level in a mother with established lactation may not affect her ability to breastfeed.
Breastfeeding is not recommended during use of this drug.
Excreted into human milk: Yes
Comments:
-The effect of amphetamine in milk on the neurological development of the breastfed infant has not been well studied.
-Large dosages of amphetamine might interfere with milk production, especially in women whose lactation is not well established.
See references