Bontril Pregnancy Warnings
Not recommended
US FDA pregnancy category: Not assigned (extended-release)
US FDA pregnancy category: C (immediate-release)
Risk Summary: Weight loss during pregnancy offers no potential benefit and may result in fetal harm.
Comments: A minimum weight gain during pregnancy, and no weight loss, is currently recommended for all pregnant women, including those who are already overweight or obese.
Animal reproduction studies have not been conducted with this drug. During pregnancy, obligatory weight gain occurs in maternal tissues and therefore weight loss is not recommended. There are no controlled data in human pregnancy.
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.
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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Bontril Breastfeeding Warnings
A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.
Excreted into human milk: Unknown
Excreted into animal milk: Data not available
Comments: This drug has pharmacological activity similar to the amphetamines; amphetamines are present in human milk.
See references
