Desyrel Pregnancy Warnings
This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus.
-Some experts recommend: Use with caution; use should be avoided during the first trimester of pregnancy.
US FDA pregnancy category: C
Comment: When this drug is used until delivery, newborns should be monitored for the occurrence of withdrawal symptoms.
Animal studies have revealed evidence of increased fetal resorption and congenital anomalies in adolescents. Other animal models have failed to reveal evidence of adverse effects on embryofetal development, parturition, or postnatal development when given at therapeutic doses. 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.
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Desyrel 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.
-Some experts recommend: Caution is recommended.
Excreted into human milk: Yes
Comments:
-The effects in the nursing infant are unknown.
-The American Academy of Pediatrics considers this agent a drug for which the effect on nursing infants is unknown but may be of concern.
See references