Serzone Pregnancy Warnings
Animal studies have shown no malformations; however, increased early pup mortality and decreased pup weights have been reported. There are no adequate and well-controlled studies in pregnant women.
To monitor maternal-fetal outcomes of pregnant women exposed to antidepressant therapy, a National Pregnancy Registry for Antidepressants has been established. Healthcare providers are encouraged to prospectively register patients. For additional information: https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/antidepressants/
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.
This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus.
US FDA pregnancy category: C
Comments:
-A pregnancy exposure registry is available.
-Patients should be advised to notify their healthcare provider if they become pregnant or intend to become pregnant during treatment.
See references
Serzone Breastfeeding Warnings
Caution is recommended.
Excreted into human milk: Unknown
Excreted into animal milk: Data not available
Comments:
-The effects in the nursing infant are unknown.
-The American Academy of Pediatrics classifies other antidepressants as drugs whose effects on the nursing infant are unknown but may be of concern.
-Patients should be advised to notify their healthcare provider if they are breast-feeding.
See references