Asenapine Pregnancy and Breastfeeding Warnings

Asenapine is also known as: Saphris

Asenapine Pregnancy Warnings

FDA pregnancy category: C Use asenapine only if clearly needed and benefit outweighs potential risk. Adequate methods of contraception should be encouraged.

Animal studies have revealed evidence of increases in postimplantation loss, increases in early pup deaths, decreases in subsequent pup survival, and decreases in weight gain. There are no controlled data in human pregnancy. Neonates exposed to antipsychotic drugs during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery. There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress and feeding disorder in these neonates. These complications have varied in severity; while in some cases symptoms have been self-limited, in other cases neonates have required intensive care unit support and prolonged hospitalization. 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.

Asenapine Breastfeeding Warnings

Use of asenapine is not recommended. Excreted into human milk: Unknown Excreted into animal milk: Yes The effects in the nursing infant are not known.

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