Ospemifene Pregnancy and Breastfeeding Warnings

Ospemifene is also known as: Osphena

Ospemifene Pregnancy Warnings

FDA pregnancy category: X Use of ospemifene is contraindicated.

Animal studies found embryofetal lethality, neonatal mortality, and difficult labor at maternally toxic doses. Animals given doses of 0.8% to 4% the human exposure based on surface area mg/m2, had prolonged and difficult gestation, increased post-implantation loss, increased number of offspring deaths, and an increased incidence of postnatal loss. The effect on fertility was not directly evaluated, but female animals experienced decreases in ovarian and uterine weights, decreased corpora lutea number, increased ovarian cysts, uterine atrophy, and disrupted cycles; and atrophy of the prostate and seminal vesicles was observed in male animals. There are no controlled data in human pregnancy. 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.

Ospemifene Breastfeeding Warnings

A nonclinical study detected ospemifene in animal milk at concentrations higher than in maternal plasma.

The manufacturer makes no recommendation regarding use during lactation. Excreted into human milk: Unknown Excreted into animal milk: Yes The effects in the nursing infant are unknown.

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