Ulipristal Pregnancy and Breastfeeding Warnings

Ulipristal is also known as: ella

Ulipristal Pregnancy Warnings

Animal studies have failed to reveal evidence of teratogenicity; however, the drug has an embryolethality effect in animals. There are no controlled data in human pregnancy. US 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.

Use is contraindicated. US FDA pregnancy category: X Comments: After drug treatment, use of a reliable non-hormonal barrier method of contraception is recommended until the next menstrual period starts.

Ulipristal Breastfeeding Warnings

Ella(R) and ellaOne(R): During the week after drug treatment, breastfeeding is not recommended and patients are advised to express and discard breast milk in order to stimulate lactation.

SEVERITY: MAJOR LEVEL 1: Ella(R) and ellaOne(R): Use is not recommended. Esmya(R): Use is contraindicated. Excreted into human milk: Yes Comments: The effects in the nursing infant are unknown.

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