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Ulipristal Pregnancy and Breastfeeding Warnings

Ulipristal is also known as: Logilia, ella

Medically reviewed on May 29, 2018

Ulipristal Pregnancy Warnings

Animal studies have shown embryofetal lethality following repeated administration in the period following implantation in rats, rabbits, and monkeys at subclinical doses. In utero exposure during gestation did not lead to an increase in fetal malformations, skeletal anomalies, or other developmental toxicity in surviving fetuses. Data collected in the US and Europe from 1999 to 2015 have not shown that single-dose emergency postcoital contraceptive use is associated with a pattern of increased risk of adverse outcomes. There are no controlled data in human pregnancy.

A pregnancy registry is suggested for any pregnancy in a woman who has taken this drug for emergency contraception: www.hra-pregnancy-registry.com

AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

Contraindicated

AU TGA pregnancy category: D
US FDA pregnancy category: Not assigned

Risk Summary: Isolated cases of major malformations have been identified; however, the data are not sufficient to determine a risk for birth defects with inadvertent use of during pregnancy.

Comments:
-This drug is contraindicated for use during an existing or suspected pregnancy.
-Following use of this drug as an emergency contraceptive, a reliable barrier method of contraception should be used with subsequent acts of intercourse that occur in that same menstrual cycle.

See references

Ulipristal Breastfeeding Warnings

This drug and its active metabolite are present in breastmilk in small amounts. For women taking a single 30-mg dose, a fully breastfed infant would be expected to receive a weight-adjusted dose of approximately 0.8% of the maternal dose on day 1 and approximately 1% of the maternal dose over the 5-day period. As there is no information on the effects of this drug on the breastfed child or the effects on milk production, it has been suggested that breastfeeding be avoided for 1 week following use and during this time, the mother should express and discard her breast milk in order to stimulate lactation.

Breastfeeding while taking this drug for intermittent treatment of moderate to severe symptoms of uterine fibroids is contraindicated.

Use is not recommended

Excreted into human milk: Yes

Comments:
-When used as a single-dose emergency postcoital contraceptive (30 mg dose), some authorities recommend withholding breastfeeding for 1 week; while others recommend withholding breastfeeding for 24 hours.
-Breastfeeding is contraindicated when this drug is being used to treat symptoms of uterine fibroids in adult women of reproductive age.

See references

References for pregnancy information

  1. "Product Information. ella (ulipristal)." Afaxys Inc., Charleston, SC.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. Cerner Multum, Inc. "Australian Product Information." O 0

References for breastfeeding information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  2. "Product Information. ella (ulipristal)." Afaxys Inc., Charleston, SC.
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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