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Eflornithine topical Pregnancy and Breastfeeding Warnings

Brand names: Florexa, Vaniqa

Eflornithine topical Pregnancy Warnings

Use is not recommended.

AU TGA pregnancy category: B3
US FDA pregnancy category: C

Comments: Women who are pregnant or planning to become pregnant should use alternative therapy to manage facial hair.

Animal studies (in which no precautions were taken to prevent ingestion of drug from application sites) have revealed evidence of fetal adverse effects at doses that also produced maternal toxicity, including reduced number of live fetuses, decreased fetal weights, delayed ossification and development of the viscera. When the study was repeated under conditions that avoided ingestion from application sites, no maternal, fetal, or teratogenic effects were observed at higher doses. There are no controlled data in human pregnancy.

AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.

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.

See references

Eflornithine topical Breastfeeding Warnings

Caution is recommended; according to some experts, use is not recommended.

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

Comments: This drug is poorly absorbed following topical application so it is unlikely to reach the bloodstream of the infant or cause adverse effects in breastfed infants.

See references

See also

References for pregnancy information

  1. (2001) "Product Information. Vaniqa (eflornithine topical)." Bristol-Myers Squibb
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics."
  3. Cerner Multum, Inc. "Australian Product Information."

References for breastfeeding information

  1. (2001) "Product Information. Vaniqa (eflornithine topical)." Bristol-Myers Squibb
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics."
  3. Cerner Multum, Inc. "Australian Product Information."
  4. United States National Library of Medicine (2013) Toxnet. Toxicology Data Network. http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT

Further information

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

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