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Rotigotine Pregnancy and Breastfeeding Warnings

Rotigotine is also known as: Neupro

Medically reviewed on March 19, 2018.

Rotigotine Pregnancy Warnings

Animal studies have revealed evidence of embryotoxicity or teratogenicity. In mice, rats, and rabbits, an adverse effect on embryo-fetal development at doses similar to or lower than those used clinically was observed. 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.

Use should be avoided.

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

Comments: Use of adequate methods of contraception should be encouraged.

See references

Rotigotine Breastfeeding Warnings

Subcutaneous administration to rats from gestation to weaning was associated with impaired auditory startle reflex during lactation and delays in some developmental indices. In humans, decreased prolactin secretion could potentially inhibit lactation.

Breastfeeding is not recommended during use of this drug.

Excreted into human milk: Unknown
Excreted into animal milk: Yes

Comments: The effects in the nursing infant are unknown; however, since this drug decreases prolactin secretion in humans, inhibition of lactation is expected.

See references

References for pregnancy information

  1. "Product Information. Neupro (rotigotine)." Schwarz Pharma, Mequon, WI.
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

References for breastfeeding information

  1. "Product Information. Neupro (rotigotine)." Schwarz Pharma, Mequon, WI.
  2. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT." ([cited 2013 -]):
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  4. Cerner Multum, Inc. "Australian Product Information." 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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