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Darifenacin Pregnancy and Breastfeeding Warnings

Darifenacin is also known as: Enablex

Darifenacin Pregnancy Warnings

This drug was not teratogenic in animal studies at plasma exposures of free drug up to 59 times the maximum recommended human dose (MRHD); no effect at all was observed at 2.8 times the MRHD. There are no controlled data in human pregnancy. It is not known whether this drug can cause fetal harm or adversely affect reproductive capacity in humans.

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.

This drug should be used during pregnancy only if the benefit outweighs the risk.

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

See references

Darifenacin Breastfeeding Warnings

Benefit should outweigh risk.

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

Comments:
-The effects in the nursing infant are unknown.

See references

References for pregnancy information

  1. "Product Information. Darifenacin ER (darifenacin)." Cipla USA Inc., Miami, FL.
  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. "UK Summary of Product Characteristics." O 0
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. "Product Information. Darifenacin ER (darifenacin)." Cipla USA Inc., Miami, FL.

Further information

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

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