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Solifenacin Pregnancy and Breastfeeding Warnings

Solifenacin is also known as: VESIcare

Solifenacin Pregnancy Warnings

Animal studies have failed to reveal evidence of embryotoxicity or teratogenicity when exposed to 1.2 times the maximum recommended human dose (30 mg/kg/day). Reduced fetal body weight has been observed in mice when exposed to 3.6 times the maximum recommended human dose (100 mg/kg). An increase incidence in cleft palate has been reported in mice exposed to 7.9 the maximum recommended human dose (250 mg/kg). 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 Comment: -This drug has been shown to cross the placenta in pregnant animals.

See references

Solifenacin Breastfeeding Warnings

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother. Excreted into human milk: Unknown Excreted into animal milk: Yes Comment: -The effects in the nursing infant are unknown.

Because there is no published experience with this drug during breastfeeding and it has a long half-life averaging 55 hours, an alternate drug may be preferred, especially while nursing a newborn or preterm infant. Long-term use might reduce milk production or milk letdown; therefore, during long-term use, the infant should be observed for signs of decreased milk production (e.g., insatiety, poor weight gain) and for anticholinergic symptoms (e.g., constipation, urinary retention, UTI, dry mouth).

See references

References for pregnancy information

  1. "Product Information. VESIcare (solifenacin)." GlaxoSmithKline, Research Triangle Park, NC.
  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. VESIcare (solifenacin)." GlaxoSmithKline, Research Triangle Park, NC.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. Cerner Multum, Inc. "Australian Product Information." O 0
  4. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL:" ([cited 2013 -]):

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