Pregnancy: There are no studies of darifenacin in pregnant women. Animal studies have shown toxicity to parturition, peri and post-natal development (see Pharmacology: Toxicology: Preclinical safety data under Actions). ENABLEX is not recommended during pregnancy.
Lactation: Darifenacin is excreted into the milk of rats. It is not known whether darifenacin is excreted into human milk and therefore caution should be exercised before ENABLEX is administered to a nursing woman.