Fesoterodine

The Basics

What is Fesoterodine?

Used to treat overactive bladder.

Brand names for Fesoterodine

Toviaz

How Fesoterodine is classified

Muscarinic Antagonists, Parasympatholytics

Fesoterodine During Pregnancy

Fesoterodine pregnancy category

Category Not AssignedNote that the FDA has deprecated the use of pregnancy categories, so for some medications, this information isn’t available. We still think it’s useful to list historical info, however, given what a common proxy this has been in the past.

What we know about taking Fesoterodine while pregnant

There are no data with the use of Toviaz in pregnant women to inform a drug associated risk for birth defects or miscarriage. In animal reproduction studies, oral administration of fesoterodine to pregnant mice and rabbits during organogenesis resulted in fetotoxicity at maternal exposures that were 6 and 3 times, respectively, the maximum recommended human dose (MRHD) of 8 mg/day based on AUC (see Data). The background risk of major birth defects and miscarriage for the indicated population are unknown. However, in the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Data Animal Data No dose-related teratogenicity was observed in reproduction studies performed in mice and rabbits. In mice at 6 to 27 times the expected exposure at the maximum recommended human dose (MRHD) of 8 mg based on AUC (75 mg/kg/day, oral), increased resorptions and decreased live fetuses were observed. One fetus with cleft palate was observed at each dose (15, 45, and 75 mg/kg/day), at an incidence within the background historical range. In rabbits treated at 3 to 11 times the MRHD (27 mg/kg/day, oral), incompletely ossified sternebrae (retardation of bone development) and reduced survival were observed in fetuses. In rabbits at 9 to 11 times the MRHD (4.5 mg/kg/day, subcutaneous), maternal toxicity and incompletely ossified sternebrae were observed in fetuses (at an incidence within the background historical range). In rabbits at 3 times the MRHD (1.5 mg/kg/day, subcutaneous), decreased maternal food consumption in the absence of any fetal effects was observed. Oral administration of 30 mg/kg/day fesoterodine to mice in a pre-and post-natal development study resulted in decreased body weight of the dams and delayed ear opening of the pups. No effects were noted on mating and reproduction of the F1 dams or on the F2 offspring.

Taking Fesoterodine While Breastfeeding

What are recommendations for lactation if you're taking Fesoterodine?

No information is available on the use of fesoterodine during breastfeeding. Long-term use of fesoterodine might reduce milk production or milk letdown. During long-term use, observe for signs of decreased lactation (e.g., insatiety, poor weight gain).

Maternal / infant drug levels

No information is available on the use of fesoterodine during breastfeeding. Long-term use of fesoterodine might reduce milk production or milk letdown. During long-term use, observe for signs of decreased lactation (e.g., insatiety, poor weight gain).

Possible effects of Fesoterodine on milk supply

Relevant published information in nursing mothers was not found as of the revision date. Anticholinergics can inhibit lactation in animals apparently by inhibiting growth hormone and oxytocin secretion.[1][2][3][4][5] Anticholinergic drugs can also reduce serum prolactin in nonnursing women.[6] The prolactin level in a mother with established lactation may not affect her ability to breastfeed.

Possible alternatives to Fesoterodine

None listed