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Risedronate Pregnancy and Breastfeeding Warnings

Risedronate is also known as: Actonel, Atelvia

Risedronate Pregnancy Warnings

Bisphosphonates are incorporated into the bone matrix, from where they are gradually released over periods of weeks to years. Therefore, there is a theoretical risk of fetal harm if a woman becomes pregnant after completing a course of bisphosphonate therapy. Animal studies using risedronate have revealed evidence of maternal toxicity and male and embryo/fetal effects at doses 1 to 27 times the recommended human dose based on body surface area (BSA). Animal studies (rats) using risedronate at doses 1 time the recommended human dose based on body surface area (BSA) during mating and gestation resulted in periparturient hypocalcemia and mortality in pregnant females allowed to deliver. Neonate survival decreased during gestation at doses 5 to 27 times the recommended human dose (BSA). Body weight in neonates treated with 2 to 5 times the recommended human dose (BSA) increased, but decreased at doses 27 times recommended human dose. Treatment at 1 time the recommended human dose based on BSA resulted in a decrease of incomplete ossification of sternebrae or skull of fetuses. However, doses 2 times the recommended human dose during gestation resulted in an increase of incomplete ossification of sternebrae or skull of fetuses. Unossified fetal sternebrae decreased at both dosages. Doses 5 to 27 times the recommended human dose (BSA) resulted in an increase in both incomplete ossification and unossified sternebrae. A low incidence of cleft palette was observed in fetuses from females treated with 1 to 2 times the recommended human dose (BSA). The relevance to human use has not been established. Animal studies (rabbits) using risedronate at doses up to 7 times the recommended human dose (BSA) did not reveal significant fetal ossification effects. However, 1 litter (1/14) was aborted and 1 (1/14) was delivered prematurely. Animal studies (rats) using doses 5 times the recommended human dose (BSA) resulted in inhibition of ovulation in females. Doses 2 to 5 times the recommended human dose resulted in decreased implantation. In male rats, testicular and epididymal atrophy and inflammation were observed at doses 13 times the recommended human dose. Testicular atrophy occurred at week 13 of treatment at doses 5 times the human recommended dose. In male dogs, doses 8 times the recommended human dose resulted in moderate to severe spermatid maturation block after 13 weeks of therapy. Animal fertility impairment findings tended to increase in severity with increased dose and exposure time.

Risedronate has been assigned to pregnancy category C by the FDA. Animal studies have revealed fetal harm. There are no controlled data in human pregnancy. Risedronate is only recommended for use during pregnancy when there are no alternatives and benefit outweighs risk.

Risedronate Breastfeeding Warnings

There are no data on the excretion of risedronate into human milk. The manufacturer recommends that due to the potential for serious adverse reactions in nursing infants, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

Risedronate was detected in feeding pups exposed to lactating rats, indicating a small amount of lacteal transfer.

See Also...

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