Risedronate Pregnancy and Breastfeeding Warnings
Risedronate Pregnancy Warnings
Animal studies have shown that this drug crosses the placenta to a minimal extent in rats. The drug had no teratogenic activity in rats or rabbits. Survival of neonates was decreased in rats treated during gestation with oral doses approximately 5 times the human dose and body weight was decreased in neonates from dams treated with approximately 26 times the human dose. Incomplete ossification and unossified sternebrae were increased in rats treated with oral doses approximately 5 times the human dose. A low incidence of cleft palate was observed in fetuses from female rats treated with oral doses approximately equal to the human dose. Treatment during mating and gestation with doses of this drug approximately the same as the 30 mg/day human dose resulted in periparturient hypocalcemia and mortality in rats allowed to deliver. Animal studies in rats 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. 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. There are no data on fetal risk in humans. There are no adequate and well-controlled studies of this drug in pregnant women. 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.
UK: Use is contraindicated. AU, US: This drug should not be used during pregnancy unless the benefit outweighs the risk to the fetus. AU TGA pregnancy category: B3 US FDA pregnancy category: C Comment: There is a theoretical risk of fetal harm, predominantly skeletal, if a woman becomes pregnant after completing a course of bisphosphonate therapy.
Risedronate Breastfeeding Warnings
UK: Use is contraindicated. AU, US: 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: Yes Excreted into animal milk: Unknown Comments: The effects in the nursing infant are unknown.
References for breastfeeding information
- Cerner Multum, Inc. "Australian Product Information." O 0
- Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
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