Risedronate Pregnancy and Breastfeeding Warnings

Brand names: Actonel, Atelvia

Medically reviewed by Drugs.com. Last updated on Nov 13, 2023.

Risedronate Pregnancy Warnings

Daily administration to pregnant rats during organogenesis decreased neonatal survival and weight at doses approximately 5 and 26 times the highest recommended human daily dose, respectively. There was a low incidence of cleft palate in fetuses of dams treated with doses approximately equal to the human daily dose. Fetuses of dam treated with approximately 2.5 to 5 times the 30 mg human dose showed delayed skeletal ossification. Following treatment, bisphosphonates are incorporated into the bone matrix and are gradually released over a period of years. The amount of bisphosphonate available for release into the systemic circulation is directly related to the dose and duration of bisphosphonate treatment. In pregnant women, the impact of bisphosphonate therapy prior to conception is unknown. 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 Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

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: Not assigned

Risk summary: There is insufficient data to inform a drug-associated risk of adverse maternal or fetal outcomes; based on bisphosphonate's mechanism of action, there is a theoretical risk of fetal harm, predominantly skeletal, if a woman becomes pregnant after completing a course of bisphosphonate therapy.

Comments: Most authorities advise drug discontinuation once pregnancy is detected.

See references

Risedronate Breastfeeding Warnings

Benefit should outweigh risk

Excreted into human milk: Unknown
Excreted into animal milk: Yes

Comments:
-The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for this drug and any potential adverse effects to the breastfed infant from the drug or from the underlying maternal condition.
-Some authorities advise against breastfeeding during use.

Studies in rat pups indicate a small degree of lacteal transfer. This drug is poorly absorbed orally so absorption by a breastfed infant is unlikely, however, due to lack of information, an alternate drug may be preferred.

See references

Further information

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