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Tiludronate Pregnancy and Breastfeeding Warnings

Tiludronate is also known as: Skelid

Tiludronate Pregnancy Warnings

Animal studies using tiludronate at doses 2 times the recommended human dose based on body surface area (BSA) beginning day 15 of gestation to day 25 postpartum resulted in protracted parturition and maternal death thought to be due to hypocalcemia. Dosages 2 to 5 times the recommended human dose (BSA) during days 6-18 of gestation resulted in dose-related scoliosis attributed to the pharmacologic properties of the drug. Slight maternal toxicity (decreased weight gain), increased postimplantation loss, decreased fetal numbers and body weight occurred at doses 7 times the recommended human dose (BSA) during days 6-15 of gestation. Paw malformations (shortened or missing digits, blood blisters between or in place of digits) occurred in six fetuses from the same litter. Doses 10 times the recommended human dose (BSA) days 6-15 of gestation resulted in maternal toxicity (decreased body weight), reduced percentage of implantation, increased postimplantation loss, and increased intra-uterine deaths. Evidence of teratogenicity was not noted.

Tiludronate has been assigned to pregnancy category C by the FDA. Animal studies using tiludronate have revealed maternal toxicity and fetal effects at doses 2 to 10 times the recommended human dose based on body surface area (BSA). There are no controlled data in human pregnancy. Tiludronate is only recommended for use during pregnancy when there are no alternatives and benefit outweighs risk.

Tiludronate Breastfeeding Warnings

Caution is recommended. Excreted into human milk: Unknown Excreted into animal milk: Unknown The effects in the nursing infant are unknown.

Tiludronate is highly bound to calcium and poorly absorbed orally, so absorption by a breastfed infant is unlikely. An alternative drug may be preferred though, since no information exists on its use during breastfeeding.

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