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Tiludronate Pregnancy and Breastfeeding Warnings

Tiludronate is also known as: Skelid

Tiludronate Pregnancy Warnings

Dose-related scoliosis likely attributable to the pharmacologic properties of this drug was reported in rabbits dosed with this drug during gestational period. In gestational mice, the administration of this drug showed slight maternal toxicity (decreased body weight gain), increased post-implantation loss, decreased number of fetuses, and decreased fetus body weight. Uncommon malformations of the paw (shortened or missing digits, blood blisters between or in place of digits) were also reported. Maternal toxicity (decreased body weight), reduced percent implantations, increased postimplantation loss, and increased intra-uterine deaths in the rats were observed. There were no teratogenic effects on fetuses. Protracted parturition and maternal death, presumably due to hypocalcemia, occurred when rats were treated from day 15 of gestation to day 25 postpartum. The impact of variables such as time between cessation of bisphosphonate therapy to conception, the particular bisphosphonate used, and the route of administration (intravenous versus oral) on this risk has not been established. There are no adequate and well-controlled studies in pregnant women. AU TGA pregnancy category B2: 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 are inadequate or may be lacking, but available data show no evidence of an increased occurrence of fetal damage. 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.

This drug should not be used during pregnancy unless the benefit outweighs the risk to the fetus. AU TGA pregnancy category: B2 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.

See references

Tiludronate Breastfeeding Warnings

AU: Use is not recommended. US: Caution is recommended. Excreted into human milk: Unknown Comments: The effects in the nursing infant are unknown.

There are no animal studies investigating the passage of this drug into the milk.

See references

References for pregnancy information

  1. "Product Information. Skelid (tilundronate)." Sanofi Winthrop Pharmaceuticals, New York, NY.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. Cerner Multum, Inc. "Australian Product Information." O 0

References for breastfeeding information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  2. "Product Information. Skelid (tilundronate)." Sanofi Winthrop Pharmaceuticals, New York, NY.
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  4. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL:" ([cited 2013 -]):

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