Tiludronate Pregnancy and Breastfeeding Warnings

Brand names: Skelid

Tiludronate Pregnancy Warnings

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.

Dose-related scoliosis likely attributable to the pharmacologic properties of this drug was reported in rabbits dosed with this drug during the 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.

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