Didronel Pregnancy Warnings
This drug has been shown to cause skeletal abnormalities in rats when given at oral dose levels 15 to 60 times the human dose. Other effects on the offspring (including decreased live births) are at dosages that cause significant toxicity in the parent generation, 25 to 200 times the human dose. There are no data on fetal risk in humans; however, there is a theoretical risk of fetal harm, predominantly skeletal, if a woman becomes pregnant after completing a course of bisphosphonate therapy. The impact of variables such as time between cessation of bisphosphonate therapy to conception, the particular bisphosphonate used, and the route of administration (intravenous vs. oral) on this risk has not been studied. There are no controlled data in human pregnancy.
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.
This drug should not be used during pregnancy unless the benefit outweighs the risk to the fetus.
TGA pregnancy category: B3
US FDA pregnancy category: C
Comments: This drug should not be used in women of childbearing potential unless adequate contraceptive measures are taken.
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