Sumatriptan (monograph) Pregnancy Warnings
Animal studies have revealed evidence of embryolethality, fetal abnormalities (decreased ossification, skeletal abnormalities, cervicothoracic vascular defects), decreased fetal body weight, and pup mortality. Embryolethality was most commonly reported in studies with rabbits at doses at or near those producing maternal toxicity. There are no controlled data in human pregnancy.
The first trimester use of sumatriptan in 1000 women has been reported during postmarketing surveillance. An increased risk of congenital defects was not observed; however, the data are insufficient to be conclusive. There are limited data on its use during the second and third trimesters.
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 only be given during pregnancy when benefit outweighs risk.
AU TGA pregnancy category: B3
US FDA pregnancy category: C
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Sumatriptan (monograph) Breastfeeding Warnings
Use with caution
Excreted into human milk: Yes (subcutaneous injection)
Comments:
-The effects in the nursing infant are unknown.
-Infant exposure can be minimized by avoiding breastfeeding for at least 8 to 12 hours after treatment with this drug.
Sumatriptan has poor oral bioavailability, decreasing infant exposure to the drug. Because of the low levels of sumatriptan in breastmilk, amounts ingested by the infant are small. Sumatriptan would not be expected to cause any adverse effects in most breastfed infants.
Peak milk level of sumatriptan averaged 87.2 mcg/L and occurred 2.5 hours after a single subcutaneous dose in 5 women who had been breastfeeding for 11 to 28 weeks. The mean half-life in milk was reported as 2.2 hours.
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