Tinzaparin Pregnancy and Breastfeeding Warnings

Tinzaparin is also known as: Innohep

Tinzaparin Pregnancy Warnings

Tinzaparin has been assigned to pregnancy category B by the FDA. Animal studies have not revealed evidence of teratogenicity. Cases of teratogenic effects have been reported in the literature involving infants of women who received tinzaparin during pregnancy; however, the manufacturer states that tinzaparin does not cross the placenta (based on human and animal data) and shows no evidence of teratogenic effects or fetotoxicity. There are no controlled data in human pregnancy. Tinzaparin does not appear to cross the placenta. Tinzaparin is only recommended for use during pregnancy when benefit outweighs risk.

One case each of cleft palate, optic nerve hypoplasia, and trisomy 21 syndrome have been reported in infants whose mothers received tinzaparin therapy during pregnancy. There have been four reports of fetal death/miscarriage in pregnant women who received tinzaparin. This also included pregnant women with a history of spontaneous abortion and/or high risk. Six percent of pregnancies were complicated by fetal distress. Side effects including congenital anomaly, fetal death, and fetal distress (all greater than 1.5%) have been reported. Other side effects including neonatal hypotonia have been reported in ongoing or completed clinical trials or from post marketing experience. In a study involving pregnant women (n=54) receiving tinzaparin for the treatment of venous thromboembolism or for thromboprophylaxis, doses of 50 to 175 anti-Xa units/kg once daily subcutaneously were well tolerated and no neonatal adverse events relating to tinzaparin were reported.

Tinzaparin Breastfeeding Warnings

Very low levels of tinzaparin have been reported in the breast milk of lactating animals.

There are no data on the excretion of tinzaparin into human milk. The manufacturer recommends that caution be used when administering tinzaparin to nursing women.

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