NDA 17-037/S-158
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Carcinogenesis, Mutagenesis, Impairment Of Fertility
No long-term studies in animals have been performed to evaluate the carcinogenic potential of heparin
sodium. Also, no reproduction studies in animals have been performed concerning mutagenesis or
impairment of fertility.
Pregnancy
Teratogenic Effects—Pregnancy Category C
Animal reproduction studies have not been conducted with heparin sodium. It is also not known
whether heparin sodium can cause fetal harm when administered to a pregnant woman or can affect
reproduction capacity. Heparin sodium should be given to a pregnant woman only if clearly needed.
Nonteratogenic Effects
Heparin does not cross the placental barrier.
Nursing Mothers
Heparin is not excreted in human milk.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established. Not for use in neonates (see
WARNINGS).
Geriatric Use
A higher incidence of bleeding has been reported in patients over 60 years of age, especially women
(see
CLINICAL PHARMACOLOGY and
PRECAUTIONS,
General).
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