Nizatidine Pregnancy Warnings
Some animal studies have revealed evidence of abortions, decreased numbers of live fetuses, and decreased fetal weights at oral doses exceeding 275 mg/kg. There was 1 report of malformations (aortic arch coarctation, cardiac enlargement, cutaneous edema) in animal models given IV doses of 20 mg/kg, and 1 report of malformations (distended abdomen, enlarged heart, hydrocephaly, spina bifida, ventricular anomaly) in animal models given 50 mg/kg IV doses. IV 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 B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.
Use is recommended only if clearly needed and the benefit outweighs the risk to the fetus.
AU TGA pregnancy category: B3
US FDA pregnancy category: B
Comment: Some experts recommend limiting use to situations considered absolutely necessary in patients planning pregnancy, and then using this drug with caution.
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Nizatidine Breastfeeding Warnings
A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.
Excreted into human milk: Yes
Comments:
-The American Academy of Pediatrics has classified another agent of this drug class as compatible with breastfeeding.
-Pup growth depression was observed in lactating animal models treated with this drug.
-Other authorities have recommended the use of other histamine 2-antagonists with more extensive data (e.g., cimetidine, famotidine, ranitidine) in newborns.
Less than 0.1% of the maternal dose was eliminated in milk in proportion to plasma concentrations. In 3 women, the Cmax in excreted milk was approximately 1.2 mg/L nearly 2 hours after dosing, and the half-life of this drug in milk was less than 2 hours.
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