Olanzapine Pregnancy and Breastfeeding Warnings

Olanzapine is also known as: Zyprexa, Zyprexa Intramuscular, Zyprexa Relprevv, Zyprexa Zydis

Olanzapine Pregnancy Warnings

A study analyzing 23 prospectively and 11 retrospectively olanzapine-exposed pregnancies found that the rates for spontaneous abortion, stillbirth, prematurity, and malformation fell within the control range. Several additional cases of healthy infants born to olanzapine-treated mothers have also been reported.

Olanzapine has been assigned to pregnancy category C by the FDA. Some animal studies have revealed evidence of fetotoxicity at 9 times the maximum human dose on a mg/m2 basis. There are no controlled data in human pregnancy. Neonates exposed to antipsychotic drugs during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery. There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress and feeding disorder in these neonates. These complications have varied in severity; while in some cases symptoms have been self-limited, in other cases neonates have required intensive care unit support and prolonged hospitalization. Olanzapine is only recommended for use during pregnancy when there are no alternatives and benefit outweighs risk.

Olanzapine Breastfeeding Warnings

Olanzapine is excreted into human milk. A study involving lactating, healthy women reported a mean infant dose at steady-state of approximately 1.8% of the maternal olanzapine dose. Adverse effects (which may not have been caused by the olanzapine) have been described in one nursing infant. The manufacturer recommends that breast-feeding be avoided in women receiving olanzapine.

Two cases of exposure to olanzapine during lactation have been reported. One infant experienced adverse effects which continued after olanzapine was discontinued, suggesting an alternate cause. No problems were reported in the other infant. A study involving 7 mother-infant nursing pairs in which the mother received olanzapine at an average daily dose of 7.5 mg (range = 5 to 20 mg) reported a median infant dose ingested from the milk of approximately 1.02% of the maternal dose. Six infants had olanzapine plasma levels below the detectable level. All infants remained healthy and failed to show signs or symptoms of adverse effects. The maximum olanzapine concentration in the milk was shown to be delayed from the corresponding maximum maternal plasma level; therefore, infant exposure may possibly be reduced by avoiding breast-feeding for approximately 5 hours after olanzapine administration. However, the authors recommend all breast-fed infants of mothers receiving olanzapine be monitored closely and the decision to breast-feed only be made if the benefit outweighs the risk.

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