Primaquine Pregnancy and Breastfeeding Warnings

Medically reviewed by Drugs.com. Last updated on Jul 31, 2023.

Primaquine Pregnancy Warnings

AU: Use of antimalarials to treat malaria is considered acceptable; the benefits to the mother and fetus outweigh the risk to the fetus.
US: This drug should not be used during pregnancy unless the benefit outweighs the risk to the fetus; safety has not been established during pregnancy.

AU TGA pregnancy category: D
US FDA pregnancy category: Not formally assigned to a pregnancy category.

Animal studies have not been reported. There are no controlled data in human pregnancy; no cases of congenital defects reported. This drug has been shown to cross the placenta.

There is a theoretical risk of hemolytic anemia in a glucose-6-phosphate dehydrogenase (G6PD)-deficient fetus. Some experts recommend that this drug be avoided in pregnancy because the G6PD status of the fetus cannot be determined.

AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details.

See references

Primaquine Breastfeeding Warnings

This drug should not be used unless the breastfeeding mother and infant have normal glucose-6-phosphate dehydrogenase (G6PD) levels.

Excreted into human milk: Yes (low levels)

Comments:
-If therapy is required, the mother and infant should be tested for G6PD deficiency before this drug is administered to a breastfeeding woman.
-The effects in the nursing infant are unknown.

In a trial, lactating mothers at risk for recurrent vivax malaria received 0.5 mg/kg/day. Preliminary results showed no drug-related side effects in their nursing infants (aged at least 28 days). Low but measurable levels of this drug were found in breast milk and infant plasma.

The very small amounts of antimalarial drugs transferred in breast milk are insufficient to provide adequate protection against malaria. If prophylaxis is required, infants should receive recommended doses of antimalarial drugs. Current guidelines should be consulted for additional information.

See references

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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