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Nalidixic acid Pregnancy and Breastfeeding Warnings

Nalidixic acid is also known as: NegGram

Nalidixic acid Pregnancy Warnings

Nalidixic acid has been assigned to pregnancy category C by the FDA. Animal studies have revealed teratogenic and embryocidal effects and prolonged pregnancy duration. There are no controlled data in human pregnancy. No birth defects were reported in 63 newborns whose mothers had taken the drug during pregnancy. Cartilage damage and arthropathy are reported in immature animals giving rise to concern over effects on bone formation in the developing fetus. Because safer alternatives are available, some experts consider quinolones contraindicated during pregnancy, especially during the first trimester. Nalidixic acid is only recommended for use during pregnancy when benefit outweighs risk.

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Nalidixic acid Breastfeeding Warnings

Nalidixic acid is excreted into human milk in small amounts (0.003% of the maternal dose). Hemolytic anemia has been reported in an infant with G6PD deficiency. The manufacturer considers nalidixic acid to be contraindicated during lactation.

See references

References for pregnancy information

  1. Briggs GG, Freeman RK, Yaffe SJ.. "Drugs in Pregnancy and Lactation. 5th ed." Baltimore, MD: Williams & Wilkins (1998):
  2. "Product Information. NegGram (nalidixic acid)." Sanofi Winthrop Pharmaceuticals, New York, NY.

References for breastfeeding information

  1. Belton EM, Jones RV "Haemolytic anaemia due to nalidixic acid." Lancet 2 (1965): 691
  2. Briggs GG, Freeman RK, Yaffe SJ.. "Drugs in Pregnancy and Lactation. 5th ed." Baltimore, MD: Williams & Wilkins (1998):
  3. Committee on Drugs, 1992 to 1993 "The transfer of drugs and other chemicals into human milk." Pediatrics 93 (1994): 137-50
  4. "Product Information. NegGram (nalidixic acid)." Sanofi Winthrop Pharmaceuticals, New York, NY.
  5. Roberts RJ, Blumer JL, Gorman RL, et al "American Academy of Pediatrics Committee on Drugs: Transfer of drugs and other chemicals into human milk." Pediatrics 84 (1989): 924-36

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