Risk Factor: C*
Class: Anti-infectives/ Aminoglycosides
Fetal Risk Summary
Amikacin is an aminoglycoside antibiotic. The drug causes dose-related nephrotoxicity in pregnant rats and their fetuses (1). Reproduction studies have been conducted in mice and rats and no evidence of impaired fertility or teratogenicity was observed (2).
The drug rapidly crosses the placenta into the fetal circulation and amniotic fluid (3,4,5 and 6). Studies in patients undergoing elective abortions in the 1st and 2nd trimesters indicate that amikacin distributes to most fetal tissues except the brain and cerebrospinal fluid (3,5). The highest fetal concentrations were found in the kidneys and urine. At term, cord serum levels were one-half to one-third of maternal serum levels whereas measurable amniotic fluid levels did not appear until almost 5 hours after injection (4).
No reports linking the use of amikacin to congenital defects have been located. Ototoxicity, which is known to occur after amikacin therapy in humans, has not been reported as an effect of in utero exposure. However, eighth cranial nerve toxicity in the human fetus is well known after exposure to other aminoglycosides (see Kanamycin and Streptomycin) and could potentially occur with amikacin.
[*Risk Factor D according to manufacturers, Astra USA and Elkins-Sinn, 1998.]
Breast Feeding Summary
Amikacin is excreted into breast milk in low concentrations. After 100- and 200-mg IM doses, only traces of amikacin could be found for 6 hours in two of four patients (4,7). Because oral absorption of this antibiotic is poor, ototoxicity in the infant would not be expected. However, three potential problems exist for the nursing infant: modification of bowel flora, direct effects on the infant, and interference with the interpretation of culture results if a fever workup is required.
- Mallie JP, Coulon G, Billerey C, Faucourt A, Morin JP. In utero aminoglycosides-induced nephrotoxicity in rat neonates. Kidney Inter 1988;33:3644.
- Product information. Amikacin. Elkins-Sinn, 2000.
- Bernard B, Abate M, Ballard C, Wehrle P. Maternal-fetal pharmacology of BB-K8. Antimicrobial Agents and Chemotherapy 14th Annual Conference: Abstract 71, 1974.
- Matsuda C, Mori C, Maruno M, Shiwakura T. A study of amikacin in the obstetrics field. Jpn J Antibiot 1974;27:6336.
- Bernard B, Abate M, Thielen P, Attar H, Ballard C, Wehrle P. Maternal-fetal pharmacological activity of amikacin. J Infect Dis 1977;135:92531.
- Flores-Mercado F, Garcia-Mercado J, Estopier-Jauregin C, Galindo-Hernandez E, Diaz-Gonzalez C. Clinical pharmacology of amikacin sulphate: blood, urinary and tissue concentrations in the terminal stage of pregnancy. J Int Med Res 1977;5;2924.
- Yuasa M. A study of amikacin in obstetrics and gynecology. Jpn J Antibiot 1974;27;37781.