CEFIXIME

Fetal Risk Summary

Cefixime is an oral, semisynthetic cephalosporin antibiotic. Reproduction studies found no evidence in rats of impaired fertility or reproductive performance at doses up to 125 times the adult therapeutic dose or, in mice and rats, of teratogenicity at doses up to 400 times the human dose (1).

A 1998 noninterventional observational cohort study described the outcomes of pregnancies in women who had been prescribed one or more of 34 newly marketed drugs by general practitioners in England (2). Data were obtained by questionnaires sent to the prescribing physicians one month after the expected or possible date of delivery. In 831 (78%) of the pregnancies, a newly marketed drug was thought to have been taken during the 1st trimester with birth defects noted in 14 (2.5%) singleton births of the 557 newborns (10 sets of twins). In addition, two birth defects were observed in aborted fetuses. However, few of the aborted fetuses were examined. Cefixime was taken during the 1st trimester in 11 pregnancies. The outcomes of these pregnancies included two spontaneous abortions, one elective abortion, seven normal newborns (one premature), and one unknown outcome (2).

No other reports describing the use of cefixime in human pregnancy have been located. Cephalosporins are usually considered safe to use during pregnancy (see also other cephalosporins).

Breast Feeding Summary

No reports describing the use of cefixime during human lactation, or measuring the amount of the drug excreted in milk, have been located. Low concentrations of other cephalosporins have been measured, however, and the presence of cefixime in milk should be expected. Three potential problems exist for the nursing infant exposed to cefixime in milk: modification of bowel flora, direct effects on the infant, and interference with the interpretation of culture results if a fever workup is required. Although not specifically listing cefixime, the American Academy of Pediatrics classifies other cephalosporin antibiotics as compatible with breast feeding (3).

References

1. Product information. Suprax. Lederle Laboratories, 1997.
2. Wilton LV, Pearce GL, Martin RM, Mackay FJ, Mann RD. The outcomes of pregnancy in women exposed to newly marketed drugs in general practice in England. Br J Obstet Gynaecol 1998;105:882–9.
3. Committee on Drugs, American Academy of Pediatrics. The transfer of drugs and other chemicals into human milk. Pediatrics 1994;93:137–50.