Antibiotic (Cephalosporin)
PREGNANCY RECOMMENDATION: Compatible
BREASTFEEDING RECOMMENDATION: Compatible
PREGNANCY SUMMARY
No detectable teratogenic risk with cefaclor and other cephalosporin antibiotics was found in a large 2001 study (see Cephalexin).
FETAL RISK SUMMARY
Cefaclor is an oral, semisynthetic cephalosporin antibiotic. Reproduction studies in mice, rats, and ferrets found no evidence of impaired fertility or fetal harm at doses up to 12, 12, and 3 times, respectively, the human dose (1). Cephalosporins are usually considered safe to use during pregnancy (see other cephalosporins for published human experience).
In a surveillance study of Michigan Medicaid recipients involving 229,101 completed pregnancies conducted between 1985 and 1992, 1325 newborns had been exposed to the antibiotic during the 1st trimester (F. Rosa, personal communication, FDA, 1993). A total of 75 (5.7%) major birth defects were observed (56 expected). Specific data were available for six defect categories, including (observed/expected) 19/13 cardiovascular defects, 8/2 oral clefts, 1/0.7 spina bifida, 1/4 polydactyly, 2/2 limb reduction defects, and 3/3 hypospadias. The data for all defects, cardiovascular defects, and oral clefts are suggestive of an association between cefaclor and congenital defects, but other factors, such as the mother’s disease, may be involved. However, similar findings were measured for another cephalosporin antibiotic with more than a thousand exposures (see Cephalexin). Positive results were also suggested for cephradine (339 exposures) but not for cefadroxil (722 exposures) (see Cephradine and Cefadroxil). In contrast, other anti-infectives with large cohorts (see Ampicillin, Amoxicillin, Penicillin G, Erythromycin, and Tetracycline) were not associated with congenital defects.
BREASTFEEDING SUMMARY
Cefaclor is excreted into breast milk in low concentrations. Following a single 500-mg oral dose, average milk levels ranged from 0.16 to 0.21 mcg/mL during a 5-hour period (2). Only trace amounts of the antibiotic could be measured at 1 and 6 hours. Even though these levels are low, 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.
In a 1993 cohort study, diarrhea was reported in 32 (19.3%) nursing infants of 166 breastfeeding mothers who were taking antibiotics (3). For the five women taking cefaclor, diarrhea was observed in 1 (20%) infants. The diarrhea was considered minor because it did not require medical attention (3).
Although not specifically listing cefaclor, the American Academy of Pediatrics classifies other cephalosporin antibiotics as compatible with breastfeeding (e.g., see Cefadroxil and Cefazolin).
References
1.Product information. Ceclor. Eli Lilly and Company, 1997.
2.Takase Z, Shirafuji H, Uchida M. Clinical and laboratory studies of cefaclor in the field of obstetrics and gynecology. Chemotherapy (Tokyo) 1979;27(Suppl):666–72.
3.Ito S, Blajchman A, Stephenson M, Eliopoulos C, Koren G. Prospective follow-up of adverse reactions in breast-fed infants exposed to maternal medication. Am J Obstet Gynecol 1993;168:1393–9.