Cephalexin Pregnancy Warnings

Cephalexin crosses the human placenta. In one study of 30 pregnant women who were given
cephalexin 1 gram orally once, the average peak umbilical cord and amniotic drug levels
were 11.3 (four hours after dosing) and 13.2 mcg/mL (six hours after dosing), respectively.
The Michigan Medicaid surveillance study showed a possible association between cephalexin
and congenital defects. This report is a summary of information from two studies, one in
which 1,705 of 104,000 pregnant women from 1980 to 1983, and one in which 3,613 of
229,000 pregnant women from 1985 to 1992 received cephalexin. In the first study, 127 total
defects and 19 cardiovascular defects were observed (122 and 16 were expected,
respectively). In the second study, 176 total defects were observed (154 expected), of which
44 were cardiovascular in nature (36 expected). Cleft palate was observed once in the first
study and 11 times in the second. These data support an association between cephalexin and
congenital defects, although other causes, such as the underlying disease(s) of the mother and
concomitant drug therapy are unaccounted for.
Cephalexin has been assigned to pregnancy category B by the FDA. Animal studies have
failed to reveal evidence of fetotoxicity or teratogenicity. There are no controlled data in
human pregnancy. However, the drug has been used in various stages of pregnancy without
evidence of fetal harm. Cephalexin should only be given during pregnancy when need has
been clearly established.

Cephalexin Breastfeeding Warnings

In one study of six women who received cephalexin 1 gram orally, the average peak milk
level was 0.51 mcg/mL between four and five hours after dosing. The average milk-tomaternal plasma drug level ratios were 0.008, 0.021, and 0.140 at 1, 2, and 3 hours after
dosing, respectively. While these levels are extremely low, some experts warn of possible
unknown direct risk to breast-feeding infants, modification of neonatal bowel flora, and
difficulty in interpreting culture results in the evaluation of a suspected infection.
Cephalexin is excreted into human milk in small amounts, although adverse effects are
unlikely in the nursing infant. Other cephalosporins have been classified as compatible with
breast-feeding by the American Academy of Pediatrics.