Cephradine Pregnancy and Breastfeeding Warnings

Brand names: Velosef

Cephradine Pregnancy Warnings

Cephradine has been assigned to pregnancy category B by the FDA. Animal studies have failed to reveal evidence of fetal harm. There are no controlled data in human pregnancy. Cephradine should only be given during pregnancy when need has been clearly established.

There are no case reports of adverse effects of cephradine on the fetus. Data reveal that cephradine is more likely to produce significant and therapeutic fetal levels after 15 weeks gestation. In the first and second trimesters, intravenously or orally administered cephradine produces amniotic fluid levels of 1 mcg/mL or less. A 1 gram intravenous dose between weeks 15 and 30, however, produces amniotic fluid levels ranging from 3 to 15 mcg/mL within 50 minutes of administration.

The Michigan Medicaid surveillance study showed a possible association between cephradine and congenital defects. This report is a summary of information from two studies, one in which 239 of 104,000 pregnant women from 1980 to 1983, and one in which 339 of 229,000 pregnant women from 1985 to 1992 received cephradine. In the first study 20 total defects (3 cardiovascular defects) were observed (14 and 2 were expected, respectively). In the second study, 27 total defects (9 cardiovascular defects) were observed (14 and 3 were expected, respectively). Cleft palate was not observed in either study. These data support an association between cephradine and congenital defects, although other causes, such as the underlying disease(s) of the mother and concomitant drug therapy are unaccounted for.

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Cephradine Breastfeeding Warnings

Cephradine is excreted into human milk in small amounts. Adverse effects in the nursing infant are unlikely. Other cephalosporins have been classified as compatible with breast-feeding by the American Academy of Pediatrics.

No reports of adverse effects in the nursing infant are reported. After cephradine 500 mg orally every 6 hours for 48 hours, human milk levels of 0.6 mcg/mL are reported. The average milk to maternal serum level ratio is 0.2. While this level and ratio are extremely low, some experts warn of unknown direct effects on the nursing infant, modification of neonatal bowel flora, and difficulty in the interpretation of culture results in the evaluation of a suspected infection.

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Further information

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