First trimester exposure to cefuroxime: a prospective cohort study

Aims There are no published studies on the safety of cefuroxime use during pregnancy. We therefore investigated prospectively the possible teratogenic effect of intrauterine exposure to cefuroxime. Methods One hundred and six women who received cefuroxime during the first trimester of pregnancy were...

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Bibliographic Details
Published in:British journal of clinical pharmacology 2000-08, Vol.50 (2), p.161-165
Main Authors: Berkovitch, Matitiahu, Segal‐Socher, Idit, Greenberg, Revital, Bulkowshtein, Mordechai, Arnon, Judy, Merlob, Paul, Or‐Noy, Asher
Format: Article
Language:English
Subjects:
Abnormalities, Drug-Induced
Abortion, Induced - psychology
Adolescent
Adult
Biological and medical sciences
cefuroxime
Cefuroxime - pharmacology
Cephalosporins - pharmacology
Confidence Intervals
Drug toxicity and drugs side effects treatment
Female
Humans
Infant
Infant, Newborn
Medical sciences
Miscellaneous (drug allergy, mutagens, teratogens...)
Pharmacology. Drug treatments
Pharmacovigilance
Pregnancy
Pregnancy Outcome
Pregnancy Trimester, First
Prospective Studies
Risk
teratogenicity
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Summary:Aims There are no published studies on the safety of cefuroxime use during pregnancy. We therefore investigated prospectively the possible teratogenic effect of intrauterine exposure to cefuroxime. Methods One hundred and six women who received cefuroxime during the first trimester of pregnancy were recruited from three teratogen information centres in Israel. Exposed women were paired for age, smoking habits and alcohol consumption with references being exposed to nonteratogenic antibiotics administered for the same indications. Results Maternal history, birthweight, gestational age at delivery, rates of live births, spontaneous abortions and fetal distress were comparable among the two groups. Rates of major malformations in the cefuroxime group (3.2%) did not differ from references (2%) (P = 0.61, relative risk = 1.56, 95% confidence interval 0.27–9.15). There was a significantly higher rate of induced abortions among the cefuroxime exposed women as compared to the references (P = 0.04, relative risk = 3.33, 95% confidence interval 0.94–11.77). Conclusions Our data may suggest that exposure to cefuroxime during the first trimester is probably not associated with an increased risk for malformations or spontaneous abortions; however, in light of the small sample size and the broad confidence limits, larger studies are needed to confirm these findings.
ISSN:0306-5251
1365-2125
DOI:10.1046/j.1365-2125.2000.00240.x