Pregnancy outcome following gestational exposure to Azithromycin: a prospective controlled study

Abstract

Listen

Translate article

Introduction Azithromycin is an azalide antibiotic with an extensive range of indications including upper/lower respiratory tract ailments, skin, genitourinary infections etc. It is a popular treatment option due to its convenient dosing regimen and therapeutic advantages. Available human studies addressing gestational use of azithromycin have primarily focused on efficacy, rather than fetal safety. Objective: To evaluate pregnancy outcome following gestational exposure to azithromycin. Methods: This prospective controlled study consists of an azithromycin-exposed group compared to: 1) women receiving non-teratogenic antibiotics for similar indications and 2) exposed to non-teratogenic agents. The three groups were matched for gestational age at time of call, maternal age, smoking/alcohol status. Rates of major anomalies and secondary endpoints of interest were compared. Results: Pregnancy outcome was ascertained from a total of 123 women enrolled in each group. In the exposed group, 88 pregnancies occurred in the first trimester. Statistical analysis did not show any significant differences between the three groups in the rates of major malformations; 3.4% versus 2.3% and 3.4% (P=0.9) or any other endpoints that were examined. Conclusion: To date, results do not appear suggest an increased risk above baseline with gestational azithromycin exposure, providing an evidence-based option for health professionals caring for non-compliant populations with Chlamydia. Clinical Pharmacology & Therapeutics (2004) 75, P75–P75; doi: 10.1016/j.clpt.2003.11.283