Postmarketing surveillance of medications and pregnancy outcomes: Clarithromycin and birth malformations

Purpose - This retrospective surveillance study used linked administrative claims data and medical records to determine the rare and types of birth malformations in infants born to women exposed to the antibiotic, clarithromycin (Biaxin(R)), during the first trimester of pregnancy. Methods - Pharmacy and hospital claims from eight geographically diverse health plans were used to identify women who had a delivery claim within 270 days of a clarithromycin prescription over a 5-year period (1991-1995). Hospital delivery admission medical records for 143 mothers and their 149 infants were abstracted to identify birth malformations. Results - Five infants were identified with major malformations, three with minor malformations, and four with undescended testicles likely to resolve with time. The observed rate of 3.4% (95% CI, 0.5, 6.3) for major malformations was not statistically significantly different compared to an expected rate of 2.8% based on earlier national data. There was no consistency across types of major malformations. Conclusions - These results provide no evidence that clarithromycin is a likely major teratogen in humans. Use of claims data is one way to evaluate quickly and efficiently the safety of prescription medications in humans during pregnancy, especially when both exposure and outcome are rare. Copyright (C) 2000 John Wiley & Sons, Ltd.