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Antimicrobial Agents and Chemotherapy, June 1998, p. 1336-1339, Vol. 42, No. 6
0066-4804/98/$04.00+0
Copyright © 1998, American Society for Microbiology. All rights reserved.

Pregnancy Outcome Following Gestational Exposure to Fluoroquinolones: a Multicenter Prospective Controlled Study

Ronen Loebstein,1 Antonio Addis,1,2 Elaine Ho,1 Roseann Andreou,1 Suzanne Sage,3 Alan E. Donnenfeld,4 Betsy Schick,4 Maurizio Bonati,2 Myla Moretti,1 Arieh Lalkin,1 Anne Pastuszak,1 and Gideon Koren1,*

Motherisk Program, Toronto, Ontario, Canada1; Teratogen Information Service, Tampa, Florida3; Philadelphia Pregnancy Healthline, Philadelphia, Pennsylvania4; and Instituto di Recerche Farmacologiche Mario Negri, Centro Regionale d'Informazione sul Farmaco, Milan, Italy2

Received 26 November 1997/Returned for modification 15 February 1998/Accepted 19 March 1998

Concerns regarding the teratogenicity of fluoroquinolones have resulted in their restricted use during gestation. This is despite an increasing need for their use due to emerging bacterial resistance. The objectives of the present investigation were to evaluate pregnancy and fetal outcomes following maternal exposure to fluoroquinolones and to examine whether in utero exposure to quinolones is associated with clinically significant musculoskeletal dysfunctions. We prospectively enrolled and followed up 200 women exposed to fluoroquinolones (norfloxacin, ciprofloxacin, ofloxacin) during gestation. Pregnancy outcome was compared with that for 200 controls matched for age and for smoking and alcohol consumption habits. Controls were exposed to nonteratogenic, nonembryotoxic antimicrobial agents matched by indication, duration of therapy (±3 days), and trimester of exposure. Rates of major congenital malformations did not differ between the group exposed to quinolones in the first trimester (2.2%) and the control group (2.6%) (relative risk, 0.85; 95% confidence interval, 0.21 to 3.49). Women treated with quinolones had a tendency for an increased rate of therapeutic abortions compared with the rate among women exposed to nonteratogens (relative risk, 4.50; 95% confidence interval, 0.98 to 20.57), resulting in lower live-birth rates (86 versus 94%; P = 0.02). The rates of spontaneous abortions, fetal distress, and prematurity and the birth weight did not differ between the groups. Gross motor developmental milestone achievements did not differ between the children of the mothers in the two groups. We concluded that the use of fluoroquinolones during embryogenesis is not associated with an increased risk of major malformations. There were no clinically significant musculoskeletal dysfunctions in children exposed to fluoroquinolones in utero. The higher rate of therapeutic abortions observed in quinolone-exposed women compared to that for their controls may be secondary to the misperception of a major risk related to quinolone use during pregnancy.


* Corresponding author. Mailing address: Division of Clinical Pharmacology and Toxicology, The Hospital for Sick Children, Toronto, Ontario, Canada M5G 1X8. Phone: (416) 813-5781. Fax: (416) 813-7562. E-mail: felpharm{at}sickkids.on.ca.


Antimicrobial Agents and Chemotherapy, June 1998, p. 1336-1339, Vol. 42, No. 6
0066-4804/98/$04.00+0
Copyright © 1998, American Society for Microbiology. All rights reserved.



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