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Antimicrobial Agents and Chemotherapy, June 1998, p. 1336-1339, Vol. 42, No. 6
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.
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
*
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.
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