Ciprofloxacin exposure not tied to miscarriage, major malformations: Study
Denmark: A recent study in the journal BJOG: An International Journal of Obstetrics & Gynaecology showed no link between maternal exposure to ciprofloxacin within the first 22 weeks of pregnancy and the risk of miscarriage and major malformations.
Ciprofloxacin is the antibiotic of choice for initial prophylactic therapy among asymptomatic pregnant women exposed to Bacillus anthracis, according to the US Food and Drug Administration (FDA). While, the FDA further states that, there have been no controlled studies of ciprofloxacin use in pregnant women to show safety. However, an expert review of published data on experiences with ciprofloxacin use during pregnancy by TERIS showed that t therapeutic doses during pregnancy are not likely to pose a substantial teratogenic risk, but there is insufficient data to state that there is no risk.
Against the above background, Mia Noergaard, Copenhagen University Hospital Bispebjerg and Frederiksberg, Copenhagen, Denmark, and colleagues aimed to examine the association between maternal exposure to ciprofloxacin and the risk of miscarriage and major malformations in a nationwide register-based cohort study.
For this purpose, the researchers obtained data from the Medical Birth Registry, the National Hospital Registry, the Danish National Prescription Registry, and Statistics Denmark between 1997-2016. It included all registered pregnancies that ended in an elective termination, miscarriage, stillbirth, or live birth. Exposure was defined as redeeming one or more prescriptions of ciprofloxacin.
Miscarriage was defined as a diagnosis given before 22 weeks without any medical intervention. According to EUROCAT 1.4, major malformations were classified. Ciprofloxacin-exposed pregnancies were matched o unexposed pregnancies on the propensity score in a ratio of 1:4. The hazard ratio (HR) of miscarriage was estimated. Also, the relative risk ratio (RR) of major malformations was estimated.
The study revealed the following findings:
- A total of 1,650,649 pregnancies were identified. Of these, 10,250 (2,050 ciprofloxacin exposed) and 6,100 (1,220 ciprofloxacin exposed) were included in the miscarriage and major malformation analysis, respectively.
- The HR of miscarriage was 0.99.
- For major malformation, the RR was 1.01.
- For the organ-specific major malformations and the sensitivity analyses, no significant increased risks were identified.
To conclude, there was no association between miscarriage and maternal ciprofloxacin exposure within the first 22 weeks of pregnancy, or major malformations and maternal exposure during the first trimester.
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