What is the safety of Quinolones (Fluoroquinolones) in pregnancy?

From the Guidelines

Quinolone antibiotics can be used in pregnancy for serious infections when indicated, as the benefits may outweigh the potential risks, according to the most recent and highest quality study available 1.

Key Considerations

• Animal studies have shown that quinolones can cause arthropathy in developing fetuses, but human data suggests a low risk 1.
• Approximately 400 cases of quinolone use in human pregnancies have been reported to various pregnancy registries, and use has not been associated with human arthropathy or birth defects after in utero exposure 1.
• Safer alternative antibiotics, such as penicillins, cephalosporins, or nitrofurantoin, are typically preferred during pregnancy for urinary tract infections, while amoxicillin, amoxicillin-clavulanate, or certain macrolides may be used for respiratory infections.

Clinical Decision-Making

• Quinolones should only be considered during pregnancy when the benefits clearly outweigh the potential risks, such as in cases of severe infections where alternative antibiotics are ineffective or contraindicated.
• Any use of quinolones during pregnancy should involve careful consultation between the healthcare provider and patient, weighing the specific clinical situation against potential fetal risks.
• The most recent study available 1 suggests that ciprofloxacin may be a suitable option if a fluoroquinolone is indicated, due to its relatively low risk profile compared to other quinolones.

From the FDA Drug Label

Pregnancy Teratogenic Effects Pregnancy Category C: There are no adequate and well-controlled studies in pregnant women An expert review of published data on experiences with ciprofloxacin use during pregnancy by TERIS - the Teratogen Information System - concluded that therapeutic doses during pregnancy are unlikely to pose a substantial teratogenic risk (quantity and quality of data=fair), but the data are insufficient to state that there is no risk. Ciprofloxacin should not be used during pregnancy unless the potential benefit justifies the potential risk to both fetus and mother (see WARNINGS).

Key Points:

• Pregnancy Category C: No adequate and well-controlled studies in pregnant women.
• Teratogenic Risk: Therapeutic doses unlikely to pose a substantial teratogenic risk, but data are insufficient to confirm no risk.
• Use in Pregnancy: Ciprofloxacin should not be used during pregnancy unless the potential benefit justifies the potential risk to both fetus and mother 2.

From the Research

Quinolones Safety in Pregnancy

• The use of quinolones during pregnancy has been a topic of concern due to potential risks of fetal malformations and carcinogenesis in animals 3, 4.
• However, studies have shown that quinolones may not be associated with unfavorable pregnancy outcomes, such as fetal malformations, preterm delivery, stillbirth, or miscarriage 3.
• A meta-analysis found no association between quinolones and fetal malformations, with a pooled odds ratio of 1.08 (95% CI 0.96-1.21) 3.
• Another study found that children born to mothers treated with quinolones were significantly heavier than control infants, possibly due to better control of urinary tract infections 4.
• However, a more recent study found that quinolone use during the first trimester of pregnancy was associated with an increased risk of atopic dermatitis, asthma, and allergies in offspring 5.

Potential Risks and Considerations

• Quinolones have been associated with central nervous system side effects, photosensitivity reactions, and gastrointestinal side effects 6.
• The selection of quinolones depends on their safety profile, cost, and microbiologic activity 6.
• Resistance potential is highest with ciprofloxacin and lowest with levofloxacin 6.
• Levofloxacin is preferred for general use due to its minimal side effects, low resistance potential, and cost-effectiveness 6.

Clinical Implications

• Quinolones should not be used as a first-line therapy during the first trimester of pregnancy until larger studies establish their safety 3.
• Caution should be taken when prescribing quinolones during pregnancy, especially during the first trimester 3, 4.
• Physicians should consider alternative antibiotics when possible and weigh the benefits and risks of quinolone use during pregnancy 5, 6.