Related Experiment Videos
Ciprofloxacin: toxicologic evaluation of additional safety data.
1Institut für Toxikologie, Bayer AG, Wuppertal, Federal Republic of Germany.
The American Journal of Medicine
|November 30, 1989
Summary
Long-term ciprofloxacin toxicology studies in rats and mice showed no systemic toxicity or tumorigenic effects. Further research indicated no embryotoxicity or teratogenicity in monkeys and minimal central nervous system interaction risks at high doses.
Area of Science:
- Pharmacology
- Toxicology
- Drug Safety
Background:
- Ciprofloxacin is a widely used fluoroquinolone antibiotic.
- Understanding its long-term safety profile, including potential toxicities, is crucial for clinical practice.
Purpose of the Study:
- To evaluate the long-term systemic toxicity and tumorigenic potential of ciprofloxacin.
- To investigate the arthropathogenic effects of ciprofloxacin in juvenile animals.
- To assess the embryotoxic and teratogenic potential of ciprofloxacin in non-human primates.
- To examine the central nervous system (CNS) interaction toxicology of ciprofloxacin with nonsteroidal anti-inflammatory drugs (NSAIDs).
Main Methods:
- Long-term oral administration of ciprofloxacin in rats and mice.
- Magnetic resonance imaging (MRI) in juvenile dogs to assess arthropathogenic effects.
- Oral and parenteral administration of ciprofloxacin in cynomolgus monkeys to evaluate embryotoxicity.
- CNS interaction studies in rats involving co-administration of ciprofloxacin and NSAIDs.
Main Results:
- Long-term studies in rats and mice (up to 24 months) revealed no systemic toxicity or evidence of tumorigenicity.
- In juvenile dogs, MRI showed increased recessus suprapatellaris width only in cases with marginal arthropathic effects, suggesting MRI's utility in monitoring.
- Embryotoxicity studies in cynomolgus monkeys indicated no teratogenicity or embryolethality, with similar progesterone levels across groups.
- CNS interaction toxicity between ciprofloxacin and NSAIDs was observed in rats only at therapeutically irrelevant high doses.
Conclusions:
- Ciprofloxacin demonstrates a favorable long-term safety profile with no systemic toxicity or tumorigenic potential.
- MRI may be a valuable tool for monitoring potential joint-related side effects in juvenile patients.
- Ciprofloxacin is not teratogenic or embryolethal in cynomolgus monkeys.
- Clinically significant CNS interaction between ciprofloxacin and NSAIDs is unlikely at therapeutic doses.