Floxin and Pregnancy
The Food and Drug Administration has given Floxin (ofloxacin) a pregnancy Category C rating because of the effects it had on the offspring of rats and rabbits. Although these results indicate that the medication should not be used by pregnant women, it may be prescribed if the benefits outweigh the risks, which may be the case with certain infections.
Floxin® (ofloxacin) is an antibiotic used to treat a variety of bacterial infections. It belongs to a group of drugs called fluoroquinolones, or sometimes "quinolones" for short. Based on the results of animal studies, this medication may not be safe for use during pregnancy.
The U.S. Food and Drug Administration (FDA) uses a category system to classify the possible risks to a fetus when a specific medicine is taken during pregnancy. Pregnancy Category C is given to medicines that have not been studied in pregnant humans but do appear to cause harm to the fetus in animal studies.
In addition, medicines that have not been studied in any pregnant women or animals are automatically given a pregnancy Category C rating.
When given to pregnant rats and rabbits at very high doses, Floxin did not appear to cause birth defects. However, it did appear to increase the risk for miscarriage and reduce fetal body weight in both rats and rabbits, as well as cause fetal bone changes in rats.
Although Floxin has not been studied adequately in pregnant women, studies have looked at pregnancy outcomes in women who took fluoroquinolones in general, including Floxin, during pregnancy. Based on these studies, Floxin does not appear to increase the risk for any major birth defects. However, there is not enough information to say that it is completely safe for use during pregnancy.
It is important to note that animals do not always respond to medicines in the same way that humans do. Therefore, a pregnancy Category C medicine may be given to a pregnant woman if the healthcare provider believes that the benefits to the woman outweigh any possible risks to the unborn child. If other, more suitable, antibiotics are not an option and Floxin is necessary to treat an infection, the benefits of use may outweigh the potential risks.