Ofloxacin and Pregnancy
Based on the results of animal studies, the Food and Drug Administration considers ofloxacin a pregnancy Category C medication. This means that although the drug is generally not recommended for use in pregnant woman, it could be prescribed if the benefits to the woman outweigh the possible risks to the unborn child. This might occur if other, more suitable antibiotics are not available.
Ofloxacin is a prescription antibiotic used to treat a variety of bacterial infections. It is available as a tablet, an ophthalmic (eye) solution, and an otic (ear) solution. Ofloxacin belongs to a group of medications called fluoroquinolones, or "quinolones" for short. At this time, it is not known if ofloxacin is 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.
In animal studies, ofloxacin did not appear to cause birth defects when given in high doses to pregnant rats and rabbits. However, it did appear to increase the risk for miscarriage and reduce fetal body weight. It also caused problems with fetal bone development in rats.
Ofloxacin has not been studied in pregnant women specifically. However, certain studies have looked at the effects of taking any oral fluoroquinolone, including ofloxacin, during pregnancy. Based on these studies, ofloxacin does not appear to increase the risk for one type of major birth defect. However, there is not enough information to determine if it is completely safe for pregnant women to take ofloxacin.
It is important to note that animals do not always respond to drugs 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 ofloxacin is necessary to treat an infection, the benefits may outweigh the potential risks.
It is also important to point out that the amount of ofloxacin expected to be absorbed into the body after use in the eyes or ears is quite small. Therefore, the potential risks of using the ophthalmic and otic solutions during pregnancy will likely be less than the risks associated with the use of oral ofloxacin.