Ocuflox and Pregnancy
The FDA has classified Ocuflox (ofloxacin ophthalmic solution) as a pregnancy Category C medication, which means it may be prescribed if the benefits outweigh the risks. In animal studies, the active ingredient in the drug was shown to increase the risk of problems such as miscarriage and reduced fetal weight when large oral doses were given. When used as an eye drop, problems are unlikely.
Ocuflox® (ofloxacin ophthalmic solution) is a prescription eye drop approved to treat bacterial conjunctivitis ("pink eye") and corneal ulcer infections. It belongs to a group of antibiotics called fluoroquinolones, or just "quinolones" for short.
Because Ocuflox is used in the eye, levels of the medication in the body are expected to be very low. Based on this information, this product is not thought to be particularly dangerous during pregnancy. However, all the possible risks are not known at this time. The manufacturer recommends that Ocuflox only be used in pregnancy if the potential benefits justify the potential risk to the fetus.
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.
Although Ocuflox has not been studied in pregnant women or animals, ofloxacin (the active ingredient in the drug) has been studied in pregnant animals. When given to pregnant rats and rabbits at very high doses (up to 9,000 times the maximum recommended daily eye dose), ofloxacin increased the risk for miscarriage and reduced fetal body weight. It also caused skeletal problems in the rat fetuses.
Studies have looked at oral fluoroquinolone use as a group in pregnant women. Based on these studies, ofloxacin does not appear to increase the risk for any major birth defects. However, there is not enough information to determine if this medication is completely safe for use in 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 drug may be given to pregnant women if the healthcare provider believes that the benefits to a woman outweigh any possible risks to the unborn child.
It is also important to point out that the amount of Ocuflox expected in the blood after use in the eye is very small -- more than 1,000 times lower than blood levels after normal oral doses. Therefore, it is difficult to make any conclusions about the use of Ocuflox in pregnancy from oral ofloxacin studies.