Floxin Otic and Pregnancy
The FDA has given Floxin Otic (ofloxacin otic solution) a pregnancy Category C rating. This means it may not be safe for use by women who are expecting. When high oral doses of the drug's active ingredient were given to pregnant animals, it increased the risk for miscarriages and birth defects. However, a healthcare provider may prescribe this drug if the benefits outweigh the risks.
Can Pregnant Women Use Floxin Otic?Floxin® Otic (ofloxacin otic solution) is an antibiotic ear drop used to treat certain ear infections. It belongs to a group of medications called fluoroquinolones, or just "quinolones" for short.
Because Floxin Otic is used in the ear, levels of the medication in the body are expected to be very low or nonexistent. Based on this information, this product is not thought to be particularly dangerous during pregnancy. However, all of the possible risks to humans are not known at this time.
What Is Pregnancy Category C?The U.S. Food and Drug Administration (FDA) uses a pregnancy 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.
Medicines that have not been studied in any pregnant women or animals are automatically given a pregnancy Category C rating.
Floxin Otic has not been studied in pregnant women or pregnant animals. However, ofloxacin (the active ingredient in Floxin Otic) decreased fetal body weight and increased the risk for miscarriages when given orally in very high doses to pregnant rats and rabbits. It also caused fetal skeletal problems in rats at high doses. Doses similar to those expected with topical ear use did not cause any problems in animal studies.
Studies have looked at pregnancy outcomes in women who took an oral fluoroquinolone while pregnant. Based on these studies, oral ofloxacin does not appear to increase the risk for any one type of major birth defect. However, there is not enough information to determine that it 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 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.
It is also important to point out that the amount of Floxin Otic expected to be absorbed into the bloodstream from the ear is very small. Therefore, it is difficult to make any conclusions about Floxin Otic use in pregnancy based on the information for oral ofloxacin.