Cetraxal and Pregnancy
Although it hasn't been studied in pregnant women, Cetraxal (ciprofloxacin ear drops) is not believed to pose any serious risks to the mother or the fetus when taken during pregnancy. However, since not all of the risks are known, it's still important to talk to your healthcare provider about your specific situation before using this drug.
Can Pregnant Women Use Cetraxal?
Cetraxal® (ciprofloxacin ear drops) is a prescription medication used to treat outer ear infections, sometimes called "swimmer's ear." Because this medication is used in the ear, levels in the body are expected to be very low or nonexistent.
Based on this information, Cetraxal is not thought to be particularly dangerous during pregnancy. However, all the possible risks are not known at this time.
What Is Pregnancy Category C?
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.
Cetraxal has not been studied in pregnant women or in pregnant animals. However, ciprofloxacin, the active ingredient in Cetraxal, has been studied in pregnant rats, mice, and rabbits. Although it did not appear to cause birth defects or other problems in the offspring when given in high doses (up to six times the usual human oral dose) to pregnant mice and rats, it did appear to increase the risk for miscarriage in pregnant rabbits.
There have been cases of birth defects in infants whose mothers took oral ciprofloxacin during pregnancy; however, one single type of defect does not appear to stand out as occurring more often. Therefore, it is difficult to tell if ciprofloxacin actually caused the birth defects.
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 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 Cetraxal expected to be absorbed from the ear is very small, if any at all. Therefore, it is difficult to make any conclusions about Cetraxal use in pregnancy based on oral ciprofloxacin information.