Ciprodex and Pregnancy
Although no research has been done specifically on pregnancy and Ciprodex (ciprofloxacin/dexamethasone), some studies have been done on the active ingredients in this ear medication. For example, in studies of pregnant rabbits, ciprofloxacin was shown to increase the risk of miscarriage. However, a healthcare provider can still prescribe the drug to a pregnant woman if the benefits outweigh the risks.
Ciprodex® (ciprofloxacin/dexamethasone) is a prescription ear drop used to treat certain ear infections. It contains a combination of ciprofloxacin, an antibiotic to cure the infection, and dexamethasone, a corticosteroid to help reduce inflammation.
Because Ciprodex is used in the ear, levels 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.
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.
Ciprodex has not been studied in pregnant women or in pregnant animals. However, ciprofloxacin, one of the active ingredients in the medication, did not 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 rats, mice, and rabbits. It did appear to increase the risk for miscarriage, however, in the pregnant rabbits.
There have been reported cases of birth defects in infants whose mothers took oral ciprofloxacin during pregnancy; however, one single type of defect does not seem to occur more often than any other. Therefore, it is difficult to tell if ciprofloxacin was actually the cause.
Dexamethasone, the other active ingredient in Ciprodex, is a corticosteroid medication. Some studies have shown an increased risk of cleft lip and cleft palate in infants whose mothers took oral corticosteroids, including dexamethasone, during pregnancy. Dexamethasone has been used late in pregnancy in women in premature labor, to help stimulate fetal lung development. When used for this reason, problems are rarely reported in the fetus or newborn babies.
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 only a very small amount of Ciprodex is expected to be absorbed from the ear into the bloodstream. Therefore, it is difficult to make any conclusions about Ciprodex use in pregnancy based on the information for oral ciprofloxacin and dexamethasone.