Cipro HC and Pregnancy
Based on the results of animal studies, the Food and Drug Administration has classified Cipro HC as a pregnancy Category C medication. This does not mean that it absolutely cannot be used during pregnancy, just that the full risks the drug may present are unknown. If you become pregnant while taking it, your healthcare provider will consider the benefits and risks in your particular situation.
Can Pregnant Women Use Cipro HC?Cipro® HC (ciprofloxacin/hydrocortisone) is a prescription ear drop used to treat otitis externa, also known as "outer ear infections" and "swimmer's ear." It contains a combination of ciprofloxacin, an antibiotic, and hydrocortisone, a corticosteroid.
Because this medication is used in the ear, levels in the body are expected to be very low or nonexistent. Based on this information, the drug is not thought to be particularly dangerous during pregnancy. However, all of Cipro HC's 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 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.
Cipro HC has not been studied in pregnant women or pregnant animals. However, ciprofloxacin, one of the active ingredients in the medication, 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 to pregnant mice and rats (up to six times the usual human oral dose), it did appear to increase the risk for miscarriage when given to 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.
In animal studies, hydrocortisone, the other active ingredient in Cipro HC, caused birth defects and other problems in the offspring, including:
- Cleft palate
- Kidney disease
Problems were more likely to occur at higher hydrocortisone doses. In humans, hydrocortisone appears to slightly increase the risk for cleft lip and decrease infant birth weight when used during 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 pregnant women 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 Cipro HC expected to be absorbed from the ear is very small. Therefore, it is difficult to make any conclusions about pregnancy based on information for oral ciprofloxacin and hydrocortisone.