Is Elestat Safe During Pregnancy?
Elestat® (
epinastine ophthalmic solution) is a prescription antihistamine medication used to prevent itching due to eye
allergies. It is not known if this medication is safe for use during pregnancy. However, based on animal studies, the risks appear to be minimal 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. Also, medicines that have not been studied in any pregnant women or animals are automatically given a pregnancy Category C rating.
Extremely high doses of epinastine (the active ingredient in Elestat) given by mouth to pregnant rats did not cause any problems for the fetus, even though the doses caused toxicity in the pregnant rats. These doses were about 150,000 times the equivalent recommended
Elestat dosage in humans. Lower doses (equivalent to 90,000 times the recommended human dose) did seem to cause decreased weight gain in the newborn rats, though. In a similar study, giving extremely high doses of epinastine to pregnant rabbits increased the risk of miscarriages.
It is important to note that animals do not always respond to medicines the same way that humans do. Therefore, a pregnancy Category C medicine may be given to a pregnant woman if a healthcare provider believes that the benefits to the pregnant woman outweigh any possible risks to the unborn child. This medication has not been adequately studied in pregnant humans, but serious problems are not generally expected (since very little of the medication actually reaches the bloodstream).
