Zaditor and Pregnancy
Based on animal studies on Zaditor, the risks of using the medication during pregnancy appear to be minimal. Since the full risks of using this eyedrop in pregnant humans are not known, however, you should not use it without talking to your healthcare provider. If you are already using Zaditor and pregnancy occurs, your healthcare provider will advise you based on your particular situation.
Zaditor® (ketotifen ophthalmic solution) is a non-prescription antihistamine eyedrop used to treat itching due to eye allergies. It is not known for certain if this medication is safe for use during pregnancy. However, based on animal studies, the risks to the fetus appear to be quite minimal.
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 that 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 ketotifen (the active ingredient in Zaditor) given by mouth to pregnant rabbits delayed the hardening of the sternum bone. In a similar study, giving extremely high doses of ketotifen to mother rats during pregnancy and breastfeeding seemed to slightly increase the risk of slow weight gain or death in the newborn rats.
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 a healthcare provider believes that the benefits to the woman outweigh any possible risks to the unborn child. This medication has not been adequately studied in pregnant humans, although serious problems are not generally expected, since very little of the medication actually reaches the bloodstream.