Pataday and Pregnancy
No human studies have been conducted on pregnancy and Pataday. However, serious problems are not expected to occur when the eyedrop is used by pregnant women because very little of the medication actually reaches the bloodstream. If you become pregnant while using Pataday, talk to your healthcare provider about the benefits and potential risks.
Pataday™ (olopatadine ophthalmic solution) is a prescription antihistamine medication used to treat itching due to eye allergies. It is not known if this medication is safe for use during pregnancy, although the risks appear to be minimal at this time.
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.
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.
Pataday was given a pregnancy Category C rating because of problems seen in animal studies. Although olopatadine (the active ingredient in Pataday) did not seem to cause birth defects, it did decrease the number of live fetuses and, when taken during late pregnancy and during lactation, decreased the weight and survival of the newborn animals. However, these problems occurred only at extremely large doses (equivalent to up to 93,750 times the recommended human dose).
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.