Is Pataday Safe During Pregnancy?
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.
Pataday and 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 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.
