Allergies Home > Patanol and Pregnancy

In animal studies on Patanol (olopatadine ophthalmic solution) and pregnancy, high doses of the medication appeared to decrease the number of live fetuses. As a result, the FDA has classified it as a pregnancy Category C medication, which means it may not be safe. However, because the complete risks are unknown, your healthcare provider will weigh the benefits and risks before making a recommendation.

Is Patanol Safe During Pregnancy?

Patanol® (olopatadine ophthalmic solution) is a prescription antihistamine medication used to treat eye allergies. It is not known if this medication is safe for use during pregnancy.

Patanol 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.
Patanol was given a pregnancy Category C rating because of problems seen in animal studies. Although olopatadine (the active ingredient) did not seem to cause birth defects, it did decrease the number of live fetuses. However, this 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 the 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 expected, as very little of the medication actually reaches the bloodstream. However, the full risks are not currently known.
Written by/reviewed by:
Last reviewed by: Kristi Monson, PharmD;
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