Optivar and Pregnancy

Animal studies on pregnancy and Optivar (azelastine ophthalmic solution) show that the medication could potentially be dangerous in pregnant women. When given to pregnant mice, high doses of the medication increased the risk of miscarriages, birth defects, and low fetal weight. Since Optivar has not been studied in pregnant women, however, the full risks to humans are not known.

Is Optivar Safe During Pregnancy?

Optivar® (azelastine ophthalmic solution) is a prescription antihistamine medication approved to treat eye allergy symptoms. Animal studies have shown that very high doses of the active ingredient in Optivar can increase the risk of miscarriages, birth defects, and other problems. However, the low Optivar dosage used in humans is probably unlikely to cause such problems.

Pregnancy Category C

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.
Optivar was given a pregnancy Category C rating because of problems seen in animal studies. When given to pregnant mice, extremely large doses of azelastine given orally increased the risk of miscarriages, birth defects (including cleft palate and missing tails or ribs), and low fetal weight. Similar results were seen in rats and rabbits. However, these doses were very high and resulted in blood levels of the drug that were up to 57,000 times higher than the levels that occur with use of Optivar.
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 pregnant 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, as very little of the medication actually reaches the bloodstream. However, the full risks are not currently known.
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