In animal studies on pregnancy and Alaway, the medication slightly increased the risk of slow weight gain or death in newborns when it was given in high doses to pregnant rats. However, it is important to know that animals do not always respond to drugs the same way that humans do. If you are using this drug and pregnancy occurs, talk to your healthcare provider.
Is It Safe to Take Alaway During Pregnancy?
Alaway® (ketotifen ophthalmic solution) is an over-the-counter eye drop used for the treatment of eye allergies. It is an antihistamine medication. While it is not known for certain if this medication is safe for use during pregnancy, the risks to the fetus appear to be quite minimal.
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.
Giving extremely high doses of ketotifen (the active ingredient in Alaway) to the mother rats during pregnancy and breastfeeding seemed to slightly increase the risk of slow weight gain or death in the newborn rats. In a similar study, very high doses of ketotifen given by mouth to pregnant rabbits delayed the hardening of the sternum bone.
It is important to note that animals do not always respond to medicines 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 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, since very little of the medication actually reaches the bloodstream.
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