Ketotifen and Pregnancy

The FDA considers ketotifen a pregnancy Category C medication, which means that it may be given to pregnant women if the benefits outweigh the risks. In animal studies, extremely large doses of the drug did cause problems. However, since animals do not always respond to medicines the same way as humans do, talk to your healthcare provider about your specific situation.

If I'm Pregnant, Can I Take Ketotifen?

Ketotifen (Alaway®, Zaditor®, Zyrtec® Eye Drops, Claritin® Eye) is a nonprescription eye drop used for the treatment of eye allergies. While it is not known for certain if this antihistamine medication is safe for use during pregnancy, the risks to the fetus appear to be quite minimal. Nonetheless, it is always a good idea to check with your healthcare provider before taking any medication during pregnancy, including ketotifen.

What Is 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 do appear to cause harm to the fetus in animal studies.
In addition, 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 to 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 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 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 generally expected, since very little ketotifen actually reaches the bloodstream.
Pregnancy and Pain
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