Eyes Home > Restasis and Pregnancy

Based on the results of animal studies, Restasis (cyclosporine ophthalmic emulsion) is considered a pregnancy Category C medicine. This means that it may not be safe for use by women who are expecting. When extremely high doses of the drug's active ingredient were given to pregnant animals, it decreased survival rate, lowered fetal weight, and caused problems with bone development.

I'm Pregnant -- Can I Use Restasis?

Restasis® (cyclosporine ophthalmic emulsion) is a prescription medication used to treat chronic dry eyes. Because this medication comes in the form of an eye drop, the levels in the body are expected to be very low or nonexistent, even after repeated Restasis use.
Based on this information, as well as information from animal studies, this drug does not appear to be particularly dangerous during pregnancy. However, all of the possible risks to humans are largely unknown at this time.

What Is 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.
Restasis eye drops have not been studied in pregnant women or in pregnant animals. However, cyclosporine, the active ingredient in Restasis, has been studied in pregnant rats and rabbits.
When given orally to pregnant rats and rabbits, high doses of cyclosporine did not cause birth defects. However, extremely high doses (equivalent to 30,000 to 100,000 times the exposure expected with normal Restasis use) decreased the number of live fetuses, decreased fetal weight, and led to problems with bone development.
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.
Written by/reviewed by:
Last reviewed by: Kristi Monson, PharmD;
Last updated/reviewed:
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