Glaucoma Home > Zioptan and Pregnancy

No research has been done on Zioptan (tafluprost) and pregnancy, so the full risks are unknown at this time. When the medication was given intravenously to pregnant animals, it increased the risk of miscarriages and birth defects. If you are using this drug and pregnancy occurs, your healthcare provider will weigh the benefits and potential risks before making a recommendation.

Can Pregnant Women Use Zioptan?

Zioptan® (tafluprost ophthalmic solution) is a prescription medication approved to treat open angle glaucoma and high eye pressure. It belongs to a group of medications known as prostaglandins. It is not clear if this medicine is safe for use during pregnancy, as the full risks are currently unknown. However, this product has been shown to cause serious problems when given to pregnant animals.
 

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 used during pregnancy. Zioptan is classified as a pregnancy Category C drug.
 
Pregnancy Category C is given to medicines that have not been adequately studied in pregnant humans but have caused fetal harm 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.
 
Zioptan was given a pregnancy Category C rating because of problems seen in animal studies. When Zioptan was given intravenously (by IV) to pregnant rabbits and rats, it caused miscarriages and birth defects. This medication has not been studied in pregnant women, and it is not known if similar problems would occur in humans.
 
However, 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 her healthcare provider believes that the benefits to the woman outweigh any possible risks to her unborn child.
 
Written by/reviewed by:
Last reviewed by: Kristi Monson, PharmD;
Last updated/reviewed:
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