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Rescula and Pregnancy

Based on the results of animal studies, Rescula (unoprostone ophthalmic solution) is considered a pregnancy Category C medicine. This means that this drug may not be safe for women to use during pregnancy. When given to pregnant animals, the medication increased the risk for miscarriage, premature birth, delayed development, and other problems.

Can Pregnant Women Use Rescula?

Rescula® (unoprostone ophthalmic solution) may not be safe for use during pregnancy. This is based on animal studies that looked at the effects of the drug 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 taken during pregnancy. Rescula is classified as a pregnancy Category C medicine.
 
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.
 
When given as an injection under the skin (a subcutaneous, or SC, injection) to pregnant rats and rabbits, Rescula did not appear to cause birth defects, but did increase the risk for miscarriage. The drug also caused problems when given to rats in late pregnancy and while breastfeeding. These problems included premature birth, low birth weight, delayed growth and development, and decreased survival in the baby rats around the time of birth.
 
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.
 
As mentioned, when studied in animals, Rescula was given as an injection under the skin. With normal use, Rescula is an eye drop, which is used in the eye. Rescula has not been studied in pregnant women, and it is unknown if the problems observed in pregnant animals would also occur in humans.
 
Pregnancy and Pain

Rescula Medication Information

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