Eyes Home > Prolensa and Pregnancy

As a pregnancy Category C medication, Prolensa (bromfenac) may not be safe for use in women who are expecting. When this drug was given orally to pregnant animals, it increased the risk for miscarriages and caused problems with labor and delivery. However, a healthcare provider may prescribe this drug to a pregnant woman if the benefits outweigh the risks.

Can Pregnant Women Use Prolensa?

Prolensa™ (bromfenac ophthalmic solution) is a prescription medicine used to reduce pain and swelling after cataract surgery. Prolensa may not be safe for use in pregnant women, although the full risks are currently unknown.

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. Prolensa 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.
Prolensa has not been studied in pregnant women. In animal studies, the drug did not cause birth defects when given by mouth to pregnant rats and rabbits. It did, however, increase the risk for miscarriages when given in very high doses. The drug also caused problems with labor and delivery and decreased the growth of the offspring in the pregnant rats.
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.
Prolensa belongs to a group of medicines known as nonsteroidal anti-inflammatory drugs (NSAIDs). It is generally recommended that NSAID medications be avoided during the third trimester of pregnancy because they can cause complications during labor and delivery and may have negative effects on the heart of the fetus. 
It is important to note, however, that Prolensa is a prescription eye drop, and very little (if any) of the medicine is absorbed into the bloodstream after normal use. Therefore, the drug is not likely to be associated with the same risks as NSAIDs taken by mouth. However, until more information is available, the possibility that Prolensa may be harmful if used during pregnancy cannot be ruled out. The manufacturer of the medication recommends that it should not be used during late pregnancy.
Written by/reviewed by:
Last reviewed by: Kristi Monson, PharmD;
Last updated/reviewed:
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