Ocufen and Pregnancy
As a pregnancy Category C medication, Ocufen (flurbiprofen ophthalmic) may not be safe for women who are expecting. When the drug's active ingredient was given orally to pregnant rats, it resulted in prolonged pregnancies, smaller baby rats, and an increased risk for miscarriage. However, a healthcare provider may prescribe this drug to a pregnant woman if the benefits outweigh the risks.
Ocufen® (flurbiprofen ophthalmic) is a prescription medicine used to prevent changes in the eye that sometimes occur during eye surgery. This product may not be safe for use in pregnant women, although the full risks are currently unknown.
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. Ocufen 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.
In animal studies, flurbiprofen (the active ingredient in Ocufen) did not cause birth defects when given to pregnant mice, rats, or rabbits. However, pregnant rats given flurbiprofen by mouth had longer-than-normal pregnancies, smaller baby rats, and a higher risk for miscarriage. Doses that caused problems were at least 300 times the normal equivalent human topical (eye drop) dose. Ocufen has not been studied in pregnant women, and there are no reports describing the use of flurbiprofen in pregnant women.
Ocufen belongs to a group of medicines known as nonsteroidal anti-inflammatory drugs (NSAIDs). In observational studies, NSAID use during pregnancy has been associated with an increased risk for miscarriage. In addition, it is recommended that NSAIDs in general not be used during the third trimester, as they can cause complications during labor and delivery. More specifically, NSAIDs may inhibit labor, prolong pregnancy, and cause serious lung problems in the newborn.
It is important to note, however, that Ocufen is a prescription eye drop, and little of the medicine is likely to be absorbed into the bloodstream with normal use. Therefore, the drug may not be associated with the same risks as NSAIDs taken by mouth. However, until more information is available, the possibility that Ocufen may cause harm if used during pregnancy cannot be ruled out.