Ozurdex and Pregnancy
As a pregnancy Category C medication, Ozurdex (dexamethasone intravitreal implant) may not be safe to use during pregnancy. In animal studies, the active ingredient was shown to increase the risk of birth defects, such as cleft palate. However, Ozurdex has not been studied in pregnant women, so the full risks are unknown. Talk to your healthcare provider if you are pregnant or thinking of becoming pregnant.
Can Pregnant Women Use Ozurdex?
Ozurdex® (dexamethasone intravitreal implant) is a prescription medication used to treat certain eye conditions, namely uveitis and macular edema. It comes as an implant that is injected into the eye. Based on the results of animal studies, this medication may not be safe for use in pregnant women, although the full risks are not known.
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. Pregnancy Category C is given to medicines that have not been studied in pregnant humans but did appear to cause harm to the fetus 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.
The active ingredient in Ozurdex (dexamethasone) has been shown to cause birth defects, as well as fetal deaths, when applied to the eyes of pregnant mice and rabbits. Specifically, it caused cleft palate in the mice offspring and multiple abnormalities of the head, ears, arms, legs, and other body parts in the rabbit offspring.
When given by injection to pregnant monkeys, dexamethasone caused skull defects in the offspring. Ozurdex has not been studied in pregnant women.
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 the healthcare provider believes that the benefits to the woman outweigh any possible risks to the unborn child.