Azopt and Pregnancy
When high doses of Azopt (brinzolamide) were given to pregnant animals, it increased the risk of birth defects and other problems. Because of this, the eye medication has a pregnancy Category C rating, meaning it may not be safe to use in pregnant women. However, a healthcare provider may prescribe Azopt if the benefits outweigh the risks.
Can Pregnant Women Use Azopt?Azopt® (brinzolamide) is an eye medication approved for the treatment of high eye pressure and open-angle glaucoma. It is available only by prescription. It is not known if this medication is safe for use during pregnancy.
What Is Pregnancy Category C?The U.S. Food and Drug Administration (FDA) uses a pregnancy category system to classify the possible risks to a fetus when a specific medicine is taken during pregnancy. 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.
Azopt was given a pregnancy Category C rating because of problems seen in animal studies. This research showed that Azopt crosses the placenta in animals. Giving extremely high doses of Azopt by mouth to pregnant rats and rabbits increased the risk of extra skull bones, low fetal weight, and other problems. It should be noted that these doses were high enough to cause toxicity in the mother animals and were several times higher than would be used in humans.
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 pregnant woman outweigh any possible risks to the unborn child.