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Betagan and Pregnancy

In animal studies, Betagan (levobunolol) increased the risk of miscarriages when it was given in high doses to pregnant rabbits. However, it is important to know that animals do not always respond to drugs in the same way that humans do. If pregnancy occurs while you are using Betagan, talk to your healthcare provider.

Is Betagan Safe During Pregnancy?

Betagan® (levobunolol hydrochloride) is a prescription medication used to treat glaucoma and high eye pressure. It is a beta blocker eye drop. It is not known if this medication is safe for use during pregnancy. Animal studies indicate that the medication could be harmful to a developing fetus.
 

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.
 
Betagan was given a pregnancy Category C rating because of problems seen in animal studies. Giving extremely large doses of Betagan increased the risk of miscarriages in rabbits. Similar problems did not occur in rats. Also, no evidence of an increased risk of birth defects (even with extremely large doses) was seen in rats.
 
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.
 
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Betagan Eyedrops

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