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Betaxolol and Pregnancy

Based on the results of animal studies, betaxolol may not be safe for pregnant women. When the drug was given in high doses to pregnant rats, it increased the risk of miscarriages and birth defects. If pregnancy occurs while you are taking betaxolol, your healthcare provider will weigh the benefits and potential risks before making a recommendation for your situation.

Is Using Betaxolol While Pregnant Safe?

Betaxolol hydrochloride (Betoptic®, Kerlone®) is a prescription beta blocker. It comes in the form of tablets or eye drops. Based on the results of animal studies, the medicine might not be safe for use during pregnancy, although the full risks are currently unknown.

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.
When given to rats, very high doses of betaxolol increased the risk of miscarriages and birth defects. However, it is important to understand that the dosages used were very high (600 times the maximum recommended human dose) and were toxic to the mother rats as well.
It is also important to note that animals do not always respond to medicines 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 outweigh any possible risks to the unborn child.
With beta blockers in general, there have been reports of slowed intrauterine growth, small placentas, and birth defects related to the use of beta blockers during pregnancy. There have also been reports of a very low heart rate, low blood sugars, and/or decreased breathing in some newborns when beta blockers were used during childbirth.
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