Bepreve and Pregnancy
While animal studies showed that fetuses may be negatively affected by Bepreve, pregnant human women can probably use the drug without problems. The animal studies used extremely high doses -- the dosage typically prescribed is much lower. However, because Bepreve (bepotastine besilate) is a pregnancy Category C medication, the matter should still be discussed with your healthcare provider.
Is Bepreve Safe During Pregnancy?Bepreve™ (bepotastine besilate) is a prescription antihistamine medication approved to treat eye allergy symptoms. Animal studies have shown that absurdly high doses of the active ingredient in Bepreve might increase the risk of certain problems, although the low dosage used in humans is unlikely to cause such problems.
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 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.
In addition, medicines that have not been studied in any pregnant women or animals are automatically given a pregnancy Category C rating.
This product was given a pregnancy Category C rating because of problems seen in animal studies. When exceptionally high doses of bepotastine (the active ingredient in Bepreve) were given to pregnant animals by mouth, the drug increased the risk of skeletal abnormalities, stillbirth, and decreased growth and development of the offspring. There was also some evidence that very high doses increased the risk of infertility.
It is important to understand that these animal studies used extremely high doses, often greater than 15,000 times the equivalent recommended Bepreve dosage.
In addition, 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.