Binosto and Pregnancy
It is unknown if it is safe for women to use Binosto (alendronate effervescent tablet) during pregnancy. Research has not been done to determine the possible risks of using this medicine in pregnant women. However, the drug did cause problems, such as miscarriages and fetal death, when given to pregnant rats. Binosto should only be used during pregnancy if the benefits outweigh the potential risks.
Can Pregnant Women Take Binosto?
Binosto™ (alendronate effervescent tablet) is a prescription bisphosphonate medication used to treat osteoporosis. The medication may not be safe for pregnant women, although the full risks are not entirely 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 taken during pregnancy. Binosto is classified as a pregnancy Category C medicine.
Pregnancy Category C is given to medicines that have not been studied in pregnant women 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.
In animal studies, Binosto increased the risk of miscarriages and low fetal weights when given to pregnant rats, even at doses that were less than the usual recommended human dose. It also decreased calcium levels in the pregnant rats, which led to problems during delivery that included delays in delivery and fetal death. When given to the pregnant rats in high doses, the drug caused bone problems in the developing fetuses.
Binosto has not been adequately studied in pregnant women. Bisphosphonate medications are known to incorporate into bone, where they are gradually released over many years. Therefore, previous bisphosphonate use could theoretically pose a risk during pregnancy, even if a woman is no longer taking the medication when she becomes pregnant.
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 her healthcare provider believes that the benefits to the woman outweigh any possible risks to the unborn child.