Atelvia and Pregnancy
In clinical studies, giving Atelvia (risedronate delayed-release) to pregnant rats caused a variety of problems, including decreased fetal weight, bone problems, and cleft palate. It also increased the risk of death in the mother rats during labor and delivery. As a result, the FDA considers this a pregnancy Category C drug; in addition, it is only licensed for use in postmenopausal women.
Is It Safe for Pregnant Women to Take Atelvia?Atelvia™ (risedronate delayed-release) is a prescription medication used to treat osteoporosis. It may not be safe for use during pregnancy, although the full risks are not known at this time. Animal studies have suggested that Atelvia may cause problems when used during pregnancy.
Keep in mind that Atelvia is approved only for use in postmenopausal women, and is therefore not approved for use in women who may become or who are already pregnant.
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 that 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.
When given to pregnant rats, risedronate (the active ingredient in Atelvia) decreased the weight and survival of newborn rats. It also appeared to increase the risk of bone problems and cleft palate. In addition, the drug increased the risk of death of the pregnant rats during labor and delivery, probably related to low levels of calcium in the blood, since risedronate lowers blood calcium levels.
Atelvia is incorporated into bone and is slowly released from the bone over time; therefore, it is possible that it could cause problems in newly forming fetal bones. Also, because the drug is released slowly from the bones, stopping use of Atelvia before pregnancy may not completely eliminate the risks, since the drug stays in the body for a long time.
However, 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.