Actonel and Pregnancy
Based on the results of animal studies on Actonel and pregnancy, the drug was given a pregnancy Category C rating by the FDA. This means that it may not be safe to take during pregnancy. However, your healthcare provider may still prescribe it if the benefits outweigh the risks. If you are taking Actonel and pregnancy occurs, be sure to talk to your healthcare provider.
Actonel® (risedronate sodium) is a prescription medication used to prevent and treat osteoporosis and to treat Paget's disease of the bone. It may not be safe for use during pregnancy, although the full risks are not known at this time. Animal studies have suggested that the drug may cause problems when used during pregnancy.
Actonel and Pregnancy Category CThe 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. Also, 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, Actonel decreased the weight and survival of newborn rats. Actonel 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. Actonel is incorporated into bone and is slowly released from the bone over time; therefore, it is not clear if Actonel will cause problems in newly forming fetal bones.
However, it is 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 the healthcare provider believes that the benefits to the woman outweigh any possible risks to the unborn child.