Reclast and Pregnancy

Although human studies on Reclast and pregnancy have not been conducted, studies on pregnant animals show that Reclast can cause an increased risk of miscarriages and stillbirth, among other things. As a result, it was given a pregnancy Category D rating. However, if you are taking Reclast and pregnancy occurs, your healthcare provider may have you continue taking it if the benefits outweigh the risks.

Reclast for Paget's Disease

Using Reclast During Pregnancy: An Overview

Reclast™ (zoledronic acid) is a prescription medication used for Paget's disease of the bone and osteoporosis. The manufacturer of the drug warns that pregnant women should not take this medication. Studies in animals have suggested that Reclast may cause problems when used during pregnancy.

Reclast and Pregnancy Category D

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 D is a classification given to medicines that have been shown to present a risk to the fetus in studies of pregnant women but may still offer benefits that outweigh the risks the drug presents. A pregnancy Category D medicine may still be given to a pregnant woman if her healthcare provider believes that the benefits to the woman outweigh the risks to the unborn child.

Even though Reclast has not been studied in pregnant women, it was still given a pregnancy Category D rating, due to the many problems seen in animal studies. The following problems were seen when the drug was given to pregnant animals:

Increased risk of miscarriages
Increased risk of stillbirth
Decreased survival of newborns
Difficult or prolonged labor
Death of the pregnant animals during labor
Birth defects, including bone defects.

(Reclast and Pregnancy Continued: Page 2)