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Zometa and Pregnancy

It is generally not recommended for pregnant women to take Zometa. In clinical studies on Zometa and pregnancy, the medicine caused birth defects, decreased survival of newborns, and increased the risk of miscarriages when it was given to pregnant animals. Because of these potential risks, healthcare providers will only prescribe Zometa to pregnant women if the benefits outweigh the possible risks to the unborn child.

Zometa and Pregnancy: An Overview

Zometa® (zoledronic acid) is a prescription medication used to prevent bone problems or treat high blood calcium caused by cancer. The manufacturer of Zometa warns that pregnant women should not take this medication. Studies in pregnant animals have suggested that Zometa may cause problems when used during pregnancy.

Zometa and Pregnancy Category D

The U.S. Food and Drug Administration (FDA) uses a pregnancy 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 that the drug presents. A pregnancy Category D medicine may still be given to a pregnant woman if the healthcare provider believes that the benefits to the woman outweigh the possible risks to the unborn child.
Even though Zometa has not been studied in pregnant women, it was still given a pregnancy Category D because of the many problems seen in animal studies. The following problems were seen when Zometa was given to pregnant animals:
  • Death of the pregnant animals during labor
  • Birth defects, including bone defects
  • Increased risk of miscarriages
  • Increased risk of stillbirth
  • Decreased survival of newborns
  • Difficult or prolonged labor.
In all but the rarest of circumstances, you should not take Zometa if you are pregnant or may become pregnant in the near future. If you are pregnant or thinking about becoming pregnant, let your healthcare provider know. He or she will consider both the benefits and risks of taking Zometa during pregnancy before making a recommendation for your particular situation.
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