When given to pregnant animals, Omontys (peginesatide) appeared to increase the risk for miscarriages, low fetal weights, and various birth defects. Due to these risks, Omontys is classified as a pregnancy Category C medication. This means that this drug should only be given to a pregnant woman when the benefits to the mother outweigh the risks to the unborn child.
In February 2013, Omontys was pulled from the market (all of the product was recalled) to investigate reports of dangerous allergic reactions, including fatal anaphylactic reactions, which appear to be occurring more frequently than anticipated. This medication will not be available until further notice.
Can Pregnant Women Receive Omontys?
Omontys® (peginesatide) is a medication used to treat anemia caused by chronic kidney disease. In animal studies that looked at the effects of using Omontys during pregnancy, the drug increased the risk of certain problems.
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. Omontys is classified as a pregnancy Category C medication.
Pregnancy Category C is given to medicines that have not been adequately studied in pregnant humans but do appear to cause fetal harm 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.
Omontys was given this classification because of problems in animal studies. When given to pregnant animals, the drug increased the risk for miscarriages, low fetal weights, and a variety of birth defects.
However, pregnancy Category C medicines, including Omontys, 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.
Food and Drug Administration, Center for Drug Evaluation and Research. FDA alerts health care providers of recall of anemia drug Omontys (February 24, 2013). FDA Web site. Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm340899.htm. Accessed March 5, 2013.
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