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In animal studies involving Alupent and pregnancy, the medicine increased the risk of miscarriages and caused birth defects (especially brain and bone problems) when it was given at very high doses to pregnant rabbits. Therefore, the FDA has classified Alupent as a pregnancy Category C medication, meaning it may not be safe for women who are pregnant. However, healthcare providers typically recommend that pregnant women continue to use Alupent because "rescue" medications like Alupent are usually essential for people with asthma.
Is Alupent Safe During Pregnancy?
Alupent is no longer available in the United States. The manufacturer of this medication decided to stop making it in order to comply with regulations concerning chlorofluorocarbons (CFCs), chemicals that may deplete the ozone layer. Alupent was rarely used anymore; had it been more popular, the manufacturer probably would have chosen to reformulate the drug without CFCs, instead of just discontinuing it.
Alupent® (metaproterenol sulfate) may not be safe for women who are pregnant. In previous animal studies involving Alupent and pregnancy, the drug increased the risk of miscarriages and caused birth defects.
Alupent and Pregnancy Category CThe 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 C is given to medicines that have not been studied in pregnant humans, but 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.
Alupent was given a pregnancy Category C rating because of potential problems in animal studies. When given to pregnant rabbits at very high doses, Alupent caused brain and bone problems, and also increased the risk of miscarriages.
However, it is important to note that animals do not always respond to medicines in the same way that humans do. A pregnancy Category C medicine may be given to a pregnant woman if the healthcare provider believes that the benefits to the pregnant woman outweigh any possible risks to the unborn child. Because "rescue" medications like Alupent are usually essential for people with asthma, healthcare providers typically recommend that pregnant women continue to take medications like Alupent.