In previous animal studies involving Maxair and pregnancy, the medication increased the risk of miscarriages when given to pregnant rabbits. However, it is important to keep in mind that animals don't always respond to drugs the same as that humans do. Maxair may be prescribed to a pregnant woman if her healthcare provider believes that the benefits outweigh any possible risks to the unborn child. If you are taking Maxair and pregnancy occurs, let your healthcare provider know.
Is Maxair Safe During Pregnancy?
Maxair® (pirbuterol acetate) may not be safe for women who are pregnant. In animal studies involving Maxair and pregnancy, the drug caused miscarriages.
Maxair inhalers will not be made, dispensed, or sold in the United States in their current form after December 31, 2013. Maxair contains chlorofluorocarbons (CFCs), chemicals that deplete the ozone layer. The U.S. Food and Drug Administration (FDA) has set this final date for the medication in order to comply with the Montreal Protocol on Substances That Deplete the Ozone Layer. The manufacturer of Maxair is working on a reformulated, CFC-free version, although it is not yet clear when that product will be available to consumers.
Maxair and Pregnancy Category C
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 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.
Maxair was given a pregnancy Category C rating because of potential problems in animal studies. When given to pregnant rabbits, Maxair did not cause birth defects. However, it did increase the risks of miscarriages.
It is important to note that animals do not always respond to medicines 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 Maxair are usually essential for people with asthma, healthcare providers typically recommend that pregnant women continue to take medications like Maxair.
Food and Drug Administration, Center for Drug Evaluation and Research. Asthma and COPD inhalers that contain ozone-depleting CFCs to be phased out; alternative treatments available (4/13/2010). FDA Web site. Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm208302.htm. Accessed April 16, 2010.
Graceway Pharmaceuticals. Statement on the continued availability of Maxair Autohaler (pirbuterol acetate inhalation aerosol). Maxair Web site. Available at: http://www.maxair.com/MAXStillAvailable.pdf. Accessed April 16, 2010.
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