In previous studies involving Aerobid and pregnancy, the medication caused birth defects when it was given to pregnant rabbits and rats. However, it is important to keep in mind that animals don't always respond to drugs in the same way that humans do. Aerobid can still be prescribed to a pregnant woman if her healthcare provider believes that the benefits outweigh any possible risks to her unborn child.
Is Aerobid Safe During Pregnancy?
Aerobid® (flunisolide inhaler) may not be safe for women who are pregnant. In previous animal studies involving of Aerobid and pregnancy, the drug caused birth defects.
Aerobid inhalers will not be made, dispensed, or sold in the United States after June 30, 2011. Aerobid 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. People taking Aerobid should ask their healthcare providers about alternatives to Aerobid, keeping in mind that it is possible that Aerobid may become unavailable in pharmacies earlier than the final date.
Aerobid 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.
Aerobid was given a pregnancy Category C rating because of potential problems in animal studies. When given to pregnant rabbits and rats, Aerobid increased the risk of birth defects.
However, 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 her healthcare provider believes that its benefits to the pregnant woman outweigh any possible risks to her unborn child. Because medications like Aerobid can be essential for people with asthma, healthcare providers sometimes recommend that women continue to take Aerobid during pregnancy.
Written by/reviewed by: Kristi Monson, PharmD;Arthur Schoenstadt, MD
Last reviewed by: KristiMonson, PharmD;
List of references (click here):
Aerobid and Aerobid-M [package insert]. St. Louis, MO: Forest Laboratories, Inc.;2002 March.
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.
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