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Combivent and Pregnancy
In animal studies involving Combivent and pregnancy, the medication caused birth defects when it was given to pregnant rabbits and mice. However, animals don't always respond to drugs in the same way that humans do. Therefore, if you are taking Combivent and pregnancy occurs, your healthcare provider will consider the benefits and risks in your particular situation.
Combivent® (ipratropium and albuterol inhaler) is a prescription medication used to treat chronic obstructive pulmonary disease (COPD). The medication may not be safe for use in pregnant women. Albuterol (one of the components) has been shown to increase the risk of birth defects in pregnant animals.
In order to comply with the Montreal Protocol on Substances That Deplete the Ozone Layer, Combivent inhalers (in their original form) will not be available after July 2013 because they contain chlorofluorocarbons (CFCs), chemicals that deplete the ozone layer. A new formulation, Combivent Respimat, became available starting in October 2012. People using the old Combivent inhaler will need to get a new prescription in order to switch to the new Combivent Respimat inhaler.
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. Pregnancy Category C is given to medicines that have not been studied in pregnant humans but that do appear to cause harm to the fetus in animal studies. Also, medicines that have not been studied in pregnant women or animals are automatically given a pregnancy Category C rating.
Combivent was given a pregnancy Category C rating because of potential problems with albuterol in animal studies. When given to mice, albuterol caused birth defects, especially a cleft palate. In rabbits, albuterol caused brain and skull problems. In humans, it can increase the heart rate and blood sugar levels in the fetus. Ipratropium (the other component in Combivent) seems to be safer for use during pregnancy and has not been shown to cause any problems in animal studies.
It is important to note that animals do not always respond to medicines in the same way that humans do. Therefore, a pregnancy Category C medicine may be given to a pregnant woman if the healthcare provider believes that the benefits to the woman outweigh any possible risks to the unborn child.
Written by/reviewed by: Kristi Monson, PharmD; Arthur Schoenstadt, MD
Last reviewed by: Kristi Monson, PharmD