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U.S. Department of Health and Human Services

Drugs

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Public Health Advisory: National Transition from Chlorofluorocarbon (CFC) Propelled Albuterol Inhalers to Hydrofluroalkane (HFA) Propelled Albuterol Inhalers

5/30/2008

FDA is alerting patients, caregivers, and healthcare professionals to important information about albuterol inhalers. As part of a multi-year phase out, chlorofluorocarbon (CFC) propelled albuterol inhalers will not be available after December 31, 2008. Healthcare professionals should transition patients to the hydrofluoralkane (HFA) propelled albuterol inhalers now.

Albuterol inhalers are used to treat bronchospasm (wheezing) in patients with obstructive airways disease, such as asthma and chronic obstructive pulmonary disease (COPD). The propellants (spray), CFC and HFA, push the albuterol out of the inhaler allowing patients to then inhale the medicine. Currently there are three approved HFA propelled albuterol inhalers: Proair HFA Inhalation Aerosol, Proventil HFA Inhalation Aerosol, and Ventolin HFA Inhalation Aerosol. In addition, an HFA propelled inhaler containing levalbuterol, a medicine similar to albuterol, is available as Xopenex HFA Inhalation Aerosol. Each of the above four HFA propelled inhalers is a safe and effective replacement for CFC propelled albuterol inhalers. The manufacturers of HFA inhalers have increased production so that there is adequate supply of these products available now.

HFA propelled albuterol inhalers may taste and feel different than the CFC propelled albuterol inhalers. Notably, the force of the spray of an HFA propelled inhaler may feel softer than that of a CFC propelled inhaler. It is important to both prime and clean the HFA propelled inhalers. In particular, cleaning helps prevent blockage in the inhaler device that will prevent the medicine from reaching the lungs. Each HFA propelled inhaler has different priming, cleaning, and drying instructions. Therefore, it is important to read and understand the instructions that come with each of the HFA propelled albuterol inhalers before using.

The national transition from CFC propelled to HFA propelled albuterol inhalers is due to an international environmental treaty called the Montreal Protocol on Substances that Deplete the Ozone Layer. Under this treaty, the United States has agreed to phase out production and importation of Ozone Depleting Substances (ODS) including CFCs. Several CFC propelled inhalers containing other medicines have already been phased out. Over the next several years, other CFC propelled inhalers will be phased out. You can find more information at Information on the Elimination of Chlorofluorocarbon-containing (CFC) Albuterol MDIs and Other Ozone-Depleting Drug Products.