FDA Announces Phase Out of CFC-Based Asthma and COPD Inhalers
April 16, 2010 — In compliance with a rule about ozone-depleting substances, the US Food and Drug Administration (FDA) has announced that 7 available asthma and chronic obstructive pulmonary disease (COPD) metered-dose inhalers that use chlorofluorocarbons (CFCs) as propellants are being removed from the marketplace.
The phase out is to comply with the Montreal Protocol on Substances that Deplete the Ozone Layer. Alternative medications that contain hydrofluoroalkanes are available to substitute for the CFC-based products.
The affected products and their phase-out dates are as follows:
- nedocromil (Tilade Inhaler, King Pharmaceuticals), June 14, 2010
- metaproterenol (Alupent Inhalation Aerosol, Boehringer Ingelheim), June 14, 2010
- triamcinolone (Azmacort Inhalation Aerosol, Abbott Laboratories), December 31, 2010
- cromolyn (Intal Inhaler, King Pharmaceuticals), December 31, 2010
- flunisolide (Aerobid Inhaler System, Forest Laboratories), June 30, 2011
- albuterol and ipratropium in combination (Combivent Inhalation Aerosol, Boehringer Ingelheim Pharmaceuticals), December 31, 2013
- pirbuterol (Maxair Autohaler, Graceway Pharmaceuticals), December 31, 2013
According to the FDA press release, the United States has banned the general use of CFCs in consumer aerosols for decades and eliminated the production of CFCs in the United States as of January 1, 1996, except for certain limited uses, such as metered-dose inhalers.
"Like most countries, the US signed this agreement and committed to making it illegal to make or sell CFC-containing substances after a certain date," said Erica V. Jefferson, a spokesperson with the FDA Office of Public Affairs in a conversation with Medscape Medical News. "Most CFC inhalers have already been phased out as part of this agreement," she added.
According to Ms. Jefferson, there are no special monitoring programs, and there will be no penalties for prescribers. "However, [the] FDA has been working with manufacturers, healthcare professionals, and patient groups to notify them that these CFC-containing products will no longer be available for sale or distribution after the transition dates," she told Medscape Medical News.
Many companies that make CFC inhalers have already stopped manufacturing some of the products on the transition list. These include Tilade, Alupent, Azmacort, and Intal. The remaining 3 products (Aerobid, Maxair, and Combivent) being transitioned between 2011 and 2013 are still available, but the amount of inventory remaining is unknown, Ms. Jefferson explained.
"Physicians should work with their patients to determine which alternative product or products will work best for their patients in terms of managing their disease, and which will work for their patients' lifestyle," Ms. Jefferson said.
Bradley E. Chipps, MD, from the Capital Allergy & Respiratory Disease Center and a fellow of the American Academy of Allergy Asthma and Immunology, said that this phase out will not significantly change clinical practice for practicing pulmonary specialists. However, he added, patients are less likely to be adherent because of higher costs for CFC-free products. "Importantly, [hydrofluoroalkane] inhalers can become 'stuffed up,' whereas the CFC inhalers did not have this problem," he told Medscape Medical News.
More information is available on the FDA Web site: