The FDA announced that the last 2 asthma inhalers containing chlorofluorocarbon propellants will be phased out by the end of 2013 to comply with a treaty designed to protect the ozone layer.
The last asthma inhalers containing chlorofluorocarbon (CFC) propellants will be removed from the market by the end of the year to comply with an international treaty designed to protect the ozone layer from CFCs as well as other substances that harm it, the FDA announced recently.
A number of CFC inhalers have already been phased out, but 2 remain on the market: Combivent Inhalation Aerosol and Maxair Autohaler. As of December 31, 2013, they will no longer be available, and patients should consult with their health care provider to choose an alternative treatment. The Combivent inhaler will be available in a propellant-free form, but the Maxair Autohaler will be discontinued. A list of inhalers for asthma and COPD patients that do not include CFCs is available on the FDA’s website
“CFCs were used as propellants to move the drug out of inhalers so that patients can inhale the medicine,” said Badrul Chowdhury, MD, director of the Division of Pulmonary, Allergy and Rheumatology Products in the FDA’s Center for Drug Evaluation and Research, in a press release
. “For more than two decades, the FDA and EPA have collaborated to phase-out CFCs in inhalers—a process that included input from the public, advisory committees, manufacturers, and stakeholders.”
The treaty that requires the removal of CFCs from inhalers, the Montreal Protocol on Substances that Deplete the Ozone Layer, was signed in 1987. Since then, CFCs have been removed from a range of products, including hairsprays, deodorants, and air conditioners. The most widely used inhaler that contained the propellants, the albuterol CFC inhaler, was phased out in 2008 and replaced with inhalers that used hydrofluoroalkanes instead of CFCs.
At the end of 2011, Primatene Mist (epinephrine), which was the only OTC asthma inhaler at the time, was removed from the market because it used CFCs
. Approximately 3 million patients used Primatene Mist to treat their asthma symptoms, and many were upset that it was no longer available. In July 2012, its manufacturer, Amphastar Pharmaceuticals, launched a campaign to bring Primatene Mist back
. The effort, which was ultimately unsuccessful, was opposed by medical associations including the American Thoracic Society, which noted that epinephrine was no longer considered a safe medication for treating asthma.