Chlorofluorocarbon Inhalers Fully Phased Out This Year
FDA announced the phase-out will be completed by Dec. 31.
The U.S. Food and Drug Administration announced it will complete its phase-out of all inhaler medical products containing chlorofluorocarbons (CFCs) by Dec. 31, 2013. This complies with an international treaty to protect the ozone layer by phasing out the worldwide production of numerous substances, including CFCs, that contribute to ozone depletion.
Most products containing CFCs already have been phased out, but two prescription products still on the market -- Combivent Inhalation Aerosol and Maxair Autohaler, used by people with asthma or chronic obstructive pulmonary disease -- will no longer be available after 2013.
Boehringer Ingelheim Pharmaceuticals, Inc. developed the COMBIVENT® RESPIMAT® Inhalation Spray as a replacement for the COMBIVENT Inhalation Aerosol as the aerosol's phase-out neared. COMBIVENT RESPIMAT Inhalation Spray is approved by FDA for the treatment of patients with COPD on a regular aerosol bronchodilator who continue to have evidence of bronchospasm and who require a second bronchodilator.
"CFCs were used as propellants to move the drug out of inhalers so that patients can inhale the medicine," said Dr. Badrul Chowdhury, M.D., director of the Division of Pulmonary, Allergy and Rheumatology Products in FDA's Center for Drug Evaluation and Research. "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 most widely used inhaler, albuterol CFC inhaler, was phased out in 2008 and replaced with inhalers that use propellants called hydrofluoroalkanes (HFAs).
"The EPA and FDA's partnership has facilitated a safe, gradual transition to CFC-free inhalers in the United States," said Drusilla Hufford, director of EPA's Stratospheric Protection Division of the Office of Air and Radiation. "This action is an important contribution to the global effort to repair the earth's protective ozone layer and save millions of lives through the prevention of skin cancer."