You Can Huff and You Can Puff…but Not On These After December 31, 2013!

Not that it is a big surprise to current users (at least we hope not), but the FDA announced on October 23, 2013 that they were completing the phase-out of all medical inhalation products containing chlorofluorocarbons (CFCs) by December 31, 2013.

The phase-out is to comply with an international treaty to protect the ozone layer by eliminating CFCsfrom these inhaled medicinal products.  FDA acknowledges that most CFC inhalers have already been removed from the market or converted to non-CFC propellants.  There are, however, two exceptions- Combivent Inhalation Aerosol and Maxair Autohaler still are being marketed-but these too will no longer be available after the end of December 2013.  FDA is advising patients and prescribers to begin the final process of switching to an alternate treatment to avoid an interruption in therapy.

The Notice goes on to say:

“CFCs were used as propellants to move the drug out of inhalers so that patients can inhale the medicine,” said Badrul Chowdhury, M.D., director of the Division of Pulmonary, Allergy and Rheumatology Products in the 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.”

Most inhalers that used CFCs have already been phased out by the FDA. The inhaler that was most widely used—albuterol CFC inhaler—was phased out in 2008 and replaced with inhalers that use propellants called hydrofluoroalkanes (HFAs). There are many safe and effective inhalers available to treat asthma and COPD symptoms. All of these inhalers require a prescription, which must come from a licensed health care professional (a physician, physician’s assistant or nurse practitioner).

“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.”

CFCs damage the ozone layer, a thin, outer layer in the stratosphere that acts as earth’s shield against the sun’s radiation. The United States and most other countries signed an agreement in 1987 called the Montreal Protocol on Substances that Deplete the Ozone Layer to phase out the worldwide production and use of CFCs. In the United States, CFCs have been removed from such products as hairsprays, deodorants and air conditioning.”

The full FDA Notice can be found here.  There are additional links information for patients and providers under the Notice.