Posted: Sep 23, 2011 12:44 PM by US Food & Drug Administration
Updated: Sep 23, 2011 12:44 PM
Primatene Mist, the only over-the-counter asthma inhaler sold in the U.S., will no longer be available after December 31, 2011, as part of a phase-out of epinephrine inhalers containing chlorofluorocarbons (CFCs).
Epinephrine CFC inhalers, marketed as Primatene Mist, are being phased out because they use CFCs as a propellant (spray) to move the medicine out of the inhaler so patients can breathe the medicine into their lungs.
The FDA says that the CFCs used in Primatene Mist inhalers decrease the earth's ozone layer; they state that this layer of the atmosphere protects us from some of the sun's harmful ultraviolet radiation, which can increase the risk of skin cancers and cataracts. The U.S. and many other countries signed an international agreement to phase out CFCs and other ozone-depleting substances.
Officials with the FDA urge people who use Primatene Mist to see a healthcare professional now to switch to another asthma medicine.
Dr. Badrul Chowdury of the FDA noted, "There are many other safe and effective medications to treat the symptoms of asthma. If you have breathing problems but have not been diagnosed by a healthcare professional, it's important to see one. Not all breathing problems are asthma, so you need to get an accurate diagnosis and the proper medicine."
The FDA first began public discussion about the use of CFCs for epinephrine inhalers in January 2006; the agency finalized the phase-out date for using CFCs in these inhalers and first notified the public in November 2008.
Many manufacturers have changed their inhalers to replace CFCs with a propellant called hydrofluoroalkane (HFA). For instance, albuterol HFA inhalers can be used in the same way you use epinephrine CFC inhalers. You can only buy albuterol HFA inhalers-or any inhaler after Dec. 31-with a prescription from your doctor. There is currently no over-the-counter or prescription epinephrine inhaler made without CFCs.
Advice to Consumers Who Use Primatene Mist
See a health care professional soon to get another medicine. A doctor, physician assistant, or nurse practitioner can all help you determine the best treatment option for you. Primatene Mist may be harder to find on store shelves even before Dec. 31, 2011. If you don't have a doctor or other health care professional, you can find one by
Asking a family member, friend, or co-worker what doctor they use and would recommend.
Visiting a federally funded health center, where patients pay to see a doctor based on their income and what they can afford. See this website or call 888-275-4772 to learn more.
Visiting a local clinic, community health center, or minute clinic (sometimes located in a pharmacy).
Ask your health care professional to show you how to use your new inhaler or other medicine to make sure you are using it correctly and getting the right dose.
Follow the directions for using and cleaning your new inhaler or other medicine to make sure you get relief of your asthma symptoms.
If you haven't used up your existing Primatene Mist by December 31, 2011, it's safe to continue using it as long as it hasn't expired. Check the expiration date, which can be found on the product and its packaging.