Primatene Mist With Chlorofluorocarbons No Longer Available After Dec. 31, 2011

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The only over-the-counter asthma inhaler sold in the United States will no longer be available next year 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.

Primatene Mist is approved by the Food and Drug Administration (FDA) for the temporary relief of occasional symptoms of mild asthma. FDA urges those who use Primatene Mist to see a health care professional now to switch to another asthma medicine.

“There are many other safe and effective medications to treat the symptoms of asthma,” says Badrul Chowdhury, M.D., Ph.D., director of FDA’s Division of Pulmonary, Allergy, and Rheumatology Products. But you need to find out if you really have asthma—not just pick another over-the-counter medicine, adds Chowdhury. “If you have breathing problems but have not been diagnosed by a health care 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.”

FDA first began public discussion about the use of CFCs for epinephrine inhalers in January 2006. FDA finalized the phase-out date for using CFCs in these inhalers and 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 website8 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 Primatene Mist by Dec. 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.

Help With Payment
Replacement medicines for Primatene Mist may cost more. If it is hard for you to pay for a new medicine:
Talk to your health care professional about programs that help patients get medicines they need.
Contact the company that makes the drug that your health care professional prescribes. The company may have a patient-assistance program that makes medicines available to patients at low or no cost.
Visit free local clinics and public hospitals for additional assistance with your medications.
Why No More Primatene Mist?
Primatene Mist inhalers use CFCs, which decrease the earth's ozone layer. 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 United States and many other countries have signed an international agreement to phase out CFCs and other ozone-depleting substances.

This article appears on FDA's Consumer Updates page9, which features the latest on all FDA-regulated products.
Updated Sept. 22, 2011