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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.

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Advice to Consumers Who Use Primatene Mist

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Help With Payment

Replacement medicines for Primatene Mist may cost more. If it is hard for you to pay for a new medicine:

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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.

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Contact FDA for More Information

Division of Drug Information (CDER)
Office of Communications
888-463-6332 or 301-796-3400
druginfo@fda.hhs.gov

Updated Sept. 22, 2011

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