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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 an international agreement to stop the use of substances that damage the environment.

Primatene Mist (epinephrine) 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 soon to switch to another asthma medicine.

Primatene Mist inhalers are being discontinued because they use chlorofluorocarbons (CFCs) as a propellant (spray) to move the medicine out of the inhaler so patients can breathe the medicine into their lungs.

CFCs harm the environment by decreasing 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 most other countries have signed an international agreement to phase out CFCs and other ozone-depleting substances.

“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 Primatene Mist and generic 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 an environmentally friendly propellant called hydrofluoroalkane (HFA). There is currently no HFA version of the Primatene Mist inhaler.

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Advice to Consumers Who Use Primatene Mist

  • See a health care professional soon to get another medicine. Primatene Mist may be harder to find on store shelves even before Dec. 31, 2011.
  • 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.

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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:

  • 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.
  • Contact the Partnership for Prescription Assistance by calling 1-888-477-2669 or visiting www.pparx.org.

This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.

Posted March 16, 2011

For more about food, medicine, cosmetic safety and other topics for your health, visit FDA.gov/ForConsumers.
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