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FDA Drug Safety Podcast: 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.

I am Yolanda Fultz-Morris from F-D-A's Center for Drug Evaluation and Research.

Primatene Mist is approved by the Food and Drug Administration 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 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.

Many manufacturers have changed their inhalers to replace CFCs with an environmentally friendly propellant called HFA. There is currently no HFA version of the Primatene Mist inhaler.


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.


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

     

FDA urges healthcare providers and patients to report any adverse events or side effects that may be associated with the use of over-the-counter Primatene Mist inhalers to FDA's MedWatch adverse event reporting program by phone at 1-800-F-D-A-ten-88 or by the Internet at W-W-W dot F-D-A dot GOV slash M-E-D-W-A-T-C-H.

Updated information about drugs with emerging safety concerns is available 24 hours a day at our Web site W-W-W dot F-D-A dot GOV slash D-R-U-G-S.

 

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