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Primatene Mist to be Banned in 2012

FDA Offers Advice to Users


Primatene Mist with Chlorofluorocarbons Being Banned by FDA

Primatene Mist with Chlorofluorocarbons Being Banned by FDA

Food and Drug Administration
Updated March 17, 2011
Primatene Mist, the only over-the-counter asthma inhaler currently sold in the United States, will be banned from sale starting in 2012 due to the product's use environment-damaging chlorofluorocarbons.

According to the U.S. Food and Drug Administration (FDA), Primatene Mist will be banned from store shelves beginning on December 31, 2011 as part of an international agreement to stop the use of substances that damage the environment.

Chlorofluorocarbons (CFCs), used in Primatene Mist as a propellant that helps users breathe the medicine into their lungs; have been shown to deplete the earth's radiation protective ozone layer. The United States and most other countries have signed an international agreement to phase out CFCs and other ozone-depleting substances.

Are There Alternatives?

According to the FDA, while many makers of prescription-only asthma medications have replaced the CFCs in their inhalers with an environmentally friendly propellant called hydrofluoroalkane (HFA), there is currently no HFA version of the Primatene Mist inhaler.

In press release, Dr. Badrul Chowdhury, director of FDA's Division of Pulmonary, Allergy, and Rheumatology Products pointed out that users of Primatene Mist should confirm with a doctor that they really have asthma, "not just pick another over-the-counter medicine."

"If you have breathing problems but have not been diagnosed by a health care professional, it's important to see one," said Dr. Chowdhury. " Not all breathing problems are asthma, so you need to get an accurate diagnosis and the proper medicine."

FDA Advice for Primatene Users

Fully aware of the product's popularity, the FDA offered the following advice to users of Primatene Mist:
  • Since Primatene Mist may become harder to find even before Dec. 31, 2011, see your doctor soon to get another medicine.
  • Be sure your doctor shows you how to use your new inhaler or medication correctly.
  • 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 for Primatene Mist Replacement

The FDA is also aware that prescription replacements for Primatene Mist will probably be more expensive and offers the following advice to those who might find it hard to pay for a new asthma medication:
  • 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.

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