Inhaler Discontinued to Save the Planet

FDA finalized the phase-out of Primatene Mist

/ Author:  / Reviewed by: Joseph V. Madia, MD

As part of an international agreement to discontinue the use of chlorofluorocarbons that damage the environment, a leading over-the-counter asthma inhaler will not be available next year.

Primatene Mist® (epinephrine) is approved by the Food and Drug Administration (FDA) for the temporary relief of occasional symptoms of mild asthma. The FDA urges those who use Primatene Mist® to see a health care professional to switch to another asthma medicine. Primatene Mist® inhalers are being discontinued because they use chlorofluorocarbons (CFCs) as a propellant (spray) so asthmatics can breathe the medicine into their lungs.

"Before switching asthma medicines, see your doctor."

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, MD, PhD, 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.

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.

Over 22 million people in the United States have Asthma, with African American and Latino children at the greatest risk. Asthma is a chronic inflammatory disease of the lungs, which causes the airways to narrow, causing difficulty breathing. It is caused by a number of factors, but is generally agreed to be a primarily genetic and environmental disease. Symptoms of asthma are sudden difficulty in breathing, coughing, wheezing, and shortness of breath. Asthma is treated by lifestyle modification (avoiding allergens and triggers), as well as a multitude of medications for short term relief like albuterol(Ventolin®, ProAir®), ipratropium (Atrovent®), and epinephrine. Long-term care is treated with steroids (Clenil®, Pulmicort®, Symbicort®, Flovent®), leukotriene antagonists (ZYFLO®, Singulair®), and long acting beta-adrenoreceptor agonists (Serevent®, Foradil®). There is no precise diagnostic test for asthma, instead it is diagnosed based off of symptoms (airway blockage and hypersensitivity) and improvement of symptoms related to asthma medications.

Review Date: 
March 16, 2011