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Phase-Out of CFC Metered-Dose Inhalers Containing flunisolide, triamcinolone, metaproterenol, pirbuterol, albuterol and ipratropium in combination, cromolyn, and nedocromil - Questions and Answers

 [4/13/2010]

1. What action is FDA taking today? 

2. What medicines are affected by the CFC inhaler phase-out?   

3. When will these CFC inhalers be gone? 

4. What is likely to be the impact of this action on patients?

5. Why are CFC inhalers being phased out? 

6. What should I do if I use one of these CFC inhalers?  

7. What other medicines can I use for my asthma or COPD? 

8. How will the other medicines be different from the CFC inhaler I am using?

9. What can I do if it is hard for me to pay for the medicine my doctor prescribes?

10. Is it safe to buy the other choices to replace my inhaler over the Internet?

11. How can I find out more about the final rule and the phase-out?

 

1. What action is FDA taking today? 

FDA is announcing publication of a final rule that will phase out seven different metered dose inhalers (MDIs) that contain chlorofluorocarbons (CFCs). These inhalers use CFCs as propellants to spray the medicine out of the inhaler so patients can breathe the medicine into their lungs. The rule sets dates for the phase-out of each CFC inhaler. After those dates, these CFC inhalers cannot be made, dispensed, or sold in the United States.   
 

2. What medicines are affected by the CFC inhaler phase-out?

The seven CFC inhalers being phased out are used to treat patients with asthma or chronic obstructive pulmonary disease (COPD) or both. They are: 

  • Tilade Inhaler (nedocromil)
  • Alupent Inhalation Aerosol (metaproterenol)
  • Azmacort Inhalation Aerosol (triamcinolone)
  • Intal Inhaler (cromolyn)
  • Aerobid Inhaler System (flunisolide)
  • Combivent Inhalation Aerosol (albuterol and ipratropium in combination)
  • Maxair Autohaler (pirbuterol)

Many other safe and effective medicines are available for patients with asthma or COPD (See #6 and 7 below). Patients should talk with their health care professionals to decide what medicine is right for them.  
 

3. When will these CFC inhalers be gone?

The chart below shows the last day these CFC inhalers can be sold. These dates give patients time to switch to another medicine to treat their asthma or COPD.

 

Inhaler Medicine Last Date to be manufactured, sold or dispensed in U.S. Manufacturer
Tilade Inhaler (nedocromil) June 14, 2010 King Pharmaceuticals
Alupent Inhalation Aerosol (metaproterenol) June 14, 2010 Boehringer Ingelheim Pharmaceuticals
Azmacort Inhalation Aerosol (triamcinolone) December 31, 2010 Abbott Laboratories
Intal Inhaler (cromolyn) December 31, 2010 King Pharmaceuticals
Aerobid Inhaler System (flunisolide) June 30, 2011 Forest Laboratories
Combivent Inhalation Aerosol (albuterol and ipratropium in combination) December 31, 2013 Boehringer Ingelheim Pharmaceuticals
Maxair Autohaler (pirbuterol) December 31, 2013 Graceway Pharmaceuticals

 

 4. What is likely to be the impact of this action on patients?

Of the seven CFC inhalers listed in today’s announcement, four are no longer being made by companies.  Three CFC inhalers currently in use—Aerobid, Combivent and Maxair—will be phased out over the next one to three years.  These later phase-out dates give patients time to talk with their health care professional and switch to another medicine.  FDA will continue to reach out to companies, healthcare professionals and patients to ensure a smooth transition. 
 

5. Why are CFC inhalers being phased out?

CFCs are harmful to the environment because they decrease the protective ozone layer above the Earth.  The phase-out of CFC inhalers is due to an international agreement called the Montreal Protocol on Substances that Deplete the Ozone Layer that the United States signed along with most other countries. These countries promised to make it illegal after certain dates to make or sell substances, including CFCs that decrease the ozone layer. Most CFC inhalers have already been phased out as part of this agreement. 
 

6. What should I do if I use one of these CFC inhalers?  

If you use one of these CFC inhalers, talk with your health care professional and switch to a medicine that does not contain CFCs. You cannot be sure how long you will be able to buy your CFC inhaler, because manufacturers may stop making them before the last day they can be sold. For example, the companies that make metaproterenol (Alupent Inhalation Aerosol) and nedocromil (Tilade Inhaler) have already stopped making these medicines. If you have an inhaler after the last day the inhaler can be sold you may continue to use the inhaler.           
 

7. What other medicines can I use for my asthma or COPD?

There are many other inhalers available in the United States that do not contain CFCs. Talk to your health care professional to decide which choice is right for you. To see some of the FDA-approved treatments for asthma and COPD, visit the web page: Drug Treatments for Asthma and Chronic Obstructive Pulmonary Disease that Do Not Use Chlorofluorocarbons. FDA will work with companies to ensure enough other medicines are available. 
 

8. How will the other medicines be different from the CFC inhaler I am using?

There are inhalers that use the propellant hydrofluoroalkane, or HFA, instead of CFCs. There are also dry powder inhalers that don’t use a propellant at all, and liquids that are used with a nebulizer machine. These medicines to treat your asthma or COPD may look, feel, or taste different, and may be used differently than your CFC inhaler. When switching to a new medicine, ask your health care professional to show you how to use the new medicine correctly.  
 

9. What can I do if it is hard for me to pay for the medicine my doctor prescribes?

Talk to a health care professional about programs that can help get the medicine you need.

Check with the company that makes the medicine to see if it has a patient-assistance program that provides the medicine at no cost, or at a lower cost.

Check with the Centers for Medicare & Medicaid Services (CMS) to see if CMS can provide help in paying for the medicine. 
 

10. Is it safe to buy the other choices to replace my inhaler over the Internet?

When it comes to buying medicine online, it is important to be careful. Some websites sell medicine that may not be safe to use and could put your health at risk. For more information, please see our guide: "Buying Prescription Medicines Online: A Consumer Safety Guide. Buying your medicine online can be easy. Just make sure you do it safely." 
 

11. How can I find out more about the final rule and the phase-out?

More information about the final rule and phase-out of these seven inhalers, and other CFC inhalers that already have been phased out, can be found on these FDA webpages: