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