• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Drugs

  • Print
  • Share
  • E-mail

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

Listen to this Podcast
On April 13, 2010 the Food and Drug Administration issued a drug safety communication titled: Questions and Answers: Phase-Out of C-F-C Metered-Dose Inhalers Containing flunisolide, triamcinolone, metaproterenol, pirbuterol, albuterol and ipratropium in combination, cromolyn, and nedocromil

I am Yolanda Fultz-Morris from F-D-A's Center for Drug Evaluation and Research. FDA staff developed some questions and answers to increase understanding about FDA actions taken and the need for this communication. Kara Daniel, pharmacist in the Division of Drug Information, will provide the responses.

 

Q1. What action is FDA taking today?

A. FDA is announcing publication of a final rule that will phase out seven different metered dose inhalers or M-D-Is that contain chlorofluorocarbons or 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.

 

Q2. What medicines are affected by the CFC inhaler phase-out?

A. The seven CFC inhalers being phased out are used to treat patients with asthma or chronic obstructive pulmonary disease or C-O-P-D 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 C-O-P-D. Patients should talk with their health care professionals to decide what medicine is right for them.

 

Q3. When will these CFC inhalers be gone?

A. The Tilade Inhaler (nedocromil) will not be sold 60 days after the federal register notice.

The Alupent Inhalation Aerosol (metaproterenol) will not be sold 60 days after the federal register notice.

The Azmacort Inhalation Aerosol (triamcinolone) will not be sold after December 31, 2010.

The Intal Inhaler (cromolyn will not be sold after December 31, 2010.

The Aerobid Inhaler System (flunisolide) will not be sold after June 30, 2011.

The Combivent Inhalation Aerosol (albuterol and ipratropium in combination) will not be sold after December 31, 2013.

The Maxair Autohaler (pirbuterol) will not be sold after December 31, 2013.

These dates give patients time to switch to another medicine to treat their asthma or C-O-P-D.

 

Q4. What is likely to be the impact of this action on patients?

A. 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.

 

Q5. Why are CFC inhalers being phased out?

A. 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.Several 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.

 

Q6. What should I do if I use one of these CFC inhalers?

A. 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.

 

Q7. What other medicines can I use for my asthma or COPD?

A. 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: Drug Treatments for Asthma and Chronic Obstructive Pulmonary Disease that Do Not Use Chlorofluorocarbons at f-d-a dot g-o-v slash D-r-u-g-s slash D-r-u-g-S-a-f-e-t-y- slash I – n-f-o-r-m-a-t-i-o-n-b-y-D-r-u-g-C-l-a-s-s slash u-c-m-0-8-2-3-7-0 dot h-t-m.

FDA will work with companies to ensure enough other medicines are available.

 

Q8. How will the other medicines be different from the CFC inhaler I am using?

A. There are inhalers that use the propellant hydrofluoroalkane, or H-F-A, 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 C-O-P-D 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.

 

Q9. What can I do if it is hard for me to pay for the medicine my doctor prescribes?

A. 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 Servicesor C-M-S to see if C-M-S can provide help in paying for the medicine.

 

Q10. Is it safe to buy the other choices to replace my inhaler over the Internet?

A. 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" at f-d-a dot g-o-v slash D-r-u-g-s slash R-e-s-o-u-r-c-e-s-F-o-r-Y-o-u slash u-c-m-0-8-0-5-8-8 dot h-t-m

 

Q11. How can I find out more about the final rule and the phase-out?

A. 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 the following FDA web pages:

Updated information about drugs with emerging safety concerns is available 24 hours a day at our website w-w-w dot FDA dot G-O-V/D-R-U-G-S.

 

Contact FDA

1-800-332-1088
1-800-FDA-0178 Fax
Report a Serious Problem

MedWatch Online

Regular Mail: Use postage-paid FDA Form 3500

Mail to: MedWatch 5600 Fishers Lane

Rockville, MD 20857