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FDA ANNOUNCEMENT ON PHASE-OUT OF INHALERS

FDA ANNOUNCEMENT ON PHASE-OUT OF INHALERS
Posted By: Viola Dunn-Thigpen on May 29, 2013


Phase-Out Almost Complete
Millions Use Inhalers for Asthma or COPD
The last two inhalers in the United States that contain ozone-damaging chloroflurocarbons (CFCs) will both be taken off the market by the end of this year. People with asthma and chronic obstructive pulmonary disease (COPD) who use these inhalers should talk to their health care providers about a prescription for an alternative.

While change can be unsettling, most people who use inhalers have already switched to those that are CFC-free, and in general, the transition has gone smoothly. The final two inhalers on the market using CFCs are Combivent Inhalation Aerosol and Maxair Autohaler.

Combivent Inhalation Aerosol will no longer be available after July 2013. It contains two medicines—ipratropium bromide and albuterol sulfate. A bronchodialator intended to open airways, it is approved for patients with COPD. An alternative inhaler—Combivent Respimat—contains the same two medicines but does not contain CFCs. It was approved by the FDA in 2011.

Maxair Autohaler will not be available after Dec. 31, 2013. This inhaler contains pirbuterol, which is also a bronchodilator and is used for the treatment of bronchial spasms in patients with asthma or COPD. Alternative inhalers are available that contain other bronchodilator medicines, such as albuterol or levalbuterol, but do not use CFCs as a propellant to move the medicine from the inhaler.

May is Asthma and Allergy Awareness Month5, and thus an appropriate time to make sure people using these two inhalers know that alternatives should be considered before the product they are using goes off the market. Sponsored by the Asthma and Allergy Foundation, this awareness month is also a good time for people who suffer from those conditions—or who are exposed to high-risk conditions like cigarette smoke that may trigger the diseases—to learn about prevention, treatment and resources.

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Phase-Out Almost Complete
CFCs damage the ozone, a thin, outer layer in the stratosphere that acts as Earth's shield against the sun's radiation. The U.S. and most other countries signed an agreement in the 1980s called the Montreal Protocol to phase out the worldwide production and use of CFCs. In the U.S., CFCs have been removed from such products as hairsprays, deodorants and air conditioning.



CFCs have also been used in medical devices, including as propellants to move medicine out of inhalers so that patients can breathe in the medicine. For more than two decades, FDA has coordinated the phase-out of CFCs in inhalers, a process that included input from the public, advisory committees and stakeholders.

Most inhalers using CFCs have already been phased out. The most widely used—albuterol CFC inhalers—were phased out in 2008 and replaced with alternatives that use propellants called hydrofluoroalkanes (HFAs). The most recent phase-out was of over-the-counter epinephrine inhalers sold under the brand name Primatene Mist, which were phased out at the end of 2011.

On its website, FDA maintains a list of inhalers for asthma and COPD that do not use CFCs6, and adds the names of new non-CFC inhalers as they become available.

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Millions Use Inhalers for Asthma or COPD
Inhalers are critical products in helping those who suffer from asthma, allergies and COPD. In the U.S., more than 25 million people suffer from asthma, a disease that affects the airways in the lungs and can cause coughing, trouble breathing, wheezing and tightness or pain in the chest. Attacks can be mild, moderate, severe and even life-threatening.

Additionally, 15 million people in the U.S .have been diagnosed with COPD, a serious lung disease that usually causes breathing to get worse over time. It can limit airflow, and may include chronic bronchitis, emphysema or both.

While all FDA-approved inhalers currently on the market have been shown to be effective, there are some differences between the products. For example, products propelled by HFA may taste and feel different than the spray from CFC-propelled inhalers. Although some consumers note that the spray from an HFA inhaler feels less forceful, this does not mean that the medicine is not working. Other alternative medications may use no propellant at all. Your doctor or healthcare provider can help find the product right for you.

This article appears on FDA's Consumer Updates page7, which features the latest on all FDA-regulated products.

May 28, 2013

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-For More Information

CFC-Free Medication for an Ailing Ozone Layer8
May is Asthma Awareness Month9
--Related Consumer Updates

Primatene Mist With Chlorofluorocarbons No Longer Available After Dec. 31, 201110
Children and Asthma: The Goal Is Control11
-
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