Old-fashioned asthma inhalers that contain environment-harming chemicals will no longer be sold at year's end — and the government is urging patients not to wait until the last minute to switch to newer alternatives.
Patients use inhalers to dispense airway-relaxing albuterol during asthma attacks.
Chemicals called chlorofluorocarbons, or CFCs, once were widely used to propel the drug into the lungs. But CFC-containing consumer products are being phased out because CFCs damage the Earth's protective ozone layer. As of Dec. 31, asthma inhalers with CFCs can no longer be made or sold in the U.S. Inhalers instead will be powered by ozone-friendly HFAs, or hydrofluoroalkanes.
The ozone layer shields the planet from harmful ultraviolet radiation.
HFA, which stands for hydrofluoroalkane, is an alternative propellant that is more earth-friendly. The same medicines are in the HFA inhalers as the CFCs, and they are proven to be just as effective. Only the propellant that is different.
The HFA inhalers are likely to be more expensive, at least for a few years, until generic versions become available. Many drug companies are providing assistance with HFA inhalers for people who need it, however, offering discount coupons and free trials.
Common asthma inhaler powered by a new propellant is safe and effective but could come at nearly triple the cost to consumers until a generic version hits the market, according to a review in the New England Journal of Medicine. Conducted by two university professors and a director for the Food and Drug Administration, the review examines the consequences of switching to hydrofluoroalkane, which is replacing chlorofluorocarbon, or CFC, as a key ingredient in albuterol inhalers designed to relieve asthma. The FDA has ruled that U.S. sales of CFC albuterol inhalers be prohibited after 2008.
Patients have been warned of the change for several years, but the Food and Drug Administration issued an advisory Friday saying anyone still using CFC inhalers should ask their doctor about switching now.
The FDA warns that patients will face a learning curve: HFA inhalers may taste and feel different. The spray may feel softer. Each must be primed and cleaned in a specific way to prevent clogs. And they tend to cost more.
CFC-free albuterol inhaler options include GlaxoSmithKline's Ventolin HFA, Schering Plough's Proventil HFA and Teva Specialty Pharmaceuticals' ProAir HFA. Sepracor's Xopenex HFA is also CFC-free, but it contains levalbuterol, a similar medication.
The FDA said Armstrong Pharmaceuticals is the sole remaining maker of CFC inhalers and is expected to stop production even before the deadline. A spokesman for Armstrong's parent company wouldn't say when production would stop, but sales of remaining inventory will continue until Dec. 31.
There are a number of reasons why now is a good time to make this transition:
* CFC-based inhalers are harmful to the environment.
* CFC quick-relief albuterol inhalers will not be available after December 31, 2008.
* HFA quick-relief albuterol inhalers are currently available and are the same medicine as the CFC-based version.
* During this transition, manufacturers will gradually reduce their supply of CFC-based quick-relief asthma inhalers and increase supplies of HFA-based quick-relief inhalers.
* Currently, HFA quick-relief albuterol inhaler manufacturers have programs for patients who need financial assistance to make the transition successfully.
* Making the transition to an HFA-based quick-relief albuterol inhaler is a good opportunity to review your patient's overall asthma management plan with them.
First, you should know that the medication in your inhaler is not changing. What's changing is a chemical called chlorofluorocarbon (or CFC) that delivers the medication into your lungs. The problem is, CFCs are safe for you but hurt the environment. They damage the ozone layer that protects the earth from the sun's rays.
So as part of a global agreement, the United States will stop using CFCs. CFCs have already been removed from items like hair spray and deodorant. Instead, these items use hydrofluoroalkane—HFA, an earth-friendly alternative to CFCs. Now, HFA is being used in rescue inhalers too.
Moreover, the new and old inhalers differ in feel, force and taste, and how they are primed and cleaned. Advocates for people with asthma say doctors and patients have not been educated about the changes.
“What the government failed to do is to mandate anyone to tell patients and physicians this transition was happening,” said Nancy Sander, president of the asthma group. “There is no education, no monitoring of patients, no financial assistance to patients who have to pay higher prices for the new drugs.”
Patients and physicians needing further information on making the transition to an HFA quick-relief inhaler should contact the Asthma and Allergy Foundation of America (AAFA) at 1-800-7-ASTHMA.
References:
http://www.ap.google.com
http://www.aafa.org
http://www.fda.gov
http://www.aaaai.org
http://www.ufl.edu/
http://www.proventilhfa.com
http://www.nytimes.com
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