/* mobile /* end mobile MEDDESKTOP: Changes In Albuterol Delivery System, Albuterol Inhaler With HFA.

Monday, June 02, 2008

Changes In Albuterol Delivery System, Albuterol Inhaler With HFA.

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Albuterol is a quick-relief medication that's used to open up the airways so that it's easier to breathe. The medication is used by people with certain airway diseases, such as asthma and chronic obstructive pulmonary disease (COPD), a group of lung diseases that includes chronic bronchitis and emphysema.

One method of delivering albuterol is the metered dose inhaler, a hand-held device that delivers a specific amount of medication directly into the lungs. Traditionally, inhalers have contained chlorofluorocarbons (CFCs), a type of propellant that helps the albuterol reach the lungs. But inhalers with CFCs are being phased out because they are harmful to the environment.

Here are facts you should know about switching from your CFC-propelled albuterol inhaler to inhalers that contain propellants called hydrofluoroalkanes (HFAs).

CFCs deplete the ozone layer.

CFCs deplete ozone high up in the stratosphere--the part of the earth's atmosphere that protects us from the sun's harmful ultraviolet radiation. In the stratosphere, the ozone layer serves as a shield that absorbs ultraviolet radiation and keeps it from reaching the earth's surface. CFCs are among the substances that damage the ozone layer. This leads to higher levels of ultraviolet B radiation, which has negative effects, including increases in skin cancers and cataracts. Under an international agreement, the United States, along with almost all countries of the world, agreed to phase out CFCs and other ozone-depleting substances.

CFC-propelled albuterol inhalers will no longer be available after Dec. 31, 2008.

In accordance with an FDA Final Rule and under the authority of the Clean Air Act of the U.S. Environmental Protection Agency, no CFC-propelled albuterol inhalers can be produced, marketed, or sold in the United States after Dec. 31, 2008. Manufacturers have been increasing production of HFA-propelled albuterol inhalers so that sufficient supplies exist to replace the CFC-containing inhalers. If you haven't done so already, you should talk with your health care professional about switching to an HFA-propelled albuterol inhaler.

Albuterol inhalers containing HFAs deliver the same medicine, but there are some differences.

The HFA-propelled albuterol inhalers are still convenient and have been shown to be safe and effective in studies with patients. But you may find that the spray from an HFA inhaler tastes and feels different than the spray from the CFC-propelled albuterol inhalers. The spray from an HFA inhaler may feel less forceful, but this does not mean that the medication is not working.

Cleaning and priming your HFA inhaler are especially important.

Cleaning and priming helps prevent medication build-up and blockages, and ensures that the inhaler works properly. Priming an inhaler involves shaking it well and then releasing test sprays into the air. Be sure to hold the inhaler away from your face so that you don't get medication in your eyes. Each inhaler has specific instructions for cleaning and priming that you should follow. Refer to the patient information that accompanies the product.

Four alternative HFA-propelled inhalers are approved by FDA.

There are four products available that can be used to replace your CFC-propelled albuterol inhaler:

  • Proair HFA Inhalation Aerosol (Ivax Corp.)
  • Proventil HFA Inhalation Aerosol (Schering-Plough)
  • Ventolin HFA Inhalation Aerosol (GlaxoSmithKline)
  • Xopenex HFA Inhalation Aerosol (Sepracor)

While they have all been shown to be effective, there are some differences between the products. You may need to talk with your health care professional and try different inhalers to find the product that is right for you.

For More Information

Metered Dose Inhalers (MDIs)
www.fda.gov/cder/mdi/default.htm

FDA Safety Update: Asthma Medications
www.fda.gov/consumer/updates/asthmameds051308.html

FDA's Web Page on Eliminating Ozone-depleting Substances from Metered-Dose Inhalers
www.fda.gov/cder/mdi/albuterol.htm

1 comment:

George said...

Some folks are having some major problems with the new HFA inhalers.

The most compelling story is at consumer affairs:
http://www.consumeraffairs.com/news04/2009/02/asthma_hfa02.html

Read the thousands of complaints at this petition:
http://www.ipetitions.com/petition/saveCFCinhalers/signatures.html

More complaints:

https://www.savecfcinhalers.org/Guestbook.php

http://www.askapatient.com/viewrating.asp?drug=20503&name=PROVENTIL-HFA

http://www.opednews.com/populum/diarypage.php?did=11627

If you are unhappy with the new HFA inhalers, kindly sign the petition to save CFC inhalers.

http://www.savecfcinhalers.org

Also worth mentioning from the FDA website is the following:

http://www.fda.gov/cder/foi/nda/2001/20-983_Ventolin-HFA_medr_P1.pdf

These quotes taken directly from the new drug application for Ventolin HFA.

"In the multiple dose adolescent and adult studies, albuterol HFA showed a numerically smaller improvement in FEV1 than was seen with albuterol CFC"

"There was other evidence that the HFA formulation delivers a lower/less effective dose on a per acutation basis than the CFC product. In the single dose, dose ranging study in adults, and in the single dose methacholine challenge study in adults one and two acutations of albuterol CFC were statistically indistinguishable in terms of effect, whereas significant differences were seen between one and two acutations of albuterol HFA. Finally, the combined adolescent/adult studies showed that the HFA formulation had a longer median time to onset of effect(4.2-9.6 minutes versus 3.6-4.2 minutes), had a shorter duration of effect(1.55-3.30 hours versus 2.29 - 3.69 hours), and was associated with more albuterol 'back up' use than the CFC formulation."

"We note that in the two 12 week clinical trials in adolescents and adults, Ventolin HFA Inhalation Aerosol consistently showed a smaller effect size than Ventolin CFC Inhalation Aerosol"

"Because it is expected that many physicians will prescribe Ventolin HFA Inhalation Aerosol for patients who have previously used the CFC formulation, it would be appropriate to include some description of the relative effectiveness of these two formulations in the product label."

"Unfavorable changes in physical examinations were observed in the ears, nose, and throat category as follows: 8% placebo HFA; 13% albuterol HFA; and 5% albuterol CFC."

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