Eliminating CFC-Albuterol
Ira Finegold MD
In the modern history of medicine therapeutic agents have been recalled, removed, or banned for many reasons. A very atypical withdrawal becomes final on December 31, 2008, which will be the last day of sale, transfer or even gifting of CFC-containing albuterol MDI’s. This is the first time, according to FDA’s Chowdhury [i], that an effective medication has been removed from the market in the USA for an environmental issue. Clearly the Montreal Protocol with its 191 signatory nations has made it clear that the benefits accrued by stopping chemicals that deplete the ozone layer outweigh the many problems, inconveniences, and costs of changing the propellants to non CFC products. The first HFA albuterol product was introduced in 1996, and since then two additional racemic albuterol MDI’s using HFA as a propellant have been brought to market. A separate product, L-albuterol, was also introduced two years ago. In the past three years there have been at least 3 albuterol HFA products available for large populations to use. The original requirements for post marketing surveillance and adequate supplies have been met, and so the transition has been progressing. A recent EPA estimate indicates that 60% of the patients who use albuterol MDI’s have already made the transition to an HFA product.
However, the products available are not identical, and each has specific differences, which should be noted and taken into consideration when they are prescribed. Since only branded products are available, prescriptions and patient instructions should be appropriate to each product.
Table 1 Summarizes some of these differences.
| Product | Contains Alcohol | Contains Oleic Acid | Active drug from mouthpeice | Sprays to prime | Prime after days without activity | Clean* | Lower limit of usage |
| Proventil HFA [ii] | yes | yes | 90 mcg | 4 | 14 days | Weekly | 4 years |
| Ventolin HFA [iii]** | no | no | 90 mcg | 4 | 14 days | Weekly | 4 years |
| Proair HFA[iv] | yes | no | 90 mcg | 3 | 14 days | Weekly | 12 years |
| Xopenex HFA[v] | yes | yes | 45 mcg*** | 4 | 3 days | Weekly | 4 years |
Cleaning recommendations for all products are similar and are approved by the FDA: remove the canister and wash the mouthpiece in running warm water, shake off excess water and allow the mouthpiece to air dry overnight. In case the inhaler is blocked and needs to washed immediately, wash as above and shake off excess water, then spray two puffs away from face. Then inhale the medication in the usual manner.
**Once this product is removed from the foil wrapper it should be discarded in 6 months even though there are sprays remaining in the counter.
*** Contains only levalbuterol which is half the other products.
[i] Chowdhury, B. Oral presentation at the Transition to Ozone-Safe Albuterol Metered-Dose Inhalers meeting April 11, 2008 at the Offices of United States Environmental Protection Agency, 1310 L Street , Washington, DC.
[ii] Proventil HFA package insert accessed from the internet on April 12, 2008 dated November 11, 2007.
[iii] Ventolin HFA package insert accessed from the internet on April 12, 2008 dated March 2008.
[iv] ProairHFA package insert accessed from the internet on April 12, 2008 dated February 2006
[v] Xopenex package insert accessed from internet on April 12, 2008 dated September 2005.