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An Allergist Reflects:  Primatine Mist and the FDA Ban of Asthma Inhalers Containing CFC

Published on Oct 24, 2011 with 3 comments

As a practicing allergist and asthma specialist, I have been privy to watch the repercussions of the FDA’s ruling banning of the use of chlorofluorocarbons (CFCs) in asthma inhalers during the years leading up to 2005 when the ban became law, and up until the present.

Over the past few years, this issue was all but forgotten until the recent flurry of new articles reminding the public that Primatine Mist, the only OTC, non-prescription asthma inhaler and the only remaining CFC containing asthma inhaler, will no longer be available on pharmacy shelves after December 31st.

Primatine is probably the last survivor of the ban which was mandated by the FDA as the result of environmental concerns articulated in the mid-1970’s that chlorofluorocarbons released into the atmosphere would deplete the earth’s ozone layer, increasing the risk of skin cancer, cataracts, and no doubt global warming.  CFCs, organic compounds that contain carbon atoms, chlorine atoms, and fluorine atoms, are relatively stable here on earth, but scientists and environmental advocates have expressed concerns that these inhaler releasing CFCs could deplete the ozone in the stratosphere, the zone about 15 to 40 km (10 to 25 miles) above the earth’s surface in which ozone is relatively highly concentrated.

From the outset, this asthma specialist could not understand the logic of removing CFCs from asthma inhalers. True, chlorofluorocarbons can have a deleterious effect on the environment, but, in my opinion, the ban should have been imposed on large sources of CFCs, such as refrigerants and air conditioning systems, insulation materials, solvents and cleaning agents, as well as aerosols which are sprayed into the environment.  As a prescriber of asthma inhalers for over 30 years, I never witnessed any of my patients going around discharging their inhalers into the atmosphere.  One could argue that the amount of CFCs released into the environment by asthma inhalers was miniscule and irrelevant.  Asthma patients sprayed their inhalers, chlorofluorocarbons and all, into their mouths and inhaled it into their lungs, not into the environment.

As a result of this ban, I have watched as pharmaceutical companies transition from using chlorofluorocarbons in the propellant of their asthma inhalers to using a more environmentally safe chemical called hydrofluoroalkane, or HFA.  But this transition has not been without great costs.  In order to transition, the FDA mandated to pharmaceutical companies that all asthma inhalers containing the new propellant containing hydrofluoroalkane, or HFA, must undergo rigorous clinical trials to prove its safety and efficacy.  I participated in those trials as a clinical investigator and can attest to the fact that pharmaceutical companies spent tens, perhaps hundreds of millions of dollars to transition from Proventil to Proventil HFA and from Ventolin to Ventolin HFA, just to name a few.  There is no doubt that these costs were passed on to the consumers, as the “environmentally safe” HFA containing inhalers cost at least three times that of the old CFC containing inhalers.

Something to think about.


Comments:

Thank you for echoing the sentiments expressed at http://bit.ly/p3eHNO several weeks ago.  But why doesn’t this sensible post have a byline?

By Henry Ehrlich on 2011 10 30

Thanks for this - I think something else the FDA hasn’t thought about is the fact that CFC inhalers just happen to be far more effective to some asthmatics and people with COPD or cystic fibrosis than HFA inhalers. Personally, Primatine Mist is the most effective inhaler I’ve ever used - far better than HFA albuteral inhalers.

By Caitlin on 2011 10 30

What can we do to change this?

By Frank Caposey on 2011 11 10

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