FDA seeks to drop CFC propellants from albuterol inhalers

www.packexpo.com ^ | 6/21/04 | FDA

[NotQuiteCricket]

FDA seeks to drop CFC propellants from albuterol inhalers

With two non-chlorofluorocarbon (non-CFC)-based albuterol metered dose inhalers (MDIs) now on the market for treatment of asthma, chronic obstructive pulmonary disease, US Food & Drug Administration, Washington, DC, proposes removing “essential-use” status of CFC propellant for this application (Docket No. 2003P-0029). If agency finalizes proposed rule, Use of Ozone-Depleting Substances; Removal of Essential-Use Designations, marketing of albuterol MDIs using CFC propellant would cease at end of transition period. Scientists associate CFCs with depletion of earth’s protective ozone layer. Most aerosols dropped use of CFC propellants more than 25 years ago. Under terms of Montreal Protocol, US ended production, importation of CFCs in 1996 for commercial applications like air conditioning refrigerant. Agency requests comments by 16 August 2004 on potential public health impact, availability of equivalent products, effective date of rule, length of transition period for phase-out. Submit comments including agency name, Docket No. 2003P-0029 to Federal eRulemaking Portal, www.regulations.gov, or agency website, www.fda.gov/dockets/ecomments, by email to fdadockets@oc.fda.gov (with Docket No. 2003P-0029 in subject line), by mail/courier Division of Dockets Management, 5630 Fishers Lane, Room 1061, Rockville, MD 20852.Follow-up: Wayne Mitchell, Center for Drug Evaluation and Research, +1 301-594-2041, Link: www.fda.gov.

[NotQuiteCricket]

I like packexpo.com - this is a nifty site. I think I recall some people on FR having asthma and not liking the new propellent. Just an update on CFC getting the boot all together.

[Bikers4Bush]

Time to stock up.

[NotQuiteCricket]

See - I thought there were some FReepers who would be interested. Any idea on who else would want to know about this?

[corkoman]

feon propellants are irreplaceable. Dry powder inhalers invariably increase the amount of drug deposited in the back of the throat. This is bad as the incidence of thrush from corticosteriod inhalers bumps up dramatically.

And I hafta question the basis of all this - that freons reduce ozone. Buncha hooey.

I bet I'll be able to buy freon propellant inhalers from Spain for another 10 years.

[Doctor Stochastic]

Use butane like hairspray. Non-smokers only, of course.

[Bikers4Bush]

Not really. I don't think anyone has an asthma ping list.

But I definately appreciate the info.

[Darnright]

This is pretty stupid, if you ask me. The CFC's, such as they are, are inhaled along with the medication.

How in heck do they "endanger" the environment??? Give me a flippin' break.

They better not screw with the effectiveness of these inhalers!

[B Knotts]

I wonder if this is just a cute way to remove the availability of generic albuterol. Everyone will have to get Ventolin or Proventil again.

[Sabertooth]

With two non-chlorofluorocarbon (non-CFC)-based albuterol metered dose inhalers (MDIs) now on the market for treatment of asthma, chronic obstructive pulmonary disease, US Food & Drug Administration, Washington, DC, proposes removing “essential-use” status of CFC propellant for this application (Docket No. 2003P-0029). If agency finalizes proposed rule, Use of Ozone-Depleting Substances; Removal of Essential-Use Designations, marketing of albuterol MDIs using CFC propellant would cease at end of transition period.

To whom is the FDA making this proposal? To itself?

Is this how this type of thing is supposed to be done?

Why is the Food and Drug Administration asking itself to change a regulation based on environmental concerns?

From a bureaucratice standpoint, this would make more sense to me (debatable ozone-CFC links aside) if the EPA was asking the FDA to change the "essential use" status. However, it appears that the FDA is generating the review on its own, based on a concern that falls outside that agency's purview.

[BARLF]

Thank you, I am interested. Mr. Flee uses Albuterol Inhaler for a quick fix. Combivent he uses every 4 hours round the clock. He uses Advair once a day and hates it.

More crap to deal with.

[Paleo Conservative]

The CFC's, such as they are, are inhaled along with the medication.

How in heck do they "endanger" the environment?

The CFS's are inert and not absorbed by the blood vessles in the lungs. The CFC's escape into the atmosphere when the person using the inhaler exhales.

[Scandi]

Thank you for posting this information on inhalers. The new inhalers that are being pushed on the market do not work like the older ones. It takes one half hour for the new Ventolin albuterol inhaler to work--I could be in tough shape by then. I had to stop using Serevent Diskus because most of the powder stayed in my mouth. That is not good and I did not need a medical doctor to understand the danger to my body. If it is in my mouth, it travels through the whole body. The reason we use inhalents is for the product to go right to the source. How does the gas used to propel the inhalers move into the environment if it all is inhaled into our bodies? I would like an answer to that question from the FDA. Thank you for revealing a health problem that will result in death or huge injuries to the lungs.

[TheBattman]

That was the first thing that came to my mind.

[NotQuiteCricket]

Ping.

You posted to this thread: http://www.freerepublic.com/focus/f-news/997840/posts?q=1&&page=101

Which brought a lot of people out who had asthma, or knew someone who did. I'm pinging you to an article about the FDA moving to remove CFC as a propellant.

[r9etb]

Interesting. Thanks for the info.

[Constitution Day]

Thanks for the ping.
I use an albuterol inhaler occasionally and this is the first I've heard of this.

[kenth]

Thanks for the ping. This is good to know. I use a CFC based Albuterol inhaler. What are the two inhalers that don't use them?

[NotQuiteCricket]

What are the two inhalers that don't use them[CFCs]?

I'm sorry, but I don't know.

[NotQuiteCricket]

What are the two inhalers that don't use them[CFCs]?

I'm sorry, but I don't know.

[kenth]

That's what I'm wondering.

The proposed change is open to comments from the public: http://www.accessdata.fda.gov/scripts/oc/dockets/comments/COMMENTSMain.CFM?EC_DOCUMENT_ID=412&SUBTYP=CONTINUE&CID=&AGENCY=FDA