New EPA standards for propellants in inhalers

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Jerry Maras - 03 Jun 2007 19:43 GMT

This is the first time I've visited this group, though I've had asthma for
some 30 years. I take a steroid inhaler (Pulmacort) once or twice a day,
but still need my albuterol rescue inhaler at least twice a day.

I was getting the generic albuterol (with it's $10 co-pay) until about a
week ago because it's no longer available. It seems the EPA is more
concerned about what the miniscule amount of propellant is supposedly doing
to the ozone layer than they are concerned about my rights to medical
treatment.

Now I was forced to buy the non-generic Proventil (with it's $30 co-pay for
fewer doses), because they apparently offer the "envoronment friendly
propellent" and the generic equivalent doesn't. Let me tell you, the EPA
friendly propellent makes me nauseous, causes me to gag and choke and gives
me severe heartburn. Has anyone else experienced this? I wonder how much
of the EPA's mandate was intended because of the ozone layer, and how much
was to get a generic off of the market. It's my understanding that
Proventil will now have 3 years of exclusivity on albuterol before another
generic equivalent will be allowed.

I can't imagine that those little inhalers used in the miniscule dosages
that they are, actually do become any environmental threat whatsoever, and
this just smacks of government and big business bending us over again.

What say you?

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00doc - 03 Jun 2007 21:49 GMT

> This is the first time I've visited this group, though I've had asthma for
> some 30 years. I take a steroid inhaler (Pulmacort) once or twice a day,
> but still need my albuterol rescue inhaler at least twice a day.

In that case you should be using the Pulmicort at least twice daily and
maybe adding meds to that.

> I was getting the generic albuterol (with it's $10 co-pay) until about a
> week ago because it's no longer available. It seems the EPA is more
[quoted text clipped - 9 lines]
> how much of the EPA's mandate was intended because of the ozone layer, and
> how much was to get a generic off of the market.

Actually, the CFC's were outlawed except for some "essential uses" in 1978.
Hairspray did not make the cut while inhalers did. With the advent of HFA
propellants and dry powdered inhalers CFC's inhalers lost their "essential"
status.

You are not the only one who has had problems with the HFA inhalers. Many
people prefer the CFC ones for reasons that are not entirely clear.

http://www.fda.gov/cder/mdi/mdifaqs.htm

> It's my understanding that Proventil will now have 3 years of exclusivity
> on albuterol before another generic equivalent will be allowed.

There have always been two brands of albuterol - Proventil and Ventolin -
and they both have HFA inhalers out. There is a third one being marketted by
Ivax called Pro-air. It is a red inhaler (as opposed to the traditional
yellow for Proventil and Blue for Ventolin). Anecdotally, I have heard that
the Pro-air delivery device is more prone to clogging and requires people to
actually follow the instructions regarding cleaning to keep working. The
Pro-Air delivery device is not a generic according to FDA (or insurance
co-pay) standards but due to some tricky maneuvering they have convinced a
lot of pharmacists that they are.

The first one that will lose its patent will be Proventil HFA. It has been
out since 1996 so it should be running out around 2010.

One thing that is very concerning to me is that part of their consideration
was cost and access. The FDA was satisfied by promises from the drug
manifacturers that they would maintain programs to provided free and reduced
cost inhalers to poorer pts. I have never had quite that much faith in the
magnominitity of the pharmacuetical companies and would have prefered a more
contrete arrangement with more teeth.

> I can't imagine that those little inhalers used in the miniscule dosages
> that they are, actually do become any environmental threat whatsoever, and
> this just smacks of government and big business bending us over again.
>
> What say you?

I agree that it is unlikely that the CFC's in medical inhalers are unlikely
to be an environmental threat. On the other hand, the rationale for the
switch is not all the cryptic once it is understood. I'm honestly uncertain
about how much big business is driving this. The decision is based on an
international treaty (The Montreal Protocol). The only part the US FDA has
control over is whether to exclude the inhalers as "essential" based on
clearly outlined cricterion. I understand your concerns (and that you are
far from alone) but the counter argument is compelling as well. I think they
should have done more research into how variable the response is between
patients to the new inhalers.

As far as your asthma is concerned Advair discus, formoterol (Foradil) and
Combivent all come in dry powder inhalers or CFC inhalers (Combivent).
Albuterol has been studied as a dischaler (similar to Advair/ Serevent) but
I do not know about their plans to introduce it. None of this will help with
the cost issues as they are all branded drugs.

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00doc

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pavane - 03 Jun 2007 22:24 GMT

.............

> As far as your asthma is concerned Advair discus, formoterol (Foradil) and
> Combivent all come in dry powder inhalers or CFC inhalers (Combivent).
> Albuterol has been studied as a dischaler (similar to Advair/ Serevent)
> but I do not know about their plans to introduce it. None of this will
> help with the cost issues as they are all branded drugs.

.............

The Xoponex is also available with HFA inhalers, by the way.
And just as I have become very impressed with Xoponex for
the considerable reduction in jitters from its use as opposed
to albuterol, the VA has switched from Xoponex to Proventil
HFA. Go figure.

pavane

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miles - 04 Jun 2007 00:19 GMT

> I was getting the generic albuterol (with it's $10 co-pay) until about a
> week ago because it's no longer available. It seems the EPA is more
> concerned about what the miniscule amount of propellant is supposedly doing
> to the ozone layer than they are concerned about my rights to medical
> treatment.

ProAir makes albuterol HFA and its a little cheaper than Proventil or
Ventolin.

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Mike Dobony - 04 Jun 2007 03:09 GMT

> This is the first time I've visited this group, though I've had asthma for
> some 30 years. I take a steroid inhaler (Pulmacort) once or twice a day,
[quoted text clipped - 21 lines]
>
> What say you?

I suspect it is much like Freon, which has never been proven to do anything
to the ozone layer. I suspect it is more like 95% political rather than an
actual hazard.

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