Phasing out generic, CFC-powered asthma inhalers

Sep 1, 2007 | Posted by: roboblogger | Full story: Los Angeles Times

The Food and Drug Administration has decided generic albuterol inhalers should be taken off the market. via Los Angeles Times

Comments
21 - 40 of 48 Comments Last updated Aug 15, 2013
M Malory

Maidstone, UK

|
Report Abuse
|
Judge it!
|
#21
Mar 14, 2008
 
M Malory wrote:
Please ask anyone you know who lives in the UK to sign this petition to save CFC inhalers (for UK residents only; the US petition is for US resdients only)
http://petitions.pm.gov.uk/cfcinhalers/
Kind regards,
Marcia Malory
Bump. Only two months to go.
Art

San Francisco, CA

|
Report Abuse
|
Judge it!
|
#22
Mar 14, 2008
 
Good luck, Marcia.

Let me know if there's anything I can do to help.

Art
Maryellen Freeze

Bristol, CT

|
Report Abuse
|
Judge it!
|
#23
Mar 22, 2008
 

Judged:

1

1

1

I came across this website as pure accident, I was attempting to research the affects of Albuterol on pediatric patients (my son, 4, has been relapsing lately with severe asthma attacks that has landed him in the ER three times this week alone)He was using Combivent, which worked part of the time, until a new DR told us that Combivent doesn't actually have any pediatric guidelines or dose, so he changed it to ProAir HFA. I noticed it didn't have the same oomph when I used the first few puffs into the air from the new canister. BUT my son uses a chamber to inhale his meds...should I still be concerned about him not getting that full propelled dose of medicine???? This is total crap. I agree, this whole obsession with cleaning our environment is getting over the top when they start taking away forms of meds that save OUR lives and the lives of our children.
Again however, my question is this....with my son using his chamber to inhale, should I still be worried he isn't getting the appropriate dose?
Have passed the link to your page on to others...differences can be made.
Maryellen Freeze

Bristol, CT

|
Report Abuse
|
Judge it!
|
#24
Mar 22, 2008
 
Oh, and just for the record. You can walk into any drugstore in the whole USA on any given day, and find a can of Aquanet or another brand, of hairspray on the shelf. I suppose a bee-hive is more important than being able to breathe? Sorry, this has truly gotten me angry.
Thanks for the forum to vent :)

“Art”

Since: Mar 08

San Francisco, CA

|
Report Abuse
|
Judge it!
|
#25
Mar 22, 2008
 
Maryellen Freeze wrote:
I came across this website as pure accident, I was attempting to research the affects of Albuterol on pediatric patients (my son, 4, has been relapsing lately with severe asthma attacks that has landed him in the ER three times this week alone)He was using Combivent, which worked part of the time, until a new DR told us that Combivent doesn't actually have any pediatric guidelines or dose, so he changed it to ProAir HFA. I noticed it didn't have the same oomph when I used the first few puffs into the air from the new canister. BUT my son uses a chamber to inhale his meds...should I still be concerned about him not getting that full propelled dose of medicine???? This is total crap. I agree, this whole obsession with cleaning our environment is getting over the top when they start taking away forms of meds that save OUR lives and the lives of our children.
Again however, my question is this....with my son using his chamber to inhale, should I still be worried he isn't getting the appropriate dose?
Have passed the link to your page on to others...differences can be made.
With all due respect, Maryellen, you're asking the wrong question. Do NOT give your son PROAIR- we've gotten more complaints on ProAir than any other rescue inhaler. In my opinion, it is total garbage- the worst in terms of efficacy.

Do NOT give your child PROVENTIL, slightly more effective in my opinion, but still not good, and it's the REPORTED FATALITY LEADER according to FDA MedWatch complaints (over 20 reported fatalities since 2005).

Give your child VENTOLIN (ok for kids over 4) the only HFA rescue inhaler without ETHANOL- A BRONCHOCONSTRICTOR that is in the other 3 in amounts over 1o% by weight. No, I'm not kidding. Watch your child carefully for side effects- sore throat, earache, headache, whatever- for a few weeks- I learned this the hard way- now I have tinnitus. But that's me, not most people, and it gives excellent relief and is the safest according to MedWatch data.

If he has side effects on Ventolin- he tries XOPENEX- IF HE HAS NO CARDIAC PROBLEMS (Xopenex has a concentration of serious cardiac side effects). But I take it and it seems ok- although I intersperse it with CFC Warrick Albuterol- STILL THE SAFEST/BEST rescue inhaler.

I STRONGLY suggest you get your son stabilized with WARRICK FIRST- go to our petition and call the drug store in the upper right corner- and if your MD refuses to immediately call in the Warrick Rx- get a new MD.

We'll post all above MedWatch data on our new website- if any MD (MDs only, please) want it now-(pdfs of MedWatch complaints by brand since 2005: Ventolin, Xopenex, Proventil, Proair, Atrovent, Flovent) have them email complete contact info to me at sponsor@saveCFCinhalers.org

Good Luck,
Art

P.S. All 4 package inserts are linked to our petition (lower right corner) Ventolin is LINK 6.

P.P.S. There's been no CFCs in hairspray, paint, refrigerators or anything else in the US for decades except: medical inhalers, Space Shuttle, Titan Rocket program.

“Art”

Since: Mar 08

San Francisco, CA

|
Report Abuse
|
Judge it!
|
#26
Mar 22, 2008
 
P.P.P.S. Read the petition comments (signatures tab at the top) to see what people say about Proair.

“Art”

Since: Mar 08

San Francisco, CA

|
Report Abuse
|
Judge it!
|
#27
Mar 22, 2008
 
sorry for the double post. Don't know why that happened.

“Art”

Since: Mar 08

San Francisco, CA

|
Report Abuse
|
Judge it!
|
#28
Mar 25, 2008
 
test
Maryellen Freeze

Bristol, CT

|
Report Abuse
|
Judge it!
|
#29
Apr 8, 2008
 
Thank you Art, for your informative reply. My son has now since stabilized and has his 4 year old physical this coming Friday where I will discuss all of the suggestions above. I have made a list of all intended medications and will make sure to get some answers. I have heard of Ventolin and have researched this online, you're right in that it is proven to be the safest among pediatric patients. Why am I having to research the best treatment for my son? Because there aren't enough MD's out there that will take the time to observe and treat children with asthma. Or...IMO I have not come across any thus far. Will provide update to you and let you know how it goes.
Blessings
Mary

“Art”

Since: Mar 08

San Francisco, CA

|
Report Abuse
|
Judge it!
|
#30
Apr 9, 2008
 
You're welcome, Mary. I'm glad your son's asthma has quieted down.

Most asthmatics are magnesium deficient. Magnesium is a miracle mineral (google 'magnesium asthma' and 'magnesium benefits', also 'fish oil asthma' and 'fish oil benefits'). It relaxes the smooth muscle found in the lungs.

I use 16 hundred mg magnesium oxide capsules (TwinLabs Magnesium Caps, available in any vitamin store) on an empty stomach in the morning if I feel very tight (because I skipped a few days of magnesium and fish oil) and I have relief in 2-5 minutes- no exaggeration. NOT magnesium TARTRATE, NOT magnesium with calcium or potassium, NOT magnesium in a multi-vitamin/mineral- just magnesium OXIDE- it says magnesium oxide in fine print on the back label.

He may not need 16 hundred mg for relief- 8-12 hundred mg may work for him. It may loosen/liquify fis bowel movements- but I'd be more concerned with making sure he has enough magnesium to quickly relax his lungs. It will help (cause) him to cough up any congestion in his lungs.

Make sure he gets more than enough daily magnesium (I take at least 8 hundred mg daily- he'll need less, possibly). By the way, ER department give IV magnesium SULFATE to status asthmaticus 'non responders', often with successful outcomes.

In my opinion, the failure of asthma docs to routinely test for and prescribe non-Rx magnesium oxide for their asthma patients is probably their most glaring and serious mistake.

Fish oil should be taken for asthma control (inflammation) daily- I take 4 g/day- I use Jarrow- balanced, with both omega 3 fatty acids. It should be taken with Vitamin E- I use Jarrow FamilE. Use any good brands of the above, but use them daily in sufficient doses, and I can guarantee that your son will feel much, much better and will need much less Rx drugs. When I get lazy and skip a few days of magnesium and/or fish oil- I really feel the difference.

Most MDs are overworked and don't have time to read package inserts of all the drugs they prescribe, much less research the 'tip of the spear' warning signal data the FDA relies upon: Medwatch complaints. It took us many hours to import from the FDA's AERS Database and decode and filter out the obvious garbage data and assemble the clean complaint data into single page, plain English reports, currently covering all MedWatch complaints from April 2005 to September 2007, and assembled into 6 PDFs for: Ventolin, Xopenex, ProAir, Proventil, Atrovent, and Flovent. We will update quarterly and increase the drugs covered (including nebulizer solutions) retroactive to April 2005.

This plain English data of MedWatch complaint case reports is UNAVAILABLE anywhere else. Any MD who treats asthma patients and who wants the newest data in order to make the best treatment decisions for his patients should want to see these PDFs, and we're happy to send them to any MEDICAL PROFESSIONAL (not just MDs, by the way) and REPORTERS who send contact information to us at:

sponsor@saveCFCinhalers.org

Any patient who would like these PDFs should send their request to the same email address and SPECIFY WHICH OF THE 6 PDFs THEY WANT AND BE SURE TO INCLUDE THEIR PETITION SIGNATURE NUMBER.
To sign the petition (the only way to get a petition signature number) go here:

http://www.ipetitions.com/petition/saveCFCinh...

Mary, please sign the petition to save CFC inhalers if you have not done so, and PLEASE file a MedWatch complaint against ProAir (the link for the online complaint form is on the right side of the petition). It takes 2-3 minutes. Do the best you can, be as clear as possible when describing your son's reaction to/problems with ProAir.
Good luck on Friday, keep us posted on how your
son is doing.

Best Regards,
Art
MMM

Broomfield, CO

|
Report Abuse
|
Judge it!
|
#31
Apr 9, 2008
 
Isn't it adding insult to injury that the HFA's cost more... and they're offering ONE free... lot of good that will do me when laying on the floor gasping for air becasue the damn thing does NOT WORK!!@!
MMM

Broomfield, CO

|
Report Abuse
|
Judge it!
|
#32
Apr 9, 2008
 
"Space Shuttle, Titan Rocket program"

WOW!!! I can't believe they're going to allow us to suffer while the space shuttle and the rocket program continue in full swing....

THERE IS A PROBLEM WITH THESE PRIORITIES

“Art”

Since: Mar 08

San Francisco, CA

|
Report Abuse
|
Judge it!
|
#33
Apr 10, 2008
 
This is a quote from former Surgeon General C. Everett Koop (I will be contacting his office this week). Dr. Koop (a pediatric surgeon) may be able to shed some light on whether it really WAS intended from the very beginning that CFC inhalers were to be banned once a suitable alternative was found. I've done a lot of research into this- and I don't believe that this is true at all. I think it is revisionist history.

It IS true that the drug companies saw this huge opportunity and did everything they could to rush the CFC inhaler ban through, constantly hammering the radical EPA to hammer the less radical FDA to get with the program. They (the drug companies) set up a consortium in the late '80s to find a suitable alternative to CFC propellant. Out of 15,000 propellant candidates, they found only two (2) possible candidates!(I guess, with the benefit of hindsight, they really found zero [0].)(All companies settled on HFA-134a).

All of the "extensive testing" of HFA-134a that the FDA spokesthings refer to ("spokesthings" include, by the way: big name academic MDs on the drug company dole one way or another. MDs who observe the code of silence are almost as bad: consultant MDs afraid of losing the favor of the FDA which they need to represent drug companies, or MDs told to shut up and sit down by the VA [I've talked to two of these MDs]- many PADAC MDs work for the VA- and all federal agencies stick together)- but as I was saying- all of the so-called "extensive testing" of HFA propellant that the spokesthings refer to was done on NON-ASTHMATIC TEST SUBJECTS. And the clinical trials using actual albuterol with the HFA was only done on VERY MILD ASTHMATICS (NO COPD PATIENTS were ever used in clinical trials although they ALL use HFA rescue inhalers).

Each company's trials involved only a few hundred subjects divided 3 ways (HFA albuterol brand, CFC albuterol contol, HFA only (no albuterol). These "trials" usually only lasted 2 weeks. And the FDA used a "bridging" approach to speed things up (they had the drug companies breathing down their necks): they "bridged" CFC albuterol's wonderful safety record over to HFA albuterol, thereby loosening up the normal regulatory process, because, after all,'it's the same medicine- only the propellant is different!'.

Yes. The propellant is different. And the inclusion, for the first time, of a bronchoCONSTRICTOR (ethanol) in all new ASTHMA 'RESCUE' INHALERS except Ventolin, is just a bit different, also. And new ELASTOMERS are used (uniquely formulated rubber seals) which may- when interacting with the propellant, release DANGEROUS CHEMICALS, according to Gene Colice MD, the 'father of CFA Albuterol'.

Dr. Koop (1997): "there is no comparison between the infinitesimal improvement in ozone depletion that would result from the FDAs ban and the direct impact of forced elimination of medications on 14 million American asthmatics.

Secretary of Health and Human Services Shalala (1997): "the proposal would be more than dangerous."

They were responding to the Clinton-Gore first attempt to rush through the CFC ban process at the time, JUST MONTHS after Proventil HFA was approved. They were shaken to their core when 10,000 patients and MDs said 'pushed back'. This didn't stop Clinton-Gore from shoving the CFC inhaler ban process down the throats of all developed country signatories of the Montreal Protocol a few months later, in September 1997.

FDA PADAC (Pulmonary and Asthma Drug Advisory Committee) transcripts refer to the FDA being badly shaken by the 1997 protest. They ain't seen nothing yet.
carmen

South Holland, IL

|
Report Abuse
|
Judge it!
|
#34
May 18, 2008
 
stillwheezy wrote:
The FDA needs to change their decision
and return generic albuterol cfc asthma
inhalers to the asthma patients that
depend on them to breathe.
The HFA inhalers that they have given
us don't work at all and are putting
asthmatics at life threatening risk.
The new HFA inhalers are pathetic, I
wasn't sure what to expect when my
pharmacist gave me my new HFA ProAir inhaler. But when I had an asthma attack, that HFA inhaler did not give me any relief. No Relief at all in fact it stung my throat, made me buckle over into a gagging coughing attack that I couldn't control, and the worst part was, it didn't even go into my lungs, my asthma was getting worse. I
was seriously weak from lack of oxygen, and on my hands and knees on the floor. I couldn't breathe.
The IVAX company that put out that HFA inhaler should be shut down!
Luckily I had some of my
generic cfc inhaler left - I'm not kidding you, it restored my breathing in seconds! Anyone with asthma will be able to testify to that.
I have serious asthma and cannot live without my
albuterol cfc inhaler, and many many other people with asthma are depending on this inhaler to open the airways in an asthma attack.
Without our trusty cfc albuterol asthma inhaler, asthmatics are left without a rescue inhaler.
That's what the cfc albuterol inhaler is, it is the only available lifesaving rescue inhaler and
if they take that away, they are going to kill asthmatics. Do you realize how serious this is? They are taking away our breathing device, and not replacing it with anything that works.
The hospitals and Emergency Medical Systems are going to be overwhelmed with asthma emergencies. There will be more absenses from work due to asthma, disability, and more asthma related deaths. And then there will be the biggest class action lawsuit you ever saw.
Even if asthma is improved with steroid medicines like Advair, we still need a rescue inhaler. Don't let anyone tell you that ProAir HFA, Proventil HFA and Ventolin HFA are the same as our cfc albuterol. They are not, and they will
not save you in a lifesaving asthma attack.
The Medical System, FDA, and World Health Organization must amend their decision and continue to provide medical grade cfc albuterol because they have not provided us with an equilivant or better asthma inhaler. They are putting asthmatics in a very dangerous life-threatening situation.
They have no right to take away our lifesaving asthma inhaler, this is no different than taking a lifesaving medicine away from a diabetic, or heart patient. This is a very scary situation for asthmatics, read the petition
http://www.thepetitionsite.com/petition/30059...
That's only a tiny fraction of the people who are going to be affected by this. You will cry if
you read the petition - I read the whole thing through, and feel the horror of this situation.
The medical system and pharmaceutical companies are not medically prepared for this. If you do not have asthma you don't understand what we're going through. I don't want to suffocate to death. And I don't want other people with asthma to either. I have been in tears everyday because of this, especially everytime I read about a teenager or child who can't get a clear breath because the stupid HFA inhaler is failing them and they can't get a generic albuterol inhaler.
This is a life and death situation - You must bring back cfc Albuterol Rescue Inhalers.
While I have been given relif from proair< i have found that 40$ is quite expensive when you need this plus other medications filled on a monthly basis. This is not covered at all through my health care prescription plan and there is no generic available at this time. My pharmacist switched me to this. I have 2 other family members that use inhalers as well. Than's $120.00 per month just for inhalers. We need some type of compromise.
helpmebreath

Hampton, VA

|
Report Abuse
|
Judge it!
|
#35
May 30, 2008
 
Thank God there are people out there like me! Ethanol in inhalers is going to cause so many problems - and I am ALLERGIC to ethanol - so what am I supposed to use??? I am allergic to corn and all it's derivatives -! So how will I be treated in an emergency???- I used to use the flonase, and beconace nasal inhalers that gave me a new life - and now they are off the market. They only have the sprays - loaded with dextrose and they are garbage. Does anyone know of a rescue inhaler w/o ethanol, and a steroid inhaler w/o ethanol! need help - today I am wheezing and using the nebulizer with xeponex - but I can't carry that around!

“Art”

Since: Mar 08

San Francisco, CA

|
Report Abuse
|
Judge it!
|
#36
May 30, 2008
 
helpmebreathe, Ventolin HFA is the only rescue inhaler without ethanol.

Flovent discus is a powder inhaler (corticosteroid)- no ethanol, no HFA.

Warrick CFC and Armstrong CFC are still available-(no ethanol, of course,) see the petition- right side. Sign it- we'll be emailing our campaign strategy to fight this CFC inhaler ban before June 15 to all petitioners. Millions of patients are refusing to buy HFA albuterol- we are cautiously optimistic that that we can recruit enough of them to win our fight against this incredibly dangerous and illegal ban.

The petition outlines our position that the FDA committed malfeasance in office- using documented quotes from FDA officials from the June 10, 2004 PADAC meeting (plus much more). This ALONE would render the CFC ban ILLEGAL.) If we get enough petitioners, Congress and the Administration will develop a sudden, overwhelming compassion for pulmonary patients. This is all about the numbers.

“Art”

Since: Mar 08

San Francisco, CA

|
Report Abuse
|
Judge it!
|
#37
May 30, 2008
 
Joan

United States

|
Report Abuse
|
Judge it!
|
#39
Jun 19, 2008
 
I very seldom had to use my albuterol and I just reordered it and found that they are sending me the proairhfa and it cost twice as much as the albuterol and even though I don't use it often, now I am really scared it wont work when I do need it!!
I live on a limited income and really wish they had not done this! For 90 day supply it cost 120,00!!
God help us!!!

Since: May 07

Location hidden

|
Report Abuse
|
Judge it!
|
#40
Jun 21, 2008
 
I just found out I can no longer take albuterol, it cause my heart to skip. So there it is, No longer on my list of things to take....

“Art”

Since: Mar 08

San Francisco, CA

|
Report Abuse
|
Judge it!
|
#41
Jun 22, 2008
 
Well, what about pirbuterol (Maxair)- which is much gentler in terms of cardiac effects than albuterol- and is still available in CFC form?

Tell me when this thread is updated: (Registration is not required)

Add to my Tracker Send me an email

Type in your comments below
Name
(appears on your post)
Comments
Characters left: 4000
Type the numbers you see in the image on the right:

Please note by clicking on "Post Comment" you acknowledge that you have read the Terms of Service and the comment you are posting is in compliance with such terms. Be polite. Inappropriate posts may be removed by the moderator. Send us your feedback.

13 Users are viewing the Diabetes Forum right now

Search the Diabetes Forum:
Title Updated Last By Comments
Medtronic Quick-Sets MMT-397 For Sale (Jan '14) Wed Chris 26
Medtronic MMT-399 Quick Sets available Tue S_Lynn 9
Medtronic Mini-Link Transmitter for sale (Jul '12) Tue Ian katz 19
Medtronic iinsulin pump for sale Mon John44691 1
Transmitter and sensors for sale Jul 28 Ian katz 6
Medtronic MMT-382 Silhouettes, 43", 13mm 10 Box... Jul 27 Test Strips Rescue 1
Animas OneTouch Ping Pump & Meter for Sale (Dec '11) Jul 27 kim34 29
•••
•••