Albuterol Switching to New HFA Formulation


ROUGH TRANSITION TO A NEW ASTHMA INHALER
By Laurie Tarkan
Published: May 13, 2008
The New York Times
Millions of people with asthma and other lung diseases will have to switch inhalers by the end of the year. And for many, the transition will not be smooth.
The change — mandated by the federal government in 2005, to go into effect next Jan. 1 — is to comply with the 1987 treaty to protect the earth’s ozone layer. It bans most uses of chlorofluorocarbons, or CFCs, which are used as propellants in many inhalers.

CFC-free inhalers have been available for more than a decade. But four million to five million users have yet to switch, according to the consumer advocacy group Allergy and Asthma Network Mothers of Asthmatics.

For one thing, the old inhalers cost much less — an average of $13.50, or one-third the price of a CFC-free inhaler, which uses propellants called HFAs, for hydrofluoroalkanes. (CFC inhalers are generic; HFA inhalers are brand-name.) People with asthma use an average of three or four inhalers a year, but some patients use one a month.

Moreover, the new and old inhalers differ in feel, force and taste, and how they are primed and cleaned. Advocates for people with asthma say doctors and patients have not been educated about the changes.

“What the government failed to do is to mandate anyone to tell patients and physicians this transition was happening,” said Nancy Sander, president of the asthma group. “There is no education, no monitoring of patients, no financial assistance to patients who have to pay higher prices for the new drugs.”

As a result, she and others say, there have been unnecessary fears about the newer inhalers, preventable trips to the emergency room and even some hoarding of CFC inhalers.

Callers to a hot line run by Ms. Sander’s group have complained that when they were switched to the new inhalers, the differences between the two types were never explained. Many thought that their device was broken or that their symptoms were not being relieved by the new inhalers.

The Food and Drug Administration says that since January 2007 it has received 415 complaints about HFA inhalers’ costing too much or not working properly. After a public meeting last month in which doctors and patients said most people were unaware of the transition, the agency has been stepping up educational efforts, with several public service announcements expected by the end of this month, said Deborah Henderson, an official at the Center for Drug Evaluation and Research.

Both types of inhalers use albuterol, a short-acting medication that can prevent an asthma attack when used preventively — before exercising, for example — or at the first sign of breathing trouble.

But the cost difference has meant huge gains for drug companies. As people switched to HFA inhalers in 2006 and 2007, sales of all albuterol inhalers jumped from about $500 million to $1.1 billion, according to I.M.S. Health, a health care information company. Of the 40.5 million prescriptions written for albuterol inhalers last year, it said, about half were CFC and half were HFA inhalers.

And even though there are important differences between the four brands of HFA inhalers, some insurers cover only one of the four. Advocates say the higher cost may keep patients from buying inhalers or force them to cut back on other medications or switch to a less effective over-the-counter inhaler that uses epinephrine.

Several members of Congress are asking the Bush administration to require insurers, including the Medicare and Medicaid programs, to cover the new inhalers equally. Representative Steve Kagen, a Wisconsin Democrat who is also an allergy and asthma physician, said it was important “to make sure there’s as little co-pay as possible.”

The four HFA inhalers are Ventolin by GlaxoSmithKline, ProAir by Teva, Proventil by Schering-Plough and Xopenex by Sepracor. (Xopenex uses a different chemical, levalbuterol.) All companies have give-away programs for those in need and are providing free samples that doctors give to their patients. There is also financial assistance available through the Partnership for Prescription Assistance (1-888-477-2669).

Studies show that HFA inhalers are as effective as CFC inhalers and have the same rate of side effects. But if they are not used properly, patients will not get adequate doses. There are three critical differences.

HFA inhalers must be pumped four times to prime them — a number that was not so critical with the more forgiving CFC inhalers, said Dr. Leslie Hendeles, professor of pharmacy and pediatrics at the University of Florida. And each brand of the newer inhaler requires a different frequency of priming.

HFA inhalers have a weaker spray. “It’s very soft so people think it’s not working,” Dr. Stoloff said. Where CFC inhalers deliver a powerful force that feels as if the airway is being pushed open, the newer ones provide a warm, soft mist that also has a distinct taste.

They also require a slower inhale. “You have to take a nice slow, deep breath and hold it,” Ms. Sander said. If people worry that it’s not working, they may not take the second puff, may fail to wait the necessary 30 seconds between puffs or may take too many puffs. ,And their anxiety may rise, further constricting their airways.

HFA inhalers need to be washed with warm water and air dried once a week. The medication is stickier and will clog the hole, reducing the amount of medication the spray delivers.

There are also important differences among the brands, though some doctors simply write Albuterol HFA on the prescription, leaving the pharmacist to choose the brand. Only one, Ventalin, has a dose counter, which helps users keep track of how much medication is left. ProAir appears to be on many insurance companies’ lists of approved medications, but it has the softest spray, Dr. Stoloff said.

To read the full article, go to NY Times.com

Acknowledgement: thanks to Dr. Munitz for calling our attention to this article

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17 thoughts on “Albuterol Switching to New HFA Formulation

  1. Let’s see, I’m allergic to both corn and alcohol. Since all of the new inhalers contain ethanol (corn alcohol) as their propellent, I am SOL. I am not the only one, BTW.

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  2. How are you allergic to ethanol? What are your reactions and have you had allergy testing to this? The reason I’m asking is that hardly anyone is allergic to ethanol and you might be having a different reaction to it which is not allergic and precludes your ability to use the inhalers.

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  3. I have used Albuterol for several years w/o problems. However, since using the newer HFA-propelled form (Ventolin HFA) for about five months, I’m now experiencing hives, skin swelling, light-headedness immediately after using the inhaler. I’m in a quandry. I need the Ventolin, but now it seems I’m allergic to it.
    For background, I am allergic to mold, dust/mites, sulfites, animal dander/feathers. Have been asthmatic for 40 years.
    What hypersensitivity studies exist on HFA?

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    1. I am unaware of any reports of people having any allergic reactions to HFA powder. I would see an allergy specialist to do skin tests or inhalation challenges to document that your symptoms are related to the HFA. And if this is so, contact the company to determine what possible components you may be reacting to.

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    2. Try Proventil….it’s still an HFA but something in it is different. I became very ill after using Ventolin and truly felt like I was poisoning myself. I started coughing up something that tasted like Moth Balls. I finally called my pharmacist and insisted on being switched back to Proventil. After two days, I feel like I’m on the road to recovery!

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  4. To Dr. (?)/ Mr. Abramson from savecfcinhalers.org:
    Your comments have been marked as spam and deleted. I do not tolerate abusive language from anyone nor do I respond to anyone who uses abusive language. If you wish to discuss this issue in an objective manner without invective, please attempt to do so.
    Your manner reflects poorly on the issue that you are attempting to promote.

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  5. I’ve used albuterol for several years without problems. However, I used an HFA inhaler (ProAir) for the first time last week, and I passed out. Is this common? I did not know it had to be “primed”, could this have been why I passed out?

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  6. The new HFA inhalers do not work. Period. I guess I will now have to buy the old ones from an online pharmacy in Canada, good job US government.

    I have had an asthma attack, used the HFA (ProAir) and felt no relief whatsoever. Luckily I have a stock of three or four of the real inhalers.

    This ban needs to be reversed and soon, horrible decision. Why don’t the output on cars instead of something that saves lives.

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    1. Try Proventil….it’s still an HFA but something in it is different. I became very ill after using Ventolin and truly felt like I was poisoning myself. I finally called my pharmacist and insisted on being switched back to Proventil. After two days, I feel like I’m on the road to recovery!

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  7. I been having issues with proair inhaler first time I used proair I had to be rushed to the hospital put on oxegen for 3 days Dr again put me on proair and I broke out in hives I refuse to use any new inhalers since thenI will stick with neb treatments

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  8. When I moved to the south in 2005, I stopped using all asthma medications because my asthma was in control. Unfortunately in April 2008, I because ill with bronchitis and was prescribed an HFA Inhaler instead of my regular CFC inhaler. Within a week I was feeling very very sick. Over a period of months I was using the HFA inhaler all the time. I continued to go back to the doctor and was given antibiotics over and over again–but my health continued to decline. I kept going to the Emergency Room and being given steroids–I was even hospitalized twice in PCU because of the severity of my illness.

    Eventually, I was up all night because I was choking and was so sick and I couldn’t breathe. I’ve had asthma most of my life and I never had my asthma spiral out of control this quickly nor this severely. My hair even fell out. I seriously began to think I was going to die. Finally I began to research options of what else I could do, since nothing I was doing worked.

    After researching these new HFA inhalers — I found that I was not the only one experiencing serious life-threatening side effects from this HFA inhaler. I also found that the HFA Inhaler contains 10-14% ethanol. But most shocking of all was that HFA inhalers were never tested on chronic asthmatics or COPD patients. It was tested on people without asthma and those who presented with very mild asthma. Amazingly, the FDA accepted to allow these HFA Inhalers to be quietly foisted upon an unsuspecting public. Believe it or not—post-clinical trials are being conducted with asthmatics now that the HFA inhalers are on the market. This inhaler is vastly different from CFC inhalers yet was promoted to FDA as though it were the CFC Abuterol inhalers. The difference is the inactive ingredients.

    The manufacturers of the HFA inhalers claim that this is the same medicine, it may be the same medication, but the propellant has changed making this a new medication! I now know that FDA allowed these drug companies to corner the market with a patented, ineffective substitute and did not provide an adequate replacement for people who responded negatively. It was a business decision to make this change—not a medical one!!

    Last year, I began to communicate my concerns with local elected officials– they kindly gave me the FDA’s supportive response stating that they stand by their decision and they will not consider any further change (totally insulting!!). FDA states this medication is just as good or maybe even better than CFC inhalers!!! They claim this is best for the environment yet there is no conclusive evidence that CFC inhalers used by asthmatics made a difference to the ozone layer. I am very interested in saving the environment, but why not first find a real effective replacement for CFC inhaler. FDA should not try to clean up the earth at the cost of asthmatics lives.

    Before HFA inhalers I was a productive gainfully employed citizen. I am now seeing an immunologist due to a rare autoimmune problem that has recently developed. Many people who have used HFA inhalers are now presenting with autoimmune issues that were not present prior to HFA inhaler use. I have severe lung obstruction and only recover 35% after a treatment–I am completely nebulizer dependant, and my hair has not completely grown back. I am seeing a pulmonologist and a team of doctors for all my ailments. I have been forced to go on disability because I struggle everyday to breathe. My life has been completely altered because of HFA inhalers—I do thank God that I’m alive…..

    Many people like me put their trust in the FDA and medications—but my experience with HFA inhalers have taught me to question all medications. All Asthmatics have been affected by this horrible unjustifiable prohibition. We asthmatics need to put pressure upon our elected officials – otherwise we will die!! Our choices of medications are now very limited, therefore our time is also limited—

    I wish all of you the very best…

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    1. Victoria, your story in, the beginning, sounds like me and what I’m currently going through. They gave me Ventolin and I truly felt like I was poisoning myself! I kept telling the doctors that something was different, I got no relief, and I actually felt worse while on it. I became very ill and was coughing up something that tasted like Moth Balls! My body reeked of it too! I finally called my pharmacist and insisted on getting off of the Ventolin – MAGIC. I’ve been off of it for two days now, and although I’m still coughing, I’ve made a drastic turn around in how I feel and the severity of my cough. The Proventil I’m on now (and was previously) is still an HFA, but something in it is different. I never once had a bad reaction to an inhaler until the Ventolin.

      I wish you well in your healing.

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  9. My 7-yr-old daughter just started on a new albuterol inhaler and about 5 days into it I gave her her first puff and she totally passed out flat on the floor. I had turned to do something right after I gave it to her so I wasn’t watching her to catch her from falling. Turns out she probably has bronchitis and was given a Z-Pak and won’t be using the inhaler anymore anyway. Talk about weird and scary! Seems like the albuterol is to blame but why that would happen is unclear.

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  10. I am very glad I read everyones comments. I have not tried the hfa proventil due to having a hx of having a bronchospasm to atrovent. atrovent had 3 different propellents in it. i have successfully tried 2 of the 3 but it is the 3rd one that they made the hfa out of. i have now lost my steroid inhaler of 18 years due to the cfc ban and am on a powder which is not working. i tried to use my aerosl machine and the txment binded to the powder in my lungs. it was not pretty today. has anyone heard of anything happening with the hfa’s and if they are working on making another type of propellant? thanks

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  11. I have used Albuterol for many years with no problems. The pharmacy gave me Ventolin FSA instead this time. I feel “drugged” for hours after using Ventolin HFA! I spend at least an hour everyday exercising, but yesterday passed out on a walk around the block! Ventolin HFA is not like Albuterol! I read some of the commments about skin problems, and now wondering if the new skin irritations are from this drug. My hands had little bruised looking spots after using the Ventolin. The spots semm to be going away after 12 hours of not using the inhaler.

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