Sunday, February 25, 2007

Levalbuterol (Xopenex) No Better Than Albuterol, Says Public Citizen/ WorstPills.org

Hah! Guess they've never had to deal with kids on albuterol. (For the uninitiated, you may as well give them a twelve pack of Red Bull and a couple of Hersey bars....)

Levalbuterol Is No More Effective Than Older, Cheaper Asthma Drugs and Should Not Be Used, Public Citizen Advises on WorstPills.org
“Worst Pills, Best Pills” Subscribers Receive Life-Saving Warnings About Dangerous Drugs Before They Are Removed From the Market

WASHINGTON, D.C. –Levalbuterol HFA (Xopenex HFA) inhalers are no more effective than older, less expensive drugs used to treat asthma and other diseases and should not be used by consumers, Public Citizen writes in a new February posting on its WorstPills.org Web site. The consumer advocacy organization cited information published in the March 2006 issue of Medical Letter on Drugs and Therapeutics.

In 2005, Americans filled more than 2.2 million prescriptions for levalbuterol at a cost of more than $293 million. Marketed by Sepracor Inc., levalbuterol has the same atomic components as the asthma drug albuterol, which has been on the market longer and costs less. The difference is that, while albuterol has both of the two mirror images of the molecule, levalbuterol has only one. Levalbuterol is available in two forms, Xenopex [SIC]HFA, a pocket-sized inhaler approved by the Food and Drug Administration (FDA) in March 2005, and Xenopex, a liquid drug approved in 1999 that is converted to a fine mist when passed through a device called a nebulizer. Levalbuterol is short-acting and is used to relieve symptoms experienced during an asthma attack. In 1999, Public Citizen placed levalbuterol on its “Do Not Use” list of drugs because there was – and still is not – any compelling evidence that levalbuterol is safer or more effective than albuterol.

“Creating a drug that is nearly identical in nature to a drug that is already in existence and then marketing it as a ‘new’ or ‘breakthrough’ drug is a strategy that neither helps consumers nor produces better drugs,” said Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group. “In marketing levalbuterol as such, the manufacturer is manipulating patients into unnecessarily paying hefty prices.”...

Again, I say the value of Xopenex is not the effectiveness of the drug -- we know it's equal to the cheaper, generic albuterol in that way. But the side effects...where albuterol has the kids bouncing off the walls (especially lovely if they're already on oral steroids) levalbuterol yields negligible negative effects.

To be able to give your asthmatic child a neb at 2:00 AM and know that they'll actually be able to sleep after that is worth the higher copay.

42 comments:

Zany Mama said...

We never use albuterol. We are the biggest fans of Xopenex on the planet. I completely agree that worstpills.org must have never had exposure to someone on albuterol.

We always dread going to the ER (for obvious reasons) but also because they only give albuterol and our son is a crazy maniac on the stuff.

Aimee said...

Totally with you. Xop is da bomb. (Says the 35 year old suburban mom...)

Anonymous said...

I'm a 4th year medical student, and I found this interesting page while browsing the web.

It's a very common misconception that people consider Xopenex to have less stimulating side effects than albuterol (rapid heart rate, for example). Actually, both albuterol and xopenex have the exact same active ingredient in it (the "R" enantiomer molecule). The only difference is that albuterol also has an inactive "S" enantiomer that doesn't contribute to therapy.

The practical difference comes in the dosing. Xopenex is dosed at a lower concentration than albuterol, therefore the side effects are minimized. If Xopenex was dosed at the same concentration as albuterol, the same side effects would be observed.

A lower dose of albuterol would have similar effects as xopenex in the sense that similar effectiveness and minimal side effects would be achieved. Granted, it's hard to adjust the dose of albuterol while using inhalers or nebulizers.

As always, consult with your physician if you're having concerns about this. If saving money is your concern, albuterol is cheaper and could potentially be used in the same way as xopenex if the dose is adjusted (after all, they're really the same drug. Xopenex is really albuterol at a lower dosage with a useless enantiomer removed from the solution).

Aimee said...

Wow - thanks for the great comment! We've switched back to good ol' generic albuterol recently for the affordability...but we have noticed that with Iain, particularly, we do see a lot wakefulness and irritability. We may try him on Xopenex and see if there's any difference....Can't hurt.

Melissa said...

Xopenex is AMAZING. I realize that according to studies a lot of people react identically to albuterol and xopenex; however, I was part of the clinical trials and xopenex works fundmentally better for me. I not only have improved lung function, but I also don't have the insane increase in heart rate. With albuterol the doctors were often limited in how often they could give me treatments because of my high heart rate. Also with the introduction of HFA xopenex inhaler I can no run for the first time in my life. So it is not bogus drug.

Aimee said...

Thanks, Melissa. With my little ones, I definitely see the difference, too. They're psychotic on albuterol, but practically normal on Xopenex.

Thanks for the comment. Hope we hear more of your feedback now that you've found the blog!

Anonymous said...

Many thanks to all for your comments. My son, 2 yrs old, has had mild intermittent cases of asthma over the last year. Through each attack he seems to go into fog like state that takes me weeks to get him out of and I couldn't put my finger on why? He's extremely communicative and it was as if I was loosing him, getting him back on track, then he'd get sick and be gone again. This has happened at least six times this year. I was requesting referrals to neurologist or thinking he was developing late onset Autism. I began to sound like a crazy woman. I starting researching stuff and thinking he had all kinds of issues outside of the asthma. But since the attacks were our trigger I booked an appointment with a Pulmonary Pediatrician with all my notes and concerns. The same week as our first visit to his office we ended up bringing a cold home from preschool that I couldn’t kick on my own. We have a nebulizer at home that we began administering Albuterol through again – and sure enough within 24 hours he had no original thought, began mocking things, and noted to me there were new deficits in his hand coordination and lower legs. I really panicked then. So I had to call the new doctor back 2 days later to see us because we seriously couldn’t breath. With each treatment I continued to see new deficits in his thought as well as action. Meanwhile, his breathing continued to worsen, and he was “clouding” up bad. I stopped the Albuterol at midnight and thought I would wait until morning and let the doctor see for himself. I was lucky enough to find this website last night and this morning at our appointment I convinced them to switch the Albuterol to Xopenex. As soon as we got there they scolded me for not administering it and I refused the Albuterol. They along with my husband administered it as I unhappily sat crying telling me that the side effects would be noticeable once they finished a treatment. Nothing changed in that visit concerning his behavior. However, I left with a prescription for Xopenex and headed home. (Of course, not before they said I was psychosis – and told my husband that I needed help!) But within 3 treatments of Zopenex, my kid was back from the fog we were attempting to creep back into with this infection! He definitely has some underling issues and hate that I probably made a complete butt of myself to get to the bottom of it. And don’t get me wrong we are visiting with an allergist next week and there are definitely some more underlying issues. But there is an amazing difference in the way he reacts to these two drugs. It took me showing my butt to figure it out – and I couldn’t have done it without comments like yours. They say that there isn’t a difference in these two drugs when they prescribe them and you hesitate because you think they know best. Needless to mention the considerable difference in price. However, we’ve learned the hard way that Albuterol is some pretty heavy stuff as far as our little boy is concerned. I will pay 10 X more for Xopenex if it means keeping my son’s mental health alive and strong. I highly recommend this medication switch to any parent of a small child and hope that it doesn’t take you as long to figure it out as it did us. I wish I had found this site before last night – the switch was WAY over due.

Anonymous said...

The posts advocating Xopenex sound a lot like the propoganda from the drug reps selling Xopenex from Sepracor. There is no justification for charging $3.50 per dose as compared to 13 cents per dose for albuterol. Go to the message boards at cafepharma.com and see how the Xopenex reps are out to trick you.

Xopenex is FDA approved for use at a maximum of 1.25 mg 3 times a day. If you need more frequent dosing, you have the same efficacy and side effect profile as albuterol.

Anonymous said...

When I took albuterol, I ended up in the ER thinking I was having a heart attack. When I got there, my heart rate was 200+ and they told me it was a good thing I came in, because I could have had a heart attack. A few months later, having suffered from an attack of acute bronchitis, I was prescribed an inhaler and was weary, asking them to please not put me on albuterol again. So they gave me Xopenex, and I cannot even begin to rave about what a significant difference there was. I had no side effects, no rapid heart rate, and great lung function, even with asthma and bronchitis. Xopenex, in my opinion (and based on personal experience), is much safer and works just as well as albuterol.

lillylangtree said...

I was diagnosed with Adult Onset Asthma in 2007 and given Albuterol and it seemd to make me worse. Then I was given Singulair had an allergic reaction which I believe caused Churg-Strauss Syndrome. I lost the use of my legs, drop foot and right hand parathesis. Now I take no meds since Nov 2007 (against the advice of all Doctors) but suddenly developed Asthma wheezing. I was given Xopenex which is better that Albuterol, perhaps it is a lower does, but rafely does it cause me to be nervous and if it does, passes very quickly. However, I find that I am using it almost every other night or every night (one puff, not two) and I don't want to take a Prednisone inhaler as I don't want Pred in or even to touch my body. Is it too much to take this inhaler that often? I have never had a full blown asthma attack where I couldn't breath, just shortness of breath and lot's of coughing and once I cough up the mucous I am fine. Is that asthma? No tests were ever made.

Carla said...

My son and I have both used albuterol without any ill side effects. He is off it now, but I still needed something so they gave me xopenex. I'm not sure why they switched, but I've been using it for 18 months now. I find it works fine, but more slowly than albuterol. With albuterol, I could breathe again almost immediately. With xopenex, it takes a couple of minutes to work. I always have to take two puffs for it to work, as with albuterol I could sometimes do just one. The cost is not an issue for me, but I think I will ask for albuterol again just because I feel it works faster and I feel no ill effect from it so that is not a deterrent.

Aimee said...

Thanks, Carla - great to have your feedback! Do you use the neb or the MDI?

Anonymous said...

I have had serious lung issues for the last 5 years after a long illness. The doctors gave me Albuterol as a rescue inhaler on top of my other inhalers. I tried it, it was horrible, heart racing, jitters, made me naseaous it was awful. I would rather suffer than use it. While in the hospital for a week long stay I told the respiratory person I just couldn't handle the Albuterol and they came back with Xopenex, it was like night and day. I spoke to my pulmonologist and he prescribed the inhaler for me. It was again like night and day. Medicare refused to pay for it, my doctor wrote several letters on my behalf as over time he agreed that I did better with the Xopenex and after being denied several times Medicare finally approved it for me. My doctor said that was the first time he has ever gotten it approved and I certainly hope if others need it, it will happen for them too. I do not know why the price is so much more but it works and I am thankfull

Anonymous said...

I am a respiratory therapist in a pediatric icu and pediatric floor. I detest Xopenex. IMO it is all marketing hype. Parents that swear their little snowflake goes crazy after albuterol don't seem to notice that the kid sleeps just fine when I administer it in the middle of the night (they probably don't notice because they are asleep too). The only possible justification I see for the exhorbitant cost of Xopenex is for those with a cardiac history and even that's iffy.

barrierps said...

My daughter has been using Xopenex since she was 2 she is now 10 and it is expensive but I would not risk her health by switching to anything else! This is the best medication for neb treatments, any time she is sick we start her treatments right away and we know that she will breathe easier in no time :)

Anonymous said...

My 2 year old just started breathing treatments last week for asthma brought on by an upper respiratory infection. The doctor at the immediate care center prescribed albuterol and I administered it as directed. She could not sleep, began talking jibberish like a baby and became unbelievably hyper. I did not like the side effects, so I took her to our pediatrician and was prescribed Xopenex. We have done several treatments and have not had any of the side effects that we had with albuterol. I think because my daughter is especially small for her age the side effects were much more prominent. I will pay a little more for Xopenex to ensure that we don't have to deal with a child that I do not recognize! Parents are the ones that are with their children more than anyone else, so we should be able to determine what medications we give our children based on the side effects we don't want to deal with!!

Anonymous said...

ALBUTEROL MAKE MY SON'S HEART RACE AND XOPENEX DOES NOT. THE SIDE EFFECTS OF THE ALBUTEROL ARE INTOLERABLE FOR MY SON. I AM THANKFUL THAT XOPENEX EXISTS BECAUSE I DO NOT KNOW WHAT WE WOULD DO WITHOUT IT.

I'VE READ COMMENTS THAT IT IS THE SAME THING. I AM SURE IT IS NOT.

Kara Hadley said...

I've had asthma for 17 years. For the first bunch of years I was in and out of the hospital and receiving nebulizer treatments several times a day. For the past seven or eight years I've only been using my meds when I had an occasional flare up (once or twice a year). I was on albuterol for a long time, but I've since been switched to xopenex. At first, xopenex was a miracle. With albuterol I usually had to be hospitalized and given sedatives. Xopenex was not like that, until this last attack. Once again, I have the racing heart and can't stop shaking.
Does anyone know of any alternatives to the two medicines that I could try?

Aimee said...

Kara - I don't know of any myself, but go to AANMA.org and "Ask a Nurse!" Follow this link: http://www.aanma.org/ask-a-nurse/

Good luck - and please share what you learn. I'm sure there are others who could benefit from the info.

Aimee

Anonymous said...

As a medical student, I was recently diagnosed with adult onset asthma, and during this process they used an albuterol nebulizer on me on a few occasions. Each time I had serious nervousness, the jitters, and such a bad intention tremor that I wasnt able to pick up the correct coins in my wallet. It was so bad was afraid the clerk probably thought I was using ilicit drugs! On the way home from the doctors office, I thought I was going to get into a car accident because I was so hyper aware of everything around me, I couldn't focus on driving the 5 miles to my house. When they decided to put me on a medication, I begged them with tears in my eyes to do everything they could to help me without the albuterol because I was afraid of how it would impact my medical career. They gave me a Xenopex HFA inhaler and I've not had any side effects, except if I use it too close to bed time I have a hard time falling asleep. (I have a hard time sleeping anyways... med school = too much stress!) We haven't really gotten to pulmonary pathology or pharmacology yet, but if I learn anything substantial, I'll let you know!

Aimee said...

Great comment, thank you! Please keep me in the loop when you get to pharmacology!

Anonymous said...

I have suffered from asthma and COPD for the last number of years and have used Albuterol regularly. At a recent trip to the ER I was given a nebulizer treatment. Although I assumed I was given Albuterol, I felt VERY different. I was not as gittery and also had clearer breathing.
I told the doctor this and he informed me that I was taking Xopenex--not Albuterol. It sounds like many people commenting on this site have had similar experiences.

My comment to people who say that Xopenex is the basically the same thing as Albuterol but given in lower dosages (and therefore has less gittery side effects).... If I can get the relief I need from Xopenex in a lower dosage with less side effects, then why not use it!

From years of first hand experience...I find Xopenex gives me relief for a few hours without as much gitteryness. What we should be working on is finding out a way to make Xopenex more affordable for people rather than trying to get if off the market. If that happened people with breathing difficulties would be at a loss.

sammscott said...

Im gonna weigh in as well as a mama who's child has used both the albuterol and xopenex in her neb. I know that all the available evidence says they are both equally effective and i believe thats true. However, our experience has been the same as many others, albuterol tended to be dosed in a higher concentration and the side effects afterward were *murder* on mommy. The xopenex, and maybe it is just the lower dosage, but it works as well at getting her breathing again and she isnt a hummingbird bouncing off the walls after. It (along with her advair instead of flovent) has worked SO well for her without as many nasty side effects, theyve been a godsend in our house!

Aimee said...

...and of course, nothing beats the albuterol/Orapred combination... The WORST!!

sammscott said...

ooh yeah no. albuterol plus the oral steroids is just plain..a nightmare

Anonymous said...

I have had severe asthma since childhood, and as an adult it has been important for me to learn to manage my asthma and other illnesses without drugs- I can say from personal experience and stories from a mother with a small child that diet change will almost make asthma disappear! I want to spread the news because it is the cheapest, healthiest option to control asthma and dramatically reduces the need for xoponex or albuterol! I was using rescue inhaler 3 times a day now down to 3 times a week.

The whole foods diet- you can google it but this is basically what we did
NO sugar (moderate/small amts of honey, maple syrup, agave nectar, etc.
NO white flour ever- whole wheat sometimes, lots of sprouted grain, whole grains
LOTS of leafy greens, beans
and just enough of the right fruits-
(This means no packaged foods and candy of course)

It takes a minute to adjust your schedule to have whole home prepared foods, but it is so simple once you get the hang of it. Be prepared to keep food on hand in the car. Homemade granola bars are a life saver. And there is plenty of food to eat that tastes good. seriously.

This works better than any inhaler. Doctors mask symptoms, with time and effort you can absolutely cure asthma without drugs. They will tell you this is not true, but you can find out for yourself and see results in just a few weeks of going hardcore on your food.

Anonymous said...

Without getting tanled into the Xopenex v Albuterol debate web ...

I buy my COPD meds online. At first I bought from Canada. Being cautious, I checked to see who made them. Cipla. I googled this name and learned they were one of the world's largest manufacturer of pharma's, located in India.

I then figured if Canadian pharmacies buy many of their meds from India, there must be an online pharmacy located in India.

There was.

I've been buying my monthly meds (that cost $400/mo. at Costco, and $270/mo. in Canada) from them for over a year now.

Here's a quick cost comparison between Albuterol and Xopenex from this place.

Albuterol 200mdi HFA 100mcg $3.50
http://alldaychemist.com/37_Albuterol

Xopenex 200mdi 50mcg $4.75
http://alldaychemist.com/878_Xopenex

Shipping is "outrageous", a flat rate $25. Simple solution: order 10 at a time.

A few days ago I received an order for 10 abuterol inhalers, total cost, $6.00 each. Xopenex would have been $7.25 each.

If Public Citizen/WorstPills.org's only complaint is cost ...

FWIW, I also must use:

Advair 25/250 120mdi $12.80
(for me, this is a ONE MONTH supply, I need 50/500)
https://alldaychemist.com/1296_Advair-Autohaler

Spriva 9mcg 120mdi $11.59
(two month supply, 18mcg is normal dose)

Customer service was very responsive the one time I needed them. They have a US phone number. The delivery time has been as short as 6 days and as long as 12 days.

Anonymous said...

PS: I just noticed that All Day Chemist's Xopenex 120mdi inhaler:
https://alldaychemist.com/878_Xopenex

has 50mcg per dose.

I suspect, but DO NOT KNOW, that this must be a typo. I can't imagine 25 inhalations to receive the 1.25mg recommended dose.

Their web site has a US phone number, for those who are interested.

Anonymous said...

PPS: I just looked it up. The mdi metered dose for Xopenex is 90mcg.

Nikki and David Goldbeck said...

I have just posted about Medicare taking away my Xop, when I noticed an interest in the wholefoods diet. I am the coauthor with Nikki Goldbeck (a nutritionist)of a number of books on the wholefoods diet and cuisine. You can read about them on HealthyHighways.com; our cookbook "American Wholefoods Cuisine"n uses no flesh, processed grains or sweeteners. It's been in print for 27 years. Check out the user's comments on amazon. I hope this post is approved - these books will help people.

Anonymous said...

concerned mom

my eight year old has been diagnosed with asthma and began taking the albuterol syrup..after a while she became very sad and says she want to cry all the time...Before taking the meds she was a loud playful young girl now she seems so attached to me and wants to cry all the time!!

Help please

Barrish said...

I am an adult and have used both Albuterol and Xopanex. (.63 mg) inhalation solution in my nebulizer.

With the Albuterol inhaler, I used to get all the known side effects: jitteryness, tachycardia, etc. With the solution (note: I have not used the Xopanex HFA inhaler)but with the Xopanex solution in the nebulizer, I have never had the side effects associated with Albuterol.

I use Max Air Auto haler with not too many side effects, except a weird sensation in my throat, most probably because of the propellant.

I LOVE XOPANEX. Its been a God-Send and to me it is worth paying the price for. Of-course, I wish it were less expensive.

Anonymous said...

I am a 30 yr.old woman with asthma. My doctor prescribed me Xopenex because I was avoiding using my albuterol inhaler due to my extreme nervousness and jittery side effects. Xopenex works. Maybe they should be prescribing albuterol in lower more manageable doses but until they do I will only take Xopenex. I have insurance so the cost is inconsequential to me. It blows my mind though when people disbelieve that regular albuterol actually has more intense side effects like these women don't notice the actual impact on their children or people who have personal experience are the result of big pharma. Don't get me wrong I am against big pharma but xopenex is the only thing I will take for my rescue inhaler.

Viola said...

I think one of the main differences between Xopenex and Abuterol is the additives. None of them are good, but Abuterol has the worst. I think that is what makes the difference for my son. He has fewer side effects from Xopenex, too. Viola

Rene Fabre said...

My 5 years old is jumping of the walls. He has been Taking Xopenex for 2 days , three times a day , administered by a nebulizer. He was coughing for a week and was prescribed this with Budesonide. I am concerned about his heart rate.

Anonymous said...

My 5 years old, 10 yrs old, and I have been using albuterol forever and I have no complaints. Yes, we get the increased heart rate but nothing else. I also care for a little girl who is on xopenex for neb and she also experiences jitters, increased heart rate, nausea, and whats worse is her asthma symptoms do not seem to improve until after her second dosing. She still suffers from shortness of breath and wheezing after neb tx is admininstered. Perhaps the severity of the asthma plays a role in that. Perhaps the lower concentration in the xopenex is not strong enough for her ashtma. All I know is that when my children or I are experiencing shortness of breath or wheezing, albuterol works quick fast and in a hurry. When the little girl I care for has the symptoms both I and her mother have to watch her like hawks knowing we cant administer another dose for 4 hours. Not all meds work the same way for everyone. Find what works best for you.

jcj3120 said...

I had this happen this morning. I took my albuterol in my neb and not only did it NOT help me breathe better it sent my heart racing! The ten blocks to the hospital felt likr an eternity. I couldnt concentrate. Was jittery. Then they gave me xenopax...the pressure in chest went away....i could breathe better...my heart rate didn't beat crazily n medicare covers it!

jcj3120 said...

I have asthma and an icky bout if bronchitis. Long story short....today after coughing spell i felt sob...chest pressure....so.i took albuterol in my neb. It didnt do amything for me except cause my heart beat to go up and i became very very jittery. Difficult driving to hospital. In ER they gave me a neb tteatment of xopenex. Instant relief. No racing heart. I will never take albuterol again and medicarr covered it. On the flip side...my five year old has no side effects from albuterol and he even has high blood pressure as a result of a congenital heart defect. In fact he took his dose less than an hour ago n he already out like a rock

Anonymous said...

I too have experienced the jitters and heart rate increase of albuterol, even after one puff. BUT at least I feel like I can breathe again after about ten minutes of anxiety and panic. I once had xopenex in a breathing treatment and it seemed to work with less side effects. BUT here is where it gets weird...I finally get a xopenex inhaler to take home and after I took the first puff my neck and lower back of my head went almost COMPLETELY numb, here I am sitting typing this 3 hours later and still feel numnbess and stiffness in my neck and back of head. and my breathing is NO better.

Aimee said...

Holy moly!! What did your doctor say??

Toni said...

Glad to see this site and the initial comment that sparked the thread (haven't had a chance to read all yet), but I've been using only Xopenex for my son, just turned 10, ever since the horrible side effects of albuterol were apparent at his first resp. distress when he was a baby.

Today, and the reason I just found this thread, is I'm back from a doctor in my pediatrician's group who has never seen my son (urgent care; our dr. was out and one of the reasons I took my chances was because I didn't want us in ER with albuterol) and had quite a tangle with her.

Anyway, once it was determined that she wanted him to have albuterol nebulizer treatment in office, I said no, reminding her of the conversation we had just minute before that he takes Xopenex (we had some with us, though dated). Yet she questioned it, in front of my son, saying there is no difference, and that she just wants him to get better... I explained again that we don't use albuterol because of side effects when he was younger was enough for me not to want again... she was insulting, condescending, saying it was the same. That if I just want to go to ER and get it there, then go, or we could get the treatment in the office... She went on to say, all the while my son not getting any treatment while she argued her point, that his heart would race a little faster like big deal but it would be ok and then she turned to him and started explaining the side effects. And then tells me, it's different now he's older... Once he started crying (I mean we're in a very small room and she's arguing with me about his care and he's a 10 year old who knows what he takes; she was scaring him), she agreed to put in the Xopenex I brought. I mean seriously?

Point: I'm glad there is an alternative, though it is so expensive.

Aimee said...

Honestly, is there anything worse than a) a doctor who is NOT up on the well-known side effects of common medications or b) a pediatrician who blatantly ignores the mother of his/her patient. GAH!