FDA Panel: Restrict Some Top Asthma Drugs

Experts Say Risks Of Using Foradil, Serevent Outweigh Benefits; Advair OK

(CBS/AP)  Government health advisers Thursday called for restrictions on some long-acting asthma drugs, but spared Advair, a top-selling medication used by millions of patients.

Outside experts advising the Food and Drug Administration recommended that Foradil and Serevent no longer be used for asthma. But they said the benefits of Advair and Symbicort clearly outweigh the risks.

All the medications contain an ingredient, known as a long acting bronchodilator, that relaxes muscles around stressed airways, reports CBS News Medical Correspondent Dr. Jon LaPook. But that may mask symptoms that can trigger life-threatening asthma attacks.

Advair and Symbicort contain a second ingredient, a steroid, that reduces inflammation inside breathing passages and may help patients avoid such problems.

Serevent and Foradil do not, and experts fear that they may they may cause patients to overdose or delay treatment.

"The concern for these drugs is that they may actually worsen asthma," Dr. John Jenkins, director of the FDA's Office of New Drugs told LaPook. "Rarely, in some patients, to the point some patients have died."

The FDA's own drug safety experts had recommended restrictions on all four drugs, including that none of them be used to treat asthmatic children. But the agency's respiratory specialists said the risks were manageable and no curbs were needed.

With its own experts deadlocked, the FDA called in an unusually large panel of 27 outside advisers. The medical and scientific experts said Advair and Symbicort should continue to be used with all patients, including children. The vote on Advair was 27-0; on Symbicort it was 26-0. On Foradil nine voted "yes" and 18 said "no," with a "no" vote meaning the risks were greater than the benefits. For Serevent the vote was 10-17.

The FDA usually follows the recommendations of its outside experts.

About 22 million people in the United States suffer from asthma, which claims nearly 3,600 lives. Children account for nearly one out of every three patients. An FDA analysis showed that the risks of long-acting asthma medications, though rare, were greater in children.

The four medications contain a kind of drug called a long-acting beta agonist, or LABA. It relaxes the muscles around stressed airways to help patients breathe.

But medical treatment guidelines say people with asthma should use a LABA together with a steroid to relieve inflammation within the airways. Advair and Symbicort combine both kinds of medicine in one inhaler. But Foradil and Symbicort are LABA-only medications.

In recent years, millions of asthma patients have turned to the long-acting drugs to help them breathe more normally, allowing adults to get nights of uninterrupted sleep, and kids, for instance, to join a soccer team. Advair dominates the market, with almost 4 million patients.

But in rare cases, the drugs can increase the risk of serious asthma complications and send patients to the emergency room gasping for air.

Some experts believe that using a LABA alone can mask developing symptoms, and unexpectedly get patients in trouble. That's why treatment guidelines call for LABA medications to be used with a steroid. Asthma patients also carry a "rescue" inhaler for emergencies.

The companies that make the medications say they are safe, and that at least some of the medical evidence that has raised questions is of poor quality. Doctors who treat asthma had urged the FDA advisers not to ban LABAs.

"If this drug is removed from asthma treatment it would be a disaster," said Dr. Stanley Szefler of National Jewish Health, a Denver health system with a national reputation for respiratory care. He spoke on behalf of the American Academy of Allergy, Asthma and Immunology. Other medical societies voiced similar sentiments.

Baltimore-area teacher Anne Dorsey came to the meeting with her son Julian, 13, who has severe asthma. The mother told the panel that Julian nearly died from an asthma attack in 2006. But he has done much better since then, after he started taking Advair.

"I've spent a lot of time in the hospital," Julian said. "But when I took Advair, life got a whole lot easier."

Julian will be able to continue taking Advair. Patients taking either Serevent or Foradil should talk to their doctors.

"I think it would be a big mistake for somebody who is currently on these medications to stop the medications without consulting their physician," Columbia University Medical Center's Dr. Meyer Kattan told LaPook.

In preparation for the meeting, the FDA analyzed findings from 110 clinical trials involving nearly 61,000 patients, comparing patients who took a medication containing a LABA with those who used a steroid alone to control their asthma. Experts looked for deaths, hospitalizations and cases in which a patient had to have a breathing tube inserted.

The analysis found 20 deaths from asthma complications, of which 16 were in patients taking a LABA-only drug, Serevent.

Advair, made by GlaxoSmithKline, did not appear to have a higher rate of serious complications when compared with treatment on steroids only. Foradil, Serevent and Symbicort all had higher rates of problems, but the increase was statistically significant only in the case of Serevent.

Serevent is also made by Glaxo. Foradil is made by Novartis and Symbicort by AstraZeneca. That company disputed the FDA's analysis of Symbicort, saying the agency only considered a small slice of available data.

[Ghostly1]

I was on Advair. I had suffered severe body cramps from Advair. I stopped taking Advair, when my entire body went into a cramp. I was home alone & couldn''t call for help.

If you start to take Advair & body cramps should start. Call your doctor at once & stop taking it.

[sscwwhite]

I hope all of you read this. Go to www.asthmastory.com and read about treating asthma with Zithromax -- 600 mg. taken three days in a row and then once weekly for 12 weeks and then possibly do another round of treatment. This works! Dr. David Hahn of Wisconsin is conducting studies all over the country now with this treatment. Go to the website and read the story and go to the links telling about this research. My son has had moderate asthma for 10 years and has been on this Zithromax therapy, two rounds now, and is so much better - he is off all asthma medication. No more Pulmicort. Serevent is very dangerous, and so is Singular - my son was sick from being on Singular. This medicine is terrible and it all just masks the symptoms of asthma. Please go to this website and share this with everyone you know. We are hoping our son is cured of asthma - asthma is an infection not a disease! I wish a journalist would do a nationwide story on this treatment! Doctors know about this, but they will not offer this treatment to you .... don''t you wonder why? $$$$ is our best guess at the risk of our child''s health.

[sscwwhite]

I hope all of you read this. Go to www.asthmastory.com and read about treating asthma with Zithromax -- 600 mg. taken three days in a row and then once weekly for 12 weeks and then possibly do another round of treatment. This works! Dr. David Hahn of Wisconsin is conducting studies all over the country now with this treatment. Go to the website and read the story and go to the links telling about this research. My son has had moderate asthma for 10 years and has been on this Zithromax therapy, two rounds now, and is so much better - he is off all asthma medication. No more Pulmicort. Serevent is very dangerous, and so is Singular - my son was sick from being on Singular. This medicine is terrible and it all just masks the symptoms of asthma. Please go to this website and share this with everyone you know. We are hoping our son is cured of asthma - asthma is an infection not a disease! I wish a journalist would do a nationwide story on this treatment! Doctors know about this, but they will not offer this treatment to you .... don''t you wonder why? $$$$ is our best guess at the risk of our child''s health.

[bab14000]

I have used Serevent and Singulair for years with great relief for my moderate asthma. I used to use Advair in place of Serevent, but began developing oral thrush infections (even following the rinse mouth instructions). Within a week of use of steroid containing inhalers I develop a thrush infection. So for me the Serevent and Singulair have been my best options. Serevent, like Advair comes with a counter, so you can tell if you have missed a dose or not. I always error on the side of missing a dose rather than inadvertently taking an extra dose. The use of these and many other medications should be up to a patient and their doctor with the discussion of use and risk/benefits.

[luckybreath]

I was dignosed with Muliple Chemical Sensitivity thanks to being exposed to "alleged" illegal H2S releases by the oil/gas industry. My doctor gave me Advair last week. I took it and within hours I had severe muscle cramps and pain. I could not move, I felt paralyzed. My husband called an ambulance. I will never take a "medicine" again with researching the ingredients! Anyone can contact me at [e-mail] with their stories as I am compiling an article on this horrible experience.

[sharonmac1]

I have been a severe asthmatic for over 30 years. I used to be hospitalized at least twice a year for about 20 years. I have tried allergy shots, have very little carpet in my house, have the mattress and pillow covers. I remember when a trip to the er meant getting a shot of epinephrine. I remember taking medications like Quibron and Theodore. These medications were terrible. Not a bad as prednisone though, which a would have to take several times a year. I had to take prednison so often that I now have cataracts, decreased bone density, and my teeth chip and or break often. Thank God for good dental work. Advair and Singular saved my life. Literally. I have not been to the er and have not been admitted to the hospital in over three years. Every medication has side effects. Some worse than others. For me the benefits far out weigh the risks.
Has Dr. Hahn also warned you of the over use of antibiotics. Axithromax is a medication also given to HIV and AIDS patients to help them fight off infections due to their compromised immune system. Any asthmatic realizes that a cold, virus, flu, etc. can cause their asthma to flair up. When this happens an antibiotic may be necessary, but asthma is a disease and should be treated accordingly. The fact that you are not allowing your child to be treated accordingly is a huge injustice. Asthma needs to be treated properly so the lungs are not damaged any more that they already are.

[sscwwhite]

You are ignorant if you refuse to do the research and see that your asthma was probably started by an infection years ago, and the bacteria colonized and continued to grow until the inflammation was so great that it started to affect your airways. Dr. Hahn has been studyijg this for years, and there has been much research done. Do some reading on Chlamydia pneumoniae bacteria - go to http://www.asthmastory.com/cp.asp and read some of this information and then read about the national clinical trials that are ongoing treating asthma with Zithromax. Also go to http://www.drmirkin.com/morehealth/9378.html and read what Dr. Mirkin has to say - he is a graduate of Harvard University and Baylor University College of Medicine. He is one of a very few doctors board-certified in four specialties: Sports Medicine, Allergy and Immunology, Pediatrics and Pediatric Immunology. Click some of the links on his website to read more about asthma. My son was first treated with Biaxin, and then switched to Zithromax at the recommendation of Dr. Hahn since it gets inside the bacteria cell. You know what prednisone and steroids have done to you so you should be willing to research and take a simple antibiotic and you will see the dramatic difference in how you feel. My son took two rounds of Zithromax .... about 24 weeks in total.

[sscwwhite]

Oh and one more thing Sharon, if you do read about this bacteria, you will see that they are tying it to heart disease, rheumatoid arthritis, possibly multiple sclerosis, and many other health issues. Simply google the bacteria and you will be amazed at the information that is available. Try reading this link: http://www.rain-tree.com/myco.htm -- it is an easy to understand article describing this bacteria and then you will understand how this can be tied into asthma and other health issues. This is really very interesting. Also, when my son took the Biaxin and Zithromax, he had no problem with those antibiotics. He did take probiotics daily to ensure he had no intestinal problems from the antibiotics. Taking antibiotics was a simple decision when you have seen your son have asthma attacks that were life threatening.