Risk of Problems from Asthma Drugs Lead to New FDA Warnings

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Federal regulators have moved to restrict the use of Advair, Symbicort, Foradil and Serevent, after determining that side effects of the asthma drugs may increase the risk of severe asthma problems and death in both adults and children.

On February 18, the FDA indicated that Advair, Symbicort, Foradil and Serevent should never be used alone in the treatment of asthma in children and adults. The agency is contraindicating the drugs for solo use and requiring manufacturers to create risk management strategies to educate and train health care professionals and patients about the risks of using the drugs for long-term asthma treatment.

The decision comes after an FDA analysis of a number of studies on the drugs, which are known as long-acting beta agonists (LABAs). The review was undertaken after studies raised concerns that long-term use of LABAs could cause a worsening of asthma symptoms and death in some users. Foradil, Severent, Symbicort and Advair side effects can mask worsening inflammation in the airways, the FDA determined, and worsening asthma symptoms may not be recognized in a timely manner, potentially leading to severe health risks and death.

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Advair (salmeterol and fluticasone) and Serevent (salmeterol) are manufactured by GlaxoSmithKline PLC. Foradil (formoterol) is made by Novartis AG and marketed in the U.S. by Schering-Plough Corp. Symbicort is manufactured by AstraZeneca. Advair is the biggest seller out of the four drugs, with sales of nearly $7 billion annually.

In December 2008, an FDA advisory panel recommended a Foradil and Serevent should no longer be approved for asthma treatment. However the panel did not make the same recommendations for Advair and Symbicort, because the drugs are combination products that include a corticosteroid medication.

The FDA decision on Thursday means that the labels of all four drugs will state that LABAs are contraindicated without the use of an asthma controller medication, like an inhaled corticosteroid. The drugs will also include label warnings indicating that they should be used for the shortest duration possible and then discontinued, and that they should only be considered for long-term asthma treatment by patients whose asthma cannot be adequately controlled by other medications.

In addition to the label changes, the manufacturers will be required to create a risk management strategy (REMS) outlining a plan to minimize the health risks to patients. The companies will have to make a revised medication guide for patients and will have to create education plans to ensure that health care professionals are well-informed about the appropriate use of LABAs.

“The risks of hospitalization and poor outcomes are of particular concern for children,” said the FDA Office of Pediatric Therapeutics Director Dianne Murphy.” Parents need to know that their child should not be on a LABA alone.”

Asthma affects 20 million Americans, including 6.5 million children. It is a chronic disease with symptoms like wheezing, difficulty breathing and spasms, which can severely limit activities and impact quality of life.

Tags: Advair, Asthma, AstraZeneca, Foradil, GlaxoSmithKline, Novartis, Serevent, Symbicort
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9 Comments

vincent
In 2006 my sone Vincent Thomas jr died due to the use of advair. His mother sued glaxosmithkline and if any attorneys are viewing these comments I ask that you contact me. I wasn’t allowed to have nothing to do with this lawsuit and my name was forged for the settlement. I need help with this matter on reaching the company responsible.
Lisa
I am writing in reference to my mother whom this past Saturday I had to take off life support. She has had asthma for fifteen or more years. She first did a test that was performed by the Veterans Administration and had asthma , but was not told for years. We had only found out because she had a severe attack and had to be hospitalized. She was released and followed up with the VA and was placed on inhalers to control her asthma. Thru the years she occasionally would change medication. She did quite well and always used her medications. This past year a Nurse Practitioner changed her long acting inhaler to Symbicort .She was always tired and had more frequent asthma attacks.I told her she probably needed another breathing study done. it wasn’t until recently she was scheduled an X-ray of her lungs, in which she was unable to keep. She got a cold and developed double Pneumonia and ultimately passed away. It wasn’t until recently I really listened to the Symbicrt commercial that states it should not be used in asthma patients. I feel this inhaler contributed if not completely caused her death.
Elizabeth
I have been on advair for a couple of years and if I missed a dose I could not breathe at all! My asthma was never this bad until I started advair and cant breathe without it. Over the past two years I have had several procedures because of abdominal spasms and ended up having my gallbladder taken out thinking that would take care of it. I was still having the “attacks” as I call them. I started realizing I couldnt stretch my legs out without having severe spasms and the spasms in my abdomin would be so painful I would feel paralized. I have spent 3 years in misery doctor after doctor and never once thought It could be the advair, something that was helping me breathe but destroying the rest of my body at the same time. two weeks ago I decided on my own to quit taking advair and the spasms in my legs have gone away. I havent had a “attack” of my abdomen since. I have never felt better. less tired and feel like I could wean myself off my zoloft that I was put on for what I thought was pmdd but really believe it was the advair inhaler. I do have to use my breathing treatment twice a day now but I have never felt better and I hope noone has to experience the side effects I have.
Lynne
Question. What about my getting adrenal insufficiency from using advair. It is happening quit frequently. I have been sick for the last year. Will this be included?
Meri
I was on Advair for many years. If fact I was on the highest dosage I belive 50-500. If I missed a dose I would have a asthma attack and end up at the hospital. I became that dependent on it. Not only has my asthma been 50 times worse and caused me to overuse my albuterol (just to keep breathing) but I belive it has affected my heart (every emergency room visit EKG are abnormal), higher bloodpressure,hemateria (blood in the urine),bowel problems, severe acid reflex, along with many other symptoms that I never had before my doctor gave me those “free” samples and ever since then my health has been downhill. I have not used it for just under a year. I still have to use my albuteral all the time but my trips to the emergency room has been fewer (for asthma attacks) and my other symptoms are getting worse. I wonder if the corticosteroid can cause problems also. I was on Advair for a long long time.
Robert
My wife died quickly 2 mos ago from what appeared to be a stroke. She had been on Advir a couple of years with an increased dosage 50/250 this past year. low level Pnemonia a couple times a year, with the last quite severe. Advair helped the Asthma but if it contributed to her death because she was on it so long, I’ll never know. (She was 77) I miss her so.
P Fehling
My elderly mother was on Advair for 2 years for asthma. During that time she had severe pneumonia 3 different times. I have since found out that anyone with COPD has a 30% increased risk of getting pneumonia if using ADVAIR. I bet the increased risk is even greater for the elderly. After the 3rd bout of pneumonia, which almost killed her, I asked her pulmonologist about the Advair/pneumonia connection. He discounted it, saying it was a flawed study. ( It was not) I told him that I was not going to let her use this medication anymore. Since that time, 15 months ago, she has not had a cold, bronchitis or pneumonia. On top of that, her asthma is not any worse, maybe even better. Her cognitive state however has been severely affected by the 3, month long hospital stays for pneumonia. Advair is dangerous. If you are not doing well or getting respiratory infections, discuss the risks of Advair with your doctor.
Paula
My 18 year old son was recently diagnosed with cardiac arrythmia after a routine doctors visit. He had an Ekg and a heart scan. He has been using advair for a few years. He is a college athlete and has not been able to perform well this season as he has hoped. He will not be able to continue with swimming at a highly competitive level. He has found he is more out of breath recently and not from the asthma. I am taking him for a second opinion from a cardiologist
JERI
I USED ADVAIR OFF AND ON FOR OVER A YEAR MAYBE TWO. I WOULD STOP BECAUSE I WOULD GET THRUSH IN MY MOUTH AND THROAT. IN APRIL OF 2009 I HAD TO HAVE A BIOPSY OF MY THROAT WHICH DIDN’T SHOW CANCER BUT DID SHOW BAD CELLS. I HAD TO HAVE ANOTHER BIOPSY IN NOV 2009 BECAUSE I WAS BLEEDING FROM MY THROAT. I HAVE AN APPOINTMENT WITH MY THROAT DOCTOR APRIL 12 2010 AT WHICH TIME I WILL MOST LIKELY BE SCHEUDLED FOR MY NEXT BIOPSY. I AM ON SPRIVA NOW PLUS TWO OTHER INHALERS. THE FIRST TIME I WAS TOLD ABOUT THE BAD CELLS IN MY THROAT I HAVE WONDERED EVERY SINCE IF IT WAS CAUSED FROM THE INHALERS BECAUSE OF GETTING THE THRUSH SEVERELY TIMES IN MY MOUTH AND THROAT.

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