Studies Ordered for Side Effects of Symbicort, Advair Diskus, Dulera, Foradil

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Federal drug regulators have ordered that new studies be done to examine potential safety problems with a number of asthma drugs, including Advair, Symbicort, Dulera and Foradil. 

The FDA announced it was requiring the new clinical safety trials on April 15 in an FDA drug safety communication.

All of the asthma drugs belong to a class of medications known as long-acting beta-agonists (LABAs). The FDA is concerned that the side effects of the drugs may increase the risk of severe asthma problems and death.

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Four of the ordered clinical trials will be for 11,700 patients 12 years of age and older and cover each of the four drugs; Advair, Dulera, Foradil and Symbicort. There will be a fifth clinical trial, again for Advair, involving patients ages 4 to 11 years old that will include 6,200 patients.

In all of the trials, the patients will be observed while undergoing treatment for six months. In the older subjects, researchers will compare the rate of serious asthma side effects, such as intubation, hospitalization and death. The pediatric trial will also look at issues that affect the children’s quality of life, such as missed days of school and emergency room visits. The FDA hopes to have results by 2017.

The trials will compare the safety of using LABAs in combination with traditional corticosteroid asthma treatments, as compared to the use of just corticosteroids alone. In February 2010, the FDA declared that LABAs should be contraindicated for use as a stand-alone asthma treatment.

That decision came after a review of previous studies that found that some LABAs can mask worsening inflammation in the airways, leading to worsening symptoms that may not be recognized in a timely manner. This could result in severe injury or death.

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, Asthma Drug, Dulera, Foradil, Inhaler, Symbicort
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21 Comments

Tony
I had mild asthma and later COPD. One year I had to sleep in a recliner for six months due to inability to breath in a supine position. Finally, I got relief from Advair Diskus after switching many different inhalers. Early on I started have severe muscle cramps in all areas of my body. Doctor visits gave no relief. Finally, a light bulb appeared over my head, I remembered my mother suffered with the same frequent severe cramps and she used Advair Diskus too. After discussing with my family doctor, we decreased the dosage and frequency lower and lower. This decreased the frequency but spasms continued. I stopped using Advair completely but still have the spasms at intermittent intervals. I believe I have a permanent disability now! I am interested in being involved in a class action suit if anyone can point me in that direction?
Jennifee
I’ve been on symbicort for only 2 days at 2 puffs 2x per day and already having tightness in my chest and I can no longer take in a deep breath with out some pain and strugggle. Now, I wasn’t diagnosed with asthma or copd but I have Alpha-1.
Tara
I had been using dulera also and now I’m having to have 7 crowns not counting the ones I had a few months ago 6 months after I started using this inhaler is this a side affect ,,I’m to the point I think I should just pull them all
Debbie
I used Dulera for 2 weeks and now my speech is slurred and no one can understand me.
Jody
I left a post Oct. 1, 2016. The Dulera is destoying my teeth now. I gargle after each use as well as brush my teeth. I’ve had more problems with my teeth than I have had my whole life.
Jody
The Doctor’s treat me like i’ve lost my mind and I almost started believing it myself. I’ve been using Dulara for several month’s now and i slur my speech, have a hard time walking, have balance problems and my teeth are highly sensative. Don’t take this the wrong way, I wouldn’t wish this on anybody but, you have just confirmed what I alway’s suspected. I was told by my neurologist told me the damage to my nerve’s is permanent.
Cambria
After using Dulera for only one month, (after being exposed to a cancer-causing insulation material in my house heating ducts, called ‘InsulSafe’) I had weakness in my legs and swelling,emotional changes ie; anger outbursts, and a skin rash on my chest and back. It has been three years since then, and I still have the rash, but now on my face too. It is red bumps that are at times like a pimple, but turns into a scab that peels off. And also peeling dry circled patches. My back has them also. They are ruining my complexion as now I have broken blood vessels on my cheeks and my skin is overall getting damaged and looks aged. My skin was great before I took the Dulera for a month. My lungs got better that month, but my health has not been the same since.
Karen
I was mis-diagnoised with COPD, when I only had bronchitis and asthma. I was prescribed Dulera which I remained on for 5 years. It almost killed me. It caused the worst infection the doctor had ever seen. It took over a year for my adrenal system to begin to work properly. It was awful. These are bad drugs. There should be a crime against giving them to children. Funny thing, over the years I was on it, it masked my infection. It made me a walking dead person in them. Thank God a gluten-free, soy-free & dairy-free diet alleviated my asthma. Asthma was a symptom of my allergy. For the first year I also stopped eating meat after reading a Dr. Weil article.
Denise
I developed asthma 2 1/2 years ago because of the job I work (I deliver to auto body shops) Asthma was cause by the chemicals i have to be around daily. Started taking Pro-Air and all was OK. Dr. said my symptoms needed to be better managed , so she gave me Flovent to use with it. Then – E.R. trip #1. Was told it sometimes takes a while for your system to adjust , and to give it a little more time. I did so. Then- E.R. trip #2. Long story short , Since this began , I have been to the E.R. 7 times. The last time was because of Symbicort. Almost went into cardiac arrest because of that crap – not to mention the horrendous side effects. I could not taste or smell anything , there was muscle and joint PAIN , itchy watery eyes , blurred vision , foggy thinking and the Pro -Air was no longer working like it used to. Symbicort is by far the most dangerous thing I have ever taken for this condition. I am currently on Pro-Air and prednisone. I know prednisone is supposed to be bad – but I’ve never had side effects with it , the way I have with the steroid inhalers. Until I can figure out some kind of natural solution – I’ll have to take my chances with the prednisone.
Diana
Symbicort caused chest pains after one month of use. Two puffs twice a day. It helped my breathing however when I stopped because of the chest pains, I was not informed that you can not stop cold turkery. I could not breath without it. I saved myself with Pro Air to keep my airways open. Every hour on the hour. After I stopped taking Symbicort, I had severe breathing problems. Only having slight discomfort with asthma before trying it. I have spent two and one half years trying to recover. I became allergic to many food items and had allergic symptoms to my environment. I lost 30 lbs in five months. I discovered I could eat some organic foods and began maintaining my weight loss. I had several severe bouts of not being able to breathe, but refused to us steroid inhalers again. Ended up using prednisone, which I found out is even more dangerous with the side effects destroying my teeth and bones. I am down to 2 mg of prednisone after one year and a half of usage. I have been here before,last year, but went into an exasperation which almost killed me. I became desperate when I could not breath on Pro Air alone, so resorted to 1/4 of the dose of Symbicort to help me get off of prednisone. So far, no chest pains. I will see if I can get off the remaining 2 mg of prednisone with this low dose of Symbicort. Then hopefully can totally wean from the Symbicort. I believe my original problem came from taking a Flu shot, shortly after starting Symbicort. My lungs seem OK. Any ideas?
Jamie
Husband died EXACTLY 1 1/2 weeks after starting SYMBICORT of cardiac arrest. Doc tried telling me that he had high blood pressure and high cholesterol that contributed to it. I DO NOT believe this. He was a very active 60 year old!
Gloria
Since using Dulera my asthma is under control but my teeth are quickly getting what seems like several cavities and are severely sensitive. I’ve also noticed my vision change for the worst how can the FDA allow this…. now what do I do can these changes be correctedor will they continue to worsen….
Diane
My brother used Symbicort and he had perfect eyesight and owned his own business, now he is legally blind and has lost his business and had to file bankruptcy and living on disability. It takes most of his check to pay the bankruptcy every month and he has no insurance to have his eyes fixed.
Holly
I was put on Dulera at end of Jan., 2014. Within 3 months cataracts had impaired my vision by May that resulted in needing surgery in both eyes. Had eye exam in Nov.,2013 had no cataracts. Three months of use gave me cateracts.
amy
Diane, did you always rinse your mouth out after taking Dulera? I have horrible asthma and just switched from Flovent to Dulera. It seems to work a lot better but I\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\’m worried about the side effects. How can it mask symptoms of asthma? I think I would be able to tell of I couldn\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\’t breathe. All this talk about side effects makes me want to go back to flovent!
Jane
My teeth have quite literally dissolved since I started using Dulera. I am now at the point where I will either have to have full dentures or implants.
mary
My Dr. put me on advair and the next day I could breathe put I could barely walk without being short-of-breath. I could not use the stairs at work and could hardly walk down the hall. I saw the cardiologist and he told me I needed to have an angiogram because the stress test I had taken showed something wrong with my heart. Well, of course,it would because I could no longer walk, and therefore flunked the stress test. I told the cardiologist that it was the advair and he and the pulmonologist said no that the advair would not do this. I went through the danger of an angiogram because two drs would not believe that advair did this to me and they were one hundred percent wrong. I stopped taking advair on my own and I could once again walk and use the stairs. Also, the angiogram showed no heart problem.
ron
My grandfather at age 74, was in perfect health and no problems. Test before death by mri and cat scan came up clean 7 weeks of using symbicort was found dead with blood from mouth, nose and ears. Slurred speech and other symptoms arose before death.
Rhoda
Symbacort has caused my husband’s teeth to literally rot inside his mouth. At 50, he had 0 cavities. At 54, he only had 2 teeth in his mouth that are good. 10 need extracting, other need root canals and crowns. This is something that needs to be addressed
Carol
My daughter, Angela Hamil age 40 had a reaction to Advair, it caused her to have slurred speech. She stopped using it and was put on Dulera by her respiratory doctor. After using it for a month or so, she started having slurred speech again, then progressed to drop foot, and now to seizures in the right side of her face and ficiculation in her tongue. Now she is seeing a neurologist in Dallas to see if she has MS or ALS. It has been three months since onset and no diagnosis. The doctors say they don’t think it has anything to do with Dulera, but I want to know if other asthmatic patients have developed these diseases? Angela was in good health and was holding an office job, she only had asthma, but now she has to use a walker, wear a brace on her left foot, and her slurred speech has made her not able to be underrstood. Concerned Mother
Mitch
Symbicort caused me to suffer a respiratory arrest, followed by my heart stopping. Had I not collapsed out in my yard, and a passerby called 911, I would be dead. I was in a coma for 3 days. I am very lucky that junk didn’t kill me.

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