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

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By: Staff Writers | Published: April 19th, 2011

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.

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.

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There Are 7 Comments So Far • (Add Your Comments)

  1. 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.

  2. 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

  3. 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

  4. 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.

  5. 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.

  6. 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.

  7. 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!

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