Warning Given on Use of 4 Popular Asthma Drugs, but Debate Remains

[Celebration]

http://www.nytimes.com/2008/12/06/health/policy/06allergy.html

WASHINGTON — Two federal drug officials have concluded that asthma sufferers risk death if they continue to use four hugely popular asthma drugs — Advair, Symbicort, Serevent and Foradil. But the officials’ views are not universally shared within the government.

The two officials, who work in the safety division of the Food and Drug Administration, wrote in an assessment on the agency’s Web site on Friday that asthma sufferers of all ages should no longer take the medicines. A third drug-safety official concluded that Advair and Symbicort could be used by adults but that all four drugs should no longer be used by people age 17 and under.

Dr. Badrul A. Chowdhury, director of the division of pulmonary and allergy products at the agency, cautioned in his own assessment that the risk of death associated with the drugs was small and that banning their use “would be an extreme approach” that could lead asthmatics to rely on other risky medications.

Once unheard of, public disagreements among agency experts have occurred on occasion in recent years. The agency is convening a committee of experts on Wednesday and Thursday to sort out the disagreement, which has divided not only the F.D.A. but also clinicians and experts for more than a decade.

Sudden deaths among asthmatics still clutching their inhalers have fed the debate. But trying to determine whether the deaths were caused by patients’ breathing problems or the inhalers has proved difficult.

[SharonRB]

1. I take Advair and took Serevent before Advair was available

Both have been lifesavers for me. I used to need a rescue inhaler all the time and now I almost never need it. Before Serevent came on the market, I made several trips to the hospital due to asthma attacks and my asthma was chronic and occasionally acute. One attack almost killed me. I was at a party and an ambulance had to be called because I couldn't breathe. That was the worst attack I ever had.

I sure hope they don't take them off the market.

[halobeam]

3. I'm sure that's exactly why these meds are out

but I still believe they didn't test them long enough. I mean look at the deaths of the young ones because of these drugs. Something needs improvement. You've been saved as well as others I'm sure, as well as some have died from it. That's messed up. I wouldn't want to take anti biotics that may either kill a major bacterial infection and save my life OR just plain out kill me.

[still_one]

4. There are potential side-effects with most prescription meds, and that is why

it has to be based a an individual basis. Different people react differently

I do not believe they will take them off the market, just have stricker labeling

For many drugs the side-effects can be quite severe, however they can literally be a lifesaver

[halobeam]

2. Too many new "magical" drugs w/o enough testing, imo

It's really not a conclusion I base on specific research, so if I'm off base, forgive me. Just seems, they already had so many meds that work and have been out way longer w/o such serious side effects (if you can even call death a side effect), so why make fifty other types?

My kids used Advair for three years at ages 6 and 10. They were switched off for ins. reasons, but thank god. Now they take Asthmacort and Asthmanex. I wonder when we will hear about those. These are fairly new, too, esp. Asthmacort.

[still_one]

5. It all depends. The side-effects from digoxin can be death, but not giving it would also mean death

[hedgehog]

6. I think part of the problem is trying to classify a range of symptoms under the umbrella of "asthma"

For example, asthma runs in my family, but none of us has ever had a sudden asthma attack. For us asthma manifests a gradual loss of lung capacity over several days due to inflammation, narrowing of bronchi and congestion. For us, proper treatment is home monitoring of lung capacity with a peak flow meter and the use of Advair when we start to show symptoms.

It's unclear to me whether the problem is with the newer medicines or with how the medicines are used by the patient. Maybe some people on Advair should be using it daily to keep the level of reactivity down so they don't have a sudden attack. Maybe some people will have sudden attacks regardless of their treatment protocol. I don't know.

[mopinko]

7. clutching their inhalers?

correct me if i am wrong, but the drugs we are talking about here are preventative, and not intended for, or good for, treating an active asthma attack. have a little yellow journalism here?

i am on my way to the doc today to talk about my fairly sudden uptick in my asthma. she already told me, tho, that she does not prescribe these drugs. she told me that the real trouble was the the worse the asthma, the higher the risk. so while they might be appropriate to keep a mild case of asthma at bay, they are dangerous for those who have it bad. so what is the point? i can easily see how it was difficult to tease out an effect like that, tho. complicated.