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Advair, Serevent, and Foradil: Is the Promise of Breathing Easier Worth the Potentially Deadly Risk Posed By These Asthma Drugs?

Oct 1, 2006

When labels continue to have changes, especially significant (and ever more serious) changes listing severe (and even potentially fatal) side effects, that should be a warning to medical professionals and patients to start being extremely cautious about prescribing and taking these medications.  

When “black-box” warnings are added, the drug should immediately become a last resort.  Pharmaceutical companies will still try to market and sell the drug regardless of the new, severe warnings so it is the responsibility of doctors and other medical professionals to explain the severity of the warning to patients before suggesting or prescribing the treatment.   

Just one month later, the three drugs were in the news again, and the news was not good.

A new analysis of 19 clinical studies found that Advair and Serevent pose a significantly increased risk of hospitalization and death to users compared with placebos.

The discovery of this new information, published in the journal Annals of Internal Medicine, has led a number of experts and consumer watchdog groups to call for the drugs to be removed from the market. The authors point out that “black box” warnings have not reduced the number of prescriptions for drugs like Advair and Serevent thereby suggesting that additional protection of the public is needed including the possible removal of certain drugs from the market altogether.
It is estimated that more than 3.5 million patients use Advair and it is one of GSK’s biggest sellers. In the new analysis, it was estimated that Advair "may be responsible" for as many as 4,000 of the 5,000 asthma-related deaths each year in the United States alone.

Researchers at Cornell and Stanford Universities are now arguing that Advair, Serevent, and Foradil should be taken off the market, citing that they are responsible for causing four out of five asthma-related deaths per year in the United States. This statistic is mind-boggling since the drugs are intended to produce precisely the opposite result.

"We estimate that approximately 4,000 out of the 5,000 asthma deaths that occur in the U.S. each year are actually caused by these long-acting beta-agonists, and we urge that these agents be taken off the market," said Shelley Salpeter, the lead author of the paper appearing online and in the June 20 issue of Annals of Internal Medicine. Since many of the deaths in the Cornell study involved healthy young adults, there is good reason to be concerned about this particular type of asthma medication.

Of the 19 studies surveyed in the meta-analysis, the largest was the Salmeterol Multicenter Asthma Research Trial with 26,000 participants.  This study found a 400% increased risk for asthma-related deaths and a 200% increase in life-threatening asthma events in patients using salmeterol. Yet, if older people, who also suffered from chronic obstructive pulmonary disease, were taken out of the equation salmeterol would be associated with a 600% greater risk for asthma-related death.

The meta-analysis also found that 53 of 3,083 patients inhaling beta-agonists were hospitalized for an asthma attack compared with 12 of 2,008 patients who received a placebo.  This indicates that there was one hospitalization for every 58 (1.7%) patients treated with a long-acting beta-agonist per year.

The information about Advair, Serevent, and Foradil seems only seems to be getting worse as time goes on. For some asthma patients, however, theses drugs are life-savers. Thus, the decision to pull them from the market is not a simple one. If some people are surviving only because of these drugs, it would seem harsh, to say the least, to deny such patients access to them. Of course, leaving the drugs on the market exposes a large number of other patients to significant risk and ignores the possibility that they may be treated successfully with older and safer alternative medications.

The most recent gathering of information from the 19 studies does serve to show, however, that even in life-threatening situations; these three drugs may do more harm than good.

It remains to be seen whether the FDA will take further action to either revise the labels once again or remove the drugs from the market if information about more negative effects surfaces.  
While asthma is a common condition, there are still only a handful of treatments available for both adults and children. Therefore, it is important to figure out which treatment is right for you and it may not be the same drug that your friends, spouse, or children are using.  Each person reacts differently to a prescription drug and therefore it is important that patients pay attention to the data from clinical trials so that they can see how other individuals with their particular condition have responded to the treatment. Consumers should always discuss their medications with their doctor and even their pharmacist to gather as much information as possible.

If you or a loved one has suffered an injury that you suspect is associate with Advair, Serevent, Foradil, or any other prescription (or over-the-counter) medication, please contact the attorneys at Parker & Waichman at for a free consultation and analysis of your particular situation. 

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