Serevent: Scientists Push for Recall, Advocates Claim Big Pharma Coverup

Portland, ORAccording to Cornell and Stanford University researchers, the asthma drugs Serevent, Advair and Foradil should be recalled due to health safety concerns. In light of these findings, consumer advocates are outraged that the drugs remain on the market, and question whether there has been a coverup by Big Pharma.

Asthma Deaths Linked to Drug
Researchers from Cornell and Stanford universities have published a study concluding that Serevent, Advair and Foradil may be causing four out of five U.S. asthma-related deaths per year. The scientists believe that the medications promote bronchial inflammation and sensitivity without warning.

In an analysis of 19 published trials involving 33,826 patients, the research team found that users of Serevent, Advair and Foradil inhalers were 3.5 times more likely to die from asthma and 2.5 times more likely to be hospitalized compared with those taking a placebo.

Edwin Salpeter, a lead researcher from Cornell, said: "We can show that overall it is statistically significant that, compared to patients taking a placebo, these long-acting beta-agonists kill a lot of people."

Researchers: Take Serevent Off the Market
"These asthma deaths are generally in healthy young adults," said the papers co-author, a clinical professor of medicine at Stanford's School of Medicine. "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."

"We urge that [these drugs] be taken off the market," she added.

Another recent study by the National Jewish Medical and Research Center in Denver has found that Serevent may expose African-American patients to a higher risk of asthma-related death. According to researcher Dr. Harold S. Nelson: "The bottom line is that in a very large study ... there was an increased number of severe asthma attacks, including fatal attacks," among African-Americans using Serevent and Advair.

Black Box Warning
While Serevent remains on the market, last spring, the FDA began requiring updated versions of the "black-box" warnings on Serevent, stating that salmeterol, the active ingredient in Serevent, may increase the risk of asthma-related death.
According to the FDA's warning, Serevent "may increase the chance of severe asthma episodes, and death when those episodes occur."
Black-box warnings are the most severe warnings the FDA can require of prescription drugs. But is it enough?

Public Citizen: " Recklessness" at FDA
Consumer advocacy group Public Citizen has accused Serevent's maker, GlaxoSmithKline, of giving misleading study results to the FDA. Public Citizen director Dr. Sidney M. Wolfe says GlaxoSmithKline misled the FDA years ago about the increased risk of Serevent asthma death. In fact, Wolfe asserts, the FDA complained about the delay in realizing the increased risk of asthma death existed.

According to Wolfe, GlaxoSmithKline's failure to fully disclose the drug's actual risks was "reckless and dangerous."

While the FDA acknowledges that some patients using Serevent might face life-threatening complications, for now the drugs remain on pharmacists' shelves.

If You Are Using Serevent
Physicians stress that patients currently using Serevent, Advair or Foradil should NOT stop using them without consulting their doctors. Stopping use medication without replacing it with another asthma medication under the supervision of a physician could be fatal. Meet with your doctor to discuss your options and course of treatment.

If you believe that either you or a loved one have experienced an adverse reaction to these drugs, you may wish to seek legal counsel in addition to medical advisement.