Tuesday, August 17, 2010

Asthma Drugs, Advair, Symbicort, Safety Claims Questioned

Asthma Drug's
Advair,Safety Claims Questioned
: "In the current study, Dr. David M. Lang of the Cleveland Clinic Foundation in Ohio and fellow investigators looked at data on asthma hospitalizations in Philadelphia from 1995 to 1999 and prescription rates for long-acting beta agonists and other asthma drugs.

In 1997, guidelines were released that recommended adding long-acting beta agonists, such as salmeterol (Serevent) and formoterol (Foradil), to low-dose inhaled corticosteroids for patients whose asthma wasn't adequately controlled with the steroids.

Since then, however, several studies have linked long-acting beta agonists, LABA to increased risks of severe asthma attacks, asthma hospitalizations, and even death.

The drugs are likely harmful, agreed Dr. Shelley Salpeter of Stanford University in California. She pointed out that both long-acting and short-acting beta agonists can cause the user to develop tolerance to the drug, which leads to worse reactions to asthma triggers.

"It is clear" from her 2006 analysis of clinical trials, as well as other studies since then, that such drugs are linked with increases in asthma hospitalizations, life-threatening exacerbations, and even deaths from asthma, Dr. Salpeter continued.

The real debate, Drs. Salpeter and Cates commented, is not whether long-acting beta agonists are risky. Today's controversy revolves around whether combining them with inhaled corticosteroids eliminates their risk. Recent data suggest that the combination is still more dangerous than corticosteroids alone.

The study by Dr. Lang and his colleagues was funded by an unrestricted grant from GlaxoSmithKline, which manufactures formulations of salmeterol alone and combined with inhaled corticosteroids. The report states that the company was not involved in designing the study, interpreting the data, or writing the manuscript.
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Bills Comments: Note also that the company's top selling drug is the asthma medication Advair, a combination of two other company products, Flovent a fast acting bronchodilator and Serevent a LABA.

Symbicort, another combination of a slow acting and fast acting agonist, is made by Astra Zenica and presumably since both drugs are in the same class, the above findings apply equally to both. Warning of Symbicort label: WARNING: Long-acting beta2-adrenergic agonists (LABA), such as formoterol, one of the active ingredients in SYMBICORT, increase the risk of asthma-related death. A placebo-controlled study with another LABA (salmeterol) showed an increase in asthma-related deaths in patients receiving salmeterol. This finding with salmeterol is considered a class effect of LABA, including formoterol. Available data from controlled clinical trials suggest that LABA increase the risk of asthma-related hospitalization in pediatric and adolescent patients
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