Manufactured in 2000 by GlaxoSmithKline, Advair an inhaled medication, contains both Long-Acting Beta-Agonists, fluticasone propionate (Flovent) and salmeterol (Serevent).This combination treatment decreases inflammation in the lungs, and works to relax the muscles around the airways in the lungs. Advair is primarily used to treat asthma attacks and chronic pulmonary disease.
Salmeterol, an active ingredient in Advair raises the chance of a person having a life threatening asthma attack. The largest study done to understand the safety of salmeterol was the SMART study in 1996; thousands of patients with asthma were split into two groups and asked to pair their current asthma medications with Serevent or a Placebo inhaler. SMART an acronym for Salmeterol Multi-Center Asthma Research Trial, was stopped in 2002 due to some concerning results by scientist which included:
- Of the 13,179 people using the salmeterol drug, thirteen suffered fatal asthma attacks brought on by the medication itself. For comparison, three out of the 13,176 people taking placebos died during the SMART. The risk of suffering a fatal asthma attack from salmeterol drug use was found to be even greater in the African American population.
- Among African Americans the increased risk of asthma related death of those who had taken Salmeterol was five times greater than those to those given a Placebo
- Among patients with asthma not using an inhaled steroid as a preventive (controller) medication, again more deaths and near-deaths from asthma occurred in those given Serevent than in those given a Placebo.
Clinical results were applied to Advair because its main ingredient is Salmeterol. Injuries associated with those who have taken Advair include:
- An irregular heart rhythm
- Severe Asthma Attacks
Due to these and many other findings on the FDA decided to makes changes as to how Long-Acting Beta-Agonists should be used. In August of 2003 Black box warnings were placed on all drugs that contained salmeterol including Advair indicating the risk of suffering a fatal asthma while on this medication. February 2010 the FDA advised individuals not to use LABA’s any longer than needed to stabilize their asthma. In this same warning it urges that LABA’s are not be used alone but in conjunction with an asthma controller medication. The FDA is also requiring a Risk Management Program which will provide patients with a medication guide and doctors an educational guide on how to use LABA’s appropriately. Further the FDA has issued additional clinical tests to evaluate the use of LABA’s with inhaled corticosteroids.
The attorneys at Feldman and Pinto are dedicated to holding GlaxoSmithKline responsible for their misleading labels, and their failure to disclose life threatening side effects. If you or anyone you love has suffered any of the side effects mentioned above after taking Advair please contact one of our specialized pharmaceutical litigators immediately.