Drug Warning: Serevent
Manufactured and marketed by: GlaxoSmithKline
Purpose: For the treatment of asthma, which is a condition where inflammation of the airways causes airflow to and from the lungs to be restricted.
Side Effects Reported
- A large placebo-controlled safety study of Serevent referred to as Salmeterol Multi-center Asthma Research Trial (SMART) was started in July 1996, after the FDA received reports of several asthma deaths associated with the use of Serevent Inhalation Aerosol, and after studies raised concern about the regular use of short-acting and long-acting beta-agonists.
- In early 2003, GlaxoSmithKline announced that it was stopping the SMART study after an interim analysis revealed an increased risk of asthma-related deaths and life threatening episodes among patients given the drug (13 deaths out of 13,176 patients treated for 28 weeks versus, 3 of 13,179 for those on placebo).
Industry Report
After the results of the SMART study were released, the FDA required that a "black box" warning be placed on Serevent. Black box warnings are the strongest warnings available to the FDA, and are meant to give health care professionals a clear understanding of a potential medical complication associated with a drug.
GlaxoSmithKine also issued a "Dear Healthcare Professional" letter, in which it described the interim findings but said they were "inconclusive" as the deaths and serious adverse events reported could neither be attributed to use of Serevent, nor could Serevent be excluded as a cause.
Seeger Weiss is not currently pursuing lawsuits on this drug, but its drug warnings will remain on our radar.
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