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March 8, 2006—The FDA announced Serevent will include a Black Box Warning
informing patients that the drug may increase the risk of asthma-related death.
Serevent has included a Black Box Warning since August 2003 when a clinical trial assessing the
safety of Serevent found that Serevent users were more likely to suffer life-threatening asthma attacks.
The results of the study are alarming—36 people either had life-threatening attacks or died
while on Serevent. The risk of death was threefold among those taking Serevent compared to a placebo.
The FDA said that while Serevent decreases how often asthma attacks occur, the inhaler may make
the attacks that do occur more severe.
In May 2006, the FDA said that Serevent and two other asthma drugs associated with life-threatening
attacks should only be used after other medicines fail to control asthma.
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