A clinical trial undertaken to assess the safety of Serevent produced alarming results.
The study demonstrated that Serevent users were more likely to suffer life-threatening asthma
attacks. Fifty patients out of 13,176 given Serevent either died or suffered a life-threatening
asthma attack during the course of the clinical trial.
Dr. David Graham, associate science director of the FDA Office of Drug Safety, testified before
the U.S. Congress that Serevent poses a significant health risk and urged more stringent action
be taken to protect patients. Dr. Graham believed the August 2004 warnings issued by the FDA
did not go far enough to protect those taking the drug. |