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Serevent safety has become a major concern because of the risks of death and severe side effects that have been associated with this medication. On November 18, 2004 Dr. David Graham, a reviewer for the Food and Drug Administration with over 20 years of government service, named Serevent one of the top five most dangerous prescription drugs available today. Serevent safety has been a major concern for years, after reports of death and life threatening side effects were linked to Serevent use.
Serevent is a beta-2 receptor antagonist with the active ingredient salmeterol xinafoate. Serevent was approved by the FDA in 1994 to treat asthma and Chronic Obstructive Pulmonary Disorder (COPD). Serevent is manufactured by pharmaceutical company GlaxoSmithKline.
Concerns about Serevent safety peaked after a 1996 internal clinical trial on Serevent safety was halted by the FDA. The 28 week SMART trial was designed to test Serevent safety by comparing Serevent and a placebo in the treatment of asthma. This study was stopped short because a number of trial participants died as a result of serious Serevent induced respiratory complications.
Thirty six patients in this clinical study died as a result of serious Serevent side effects. African Americans and patients who were not concurrently taking drugs to fight inflammation (inhaled corticosteroids) were shown to be at a greater risk of serious Serevent side effects. The Serevent safety report did indicate that there were some discrepancies in the initial health of some trial participants that may have contributed to death in some groups more than others. The fact remains that Serevent side effects have the potential to kill or cause serious harm to patients.
The results of this Serevent safety report prompted the FDA to order that a black box warning be included on all patient packaging and advertising information. The black box warning is the strongest warning the federal government can mandate for a prescription drug. This black box warning would include Serevent safety information and caution patients and doctors that fatal side effects are possible from Serevent use.
GlaxoSmithKline has not taken any measures to include Serevent safety information on their product labeling and advertising. This company has made no indication that they plan to include this crucial Serevent safety information on any future labeling. Concerns about Serevent safety and the communication of potential Serevent health risks have not been made a priority for this pharmaceutical giant.
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