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The risk of Serevent death has been a major concern regarding the safety of this beta-2 receptor antagonist prescription medication. Serevent, whose active ingredient is salmeterol xinafoate, was approved by the FDA in 1994. The FDA approved Serevent''s use in patients over the age of twelve to treat asthma and Chronic Obstructive Pulmonary Disorder (COPD). Serevent is manufactured by pharmaceutical giant GlaxoSmithKline.

The risk of Serevent death prompted a recent health warning regarding the safety of prescription drug use in the United States. In November 2004, a top official from the federal Food and Drug Administration listed Serevent as one of the top five most dangerous prescription drugs available on the market today.

The dangers of Serevent death and other serious side effects were discovered through a 1996 Serevent safety study. The SMART study, a 28 week clinical trial conducted by GlaxoSmithKline was abruptly halted by the FDA after several Serevent death cases were caused by Serevent use. Thirty six patients suffered from Serevent death during this clinical trial from serious respiratory problems.

Of these Serevent death cases, it was discovered that African American patients may be more at risk for life threatening respiratory side effects than their Caucasian counterparts. Reports do note that many of the African Americans who participated in the clinical study suffered from more severe forms of asthma than other participants at the onset of treatment. GlaxoSmithKline also points out that less than one percent of the African Americans who participated in the study suffered from Serevent death.

Of these Serevent death cases, patients who were not concurrently taking an inhaled steroidal anti-inflammatory were also at greater risk for life threatening respiratory side effects from taking Serevent. Serevent death cases suggest that African Americans and patients who are not using a bronchodilator for acute symptoms have a three times greater chance of suffering Serevent death than patients who are not taking Serevent for their asthma.

After the SMART study produced several Serevent death cases, the FDA ordered Serevent''s maker to include a black box warning on all of their patient product information labeling and all subsequent advertising for Serevent. The black box warning is the strongest FDA ordered warning that is required on drug labeling. GlaxoSmithKline has not included such labeling about Serevent death risks on any of its product information, nor has it made any indication that it plans to do so in the future.

The FDA and Serevent''s makers still claim that Serevent benefits outweigh the risks of Serevent death or serious side effects. Patients that are concerned about Serevent death risks should speak with their doctor before making any changes to their asthma treatment. The abrupt termination of Serevent treatment can actually increase the risk of Serevent death and other serious side effects. Together with your doctor, you can make an informed decision about whether Serevent is an appropriate asthma treatment for you.

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