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drug_recall sereventThe most recent Serevent warning concerns came after a top official for the Food and Drug Administration reported in November 2004 that Serevent is in the top five most dangerous prescription drugs available to US consumers. Serevent (salmeterol) is a prescription drug produced by pharmaceutical company GlaxoSmithKline. Serevent was approved by the FDA in 1994 as a long term treatment of asthma and Chronic Obstructive Pulmonary Disorder (COPD). It is estimated that approximately sixteen million people in the United States suffer from asthma.
Serevent warning information indicates that there are some common side effects that can result from taking this beta-2 receptor antagonist. Common side effects from Serevent use can include dry mouth, mild anxiety, joint pain, and muscle cramps. There are, however, more serious side effects that pose a threat to Serevent users.
In 1996, GlaxoSmithKline initiated a 28 week safety study of Serevent''s long and short term effects on patient health, called the SMART study. This study was cut short because of the serious health risks that were discovered in trial patients. Thirty six patients in the study died from asthma attacks that were thought to be the result of Serevent use.
African Americans and patients who were not taking anti-inflammatory medication in conjunction with Serevent were shown to be at a higher risk for potentially life threatening side effects. This study showed that patients taking Serevent are three times lore likely to suffer life-threatening asthma attacks than patients who were not taking this medication.
In light of this study, the FDA ordered a black box Serevent warning to be included on all patient information labeling and all Serevent advertising. The company has yet to issue this black box Serevent warning on their product information. The black box Serevent warning, the FDA''s strongest drug warning label, is used to clearly communicate the dangers associated with prescription medications.
Both the FDA and Serevent''s makers insisted in spite of this Serevent warning that the benefits of using this asthma medication still outweighs the potential risks associated with its use. GlaxoSmithKline points out that only one percent of the patients in their clinical trial experienced life threatening side effects.
If you are concerned about Serevent warnings, it is important to speak with your doctor before making any alterations to your asthma treatment. The abrupt discontinuation of Serevent can actually exacerbate asthma symptoms. In light of Serevent warnings, patients and doctors should decide together based on a patient''s severity of symptoms and other health factors whether Serevent is an appropriate asthma treatment. If you are in a high risk category, as defined by the Serevent warning, or have suffered serious side effects as a result of taking Serevent, you may wish to contact a legal professional who can advise you of your legal rights and options in a civil lawsuit.
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