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Serevent dangers are those serious side effect risks that have been associated with use of this prescription drug. Because of the severity of Serevent dangers, the FDA has listed Serevent among the top five most dangerous drugs available on the US prescription drug market. Serevent dangers are so great that more than thirty people have lost their lives as a result of taking this medication.
GlaxoSmithKline (GSK), the manufacturer of Serevent, has known for years that serious Serevent dangers threaten the health and very lives of those who use their product. GSK has done nothing to adequately protect consumers from potentially life threatening Serevent dangers. Serevent was originally approved by the FDA in 1994 to treat asthma and chronic obstructive pulmonary disorder.
In 1996 GSK sponsored a clinical trial designed to test the effects of Serevent compared to a placebo over the course of 28 weeks. The SMART study had to be stopped short after researchers found significant Serevent dangers. Thirty six clinical trial participants who had been taking Serevent died suddenly as a result of unknown asthma-related Serevent complications. African Americans taking Serevent in the study were three times more likely to die as a result of Serevent complications, compared to those taking a placebo. Serevent dangers were also significantly greater for patients who had not been taking corticosteroids to reduce pulmonary inflammation.
After these Serevent dangers were made known, GSK produced a number of suggestions about ways to reduce a patient’s Serevent dangers. In order to reduce Serevent dangers, the pharmaceutical company suggests that patients not abruptly discontinue use of this product as this can actually increase Serevent dangers. Serevent should also not be prescribed to replace inhaled corticosteroids. Serevent should not be used to treat the acute symptoms of asthma, which should be treated with a fast-acting bronchodilator. Despite these suggestions, GSK did nothing to adequately protect consumers from potentially fatal Serevent dangers.
In response to information about serious Serevent dangers, the FDA ordered GSK to add a black box warning to all Serevent product information. A Serevent black box warning is the strongest warning the FDA could demand short of recalling the drug from the market. GSK has yet to comply with the FDA’s request to add this black box warning. The company does warn patients of serious and possibly fatal Serevent dangers in a single sentence on patient product information, but does not provide adequate information about these risks to consumers.
Pharmaceutical companies have a responsibility to provide only those drugs whose intended benefits outweigh their possible risks and to inform patients of the possible dangers associated with their products. GSK has not adequately presented consumers with sufficient evidence about the severity of Serevent dangers.
If you are concerned about Serevent dangers, you may wish to contact a qualified and experienced attorney who can evaluate your case to determine your legal rights and options.
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