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drug_recall sereventSerevent problems are so great that top officials in the Food and Drug Administration have listed this drug as one of the top five most dangerous prescription medications available on the US market today. Serious Serevent problems have been known for years, yet GlaxoSmithKline (GSK), the makers of Serevent, have made no substantial effort to protect consumers from the dangerous side effects of Serevent.
Serevent (salmeterol xinafoate) is a prescription drug that was approved by the FDA in 1994 to treat asthma and chronic obstructive pulmonary disorder (COPD). Serevent is contraindicated in patients who have a history of heart problems, high blood pressure, and those who are currently taking MAOIs or tricyclic antidepressants because they may be at an increased risk for Serevent problems. Commonly reported Serevent problems include: changes in heart rate, increased blood pressure, heart arrhythmias, mild anxiety, joint pain, muscle cramps, and dry mouth.
The most serious Serevent problems were exposed in a GSK-sponsored clinical trial conducted in 1996. The SMART study was originally designed to be a twenty-eight week trial but was stopped short after the discovery of serious Serevent problems. Thirty six of the clinical trial participants in the Serevent group had suffered such serious Serevent problems that they died during the study of asthma complications. African American participants were three times more likely to suffer fatal Serevent problems than those taking a dummy pill. Patients who were not concurrently taking an inhaled corticosteroid were also at an increased risk of suffering fatal Serevent problems.
After these Serevent problems were discovered, GSK issued a number of recommendations intended to help reduce the risk of fatal Serevent problems, though none of these guidelines addressed the actual risks discovered in the clinical study. GSK suggested that patients should speak to their doctor before discontinuing Serevent, that they should not use Serevent to replace inhaled corticosteroids, and that Serevent should not be used to treat acute asthma symptoms. None of these statements addresses the serious Serevent problems discovered in clinical trials.
Knowledge of fatal Serevent problems prompted the FDA to order GSK to issue a black box warning on all product information informing patients about the serious Serevent risks. A Serevent black box warning is the strongest warning the FDA can require, short of pulling a drug off the market. The FDA ordered the inclusion of this Serevent problems warning in 2002, yet the pharmaceutical company has not complied. GSK has added a short caution alluding to the serious Serevent problems, but has not adequately protected consumers from the serious dangers associated with their product.
If you or a loved one has experienced Serevent problems, you may wish to contact a qualified and experienced Serevent attorney who can evaluate your case to determine your legal rights and options. You may be able to seek relief for your Serevent problems and losses through a Serevent personal injury lawsuit.
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