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drug_recall sereventBecause of adverse Serevent reactions, top FDA officials have listed this asthma medication as one of the top five most dangerous drugs available on the market today. Serevent (salmeterol xinafoate) is a prescription medication manufactured by GlaxoSmithKline. The FDA approved Serevent in 1994 as a long term asthma and chronic obstructive pulmonary disorder (COPD) treatment for patients four years and older.
Severe Serevent reactions were discovered in a twenty-eight week clinical trial called SMART. In July 1996, researchers conducting this GlaxoSmithKline-sponsored clinical trial found alarming rates of Serevent reactions in patients. The study had to cut short because of the severity of patient’s Serevent reactions. During the trial, thirty six patients suffered asthma-related Serevent reactions so severe that they died as a result.
The risk of death from Serevent reactions was three times greater in African American patients taking Serevent compared to those taking a placebo. The number of deaths from serious Serevent reactions also occurred with greater frequency in patients who did not use a drug to control inflammation.
Despite this knowledge of fatal Serevent reactions, the FDA and GlaxoSmithKline have taken no steps to protect patients from the serious side effects associated with this prescription medication. The FDA requested that a black box warning be added to all Serevent product packaging and advertisements in order to inform patients about the risk of Serevent reactions. The black box warning is the strongest warning that the FDA can mandate, short of pulling a drug off the market completely.
Though the FDA ordered the inclusion of a black box warning, the pharmaceutical company has not added this type of Serevent reactions warning to their product information. The company has, however, included warning statements about Serevent reactions risks to their product information, stating that rare and deadly side effects may occur while taking Serevent.
Product information also suggests that patients may experience heart related Serevent reactions. Patients who take Serevent may experience changes in heart rhythm, rapid heart rate, and high blood pressure. Other more common Serevent reactions include dry mouth, mild anxiety, muscle cramps, and joint pain. Patients may also be at a greater risk of suffering adverse Serevent reactions if they are currently taking tricyclic antidepressants, MAOIs, or suffer from heart conditions or high blood pressure.
If you are concerned about Serevent reactions, you may wish to speak to your health care provider in greater detail.
If you or a loved one has been injured as a result of Serevent reactions, you may wish to contact a qualified and knowledgeable legal professional who can evaluate your case to determine your legal rights and options.
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