What is Serevent?
Serevent is an asthma drug manufactured by GlaxoSmithKline. Asthma is a condition in which inflammation of the airways causes airflow to and from the lungs to be restricted. An estimated 16 million patients in the U.S. have asthma, and the number of asthmatics has increased significantly in recent decades. The FDA approved Serevent Inhalation Aerosol in 1994 to treat asthma. This approval was later extended to use for treatment of chronic obstructive pulmonary disease (COPD). Serevent belongs to the class of asthma medications known as beta2-receptor agonists (commonly called "beta agonists"). The active drug in Serevent, salmeterol, is also contained in the asthma drugs Serevent Diskus and Advair Diskus, also manufactured by GlaxoSmithKline.
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SMART study and Negative side effects of Serevent
A large placebo-controlled safety study of Serevent referred to as Salmeterol Multi-center Asthma Research Trial (SMART) was started in July 1996, after the FDA received reports of several asthma deaths associated with the use of Serevent Inhalation Aerosol, and after studies raised concern about the regular use of short-acting and long-acting beta-agonists. In early 2003, GlaxoSmithKline announced that it was stopping the SMART study after an interim analysis revealed an increased risk of asthma-related deaths and life threatening episodes among patients given the drug (13 deaths out of 13,176 patients treated for 28 weeks versus, 3 of 13,179 for those on placebo). The FDA says that further analysis of the data suggests that the risk might be greater in African-Americans. A previous study has reported that 36 patients who used Serevent died or suffered serious but not fatal asthma attacks.
Serevent and Black Box Warning
After the results of the SMART study were released, the FDA required that a "black box" warning be placed on Serevent. Black box warnings are the strongest warnings available to the FDA, and are meant to give health care professionals a clear understanding of a potential medical complication associated with a drug. GlaxoSmithKine also issued a "Dear Healthcare Professional" letter, in which it described the interim findings but said they were "inconclusive" as the deaths and serious adverse events reported could neither be attributed to use of Serevent, nor could Serevent be excluded as a cause.
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Serevent Senate Hearing
Most recently, Dr. David Graham, a drug reviewer in the FDA's Office of Drug Safety, testified before the Senate Finance Committee that Serevent was one of his five most worrisome drugs. He said the FDA has "reports of people dying clutching their Serevent inhaler." Dr. Graham testified that in his 20 years at the FDA, he had recommended that 12 drugs be withdrawn. Only two of those drugs are still being sold, he said.
Questions and Consultations
If you or a family member has used the prescription drug Serevent and noticed adverse side effects, you should contact a physician immediately. If you would like to discuss your rights, are interested in more information on Serevent litigation, or if you have information about the cases that you would like to share with us, please click here to fill out a short evaluation form, and a member of Seeger Weiss LLP's experienced staff will call you to discuss your potential rights concerning Serevent. Attorney consultations incur no obligation on your part and all initial consultations are free of charge and do not create an attorney-client relationship. Seeger Weiss LLP has office locations in both New York and New Jersey and its attorneys practice in courts throughout the country.
Link To Lawyer Seek's Serevent Content:
<a href='http://www.lawyerseek.com/Practice/Pharmaceutical-Injury-C1/Serevent-P17/'>Serevent: Lawyer Seek</a> |
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