Serevent Facts:

On November 15, 2005, the FDA issued a public health advisory about potentially fatal side effects from two GlaxoSmithKline asthma drugs. The agency is asking the maker of the drugs, Advair Diskus and Serevent Diskus, to add warnings to their labels that these medications "may increase the chance of severe asthma episodes, and death when those episodes occur." This seems to occur because although LABAs relieve asthma symptoms, they also promote bronchial inflammation and sensitivity without warning.

A black-box warning, the FDA's strongest issued drug warning, was added to Advair labels in 2003, based on preliminary results of the Salmeterol Multicenter Asthma Research Trial. The Advair warning labels were issued after the post-marketing study of Serevent study showed a small number of patients experienced severe exacerbations of their asthma, and it suggested African-Americans were particularly at risk.

The number of deaths in Advair patients was considered small but significant, revealing people who added the drugs to their usual treatment suffered 13 deaths in 13,176 patients versus 3 in 13,179 who took placebos. In November 2004, FDA whistleblower Dr. David Graham singled out Serevent as one of five drugs that may be linked to serious safety concerns when testifying about what he called the FDA's inability to protect the public from unsafe drugs.

The manufacturer also sent out an additional warning in the form of a "Dear Health Care Professional" letter informing health care providers of various serious risk; however, they described the interim findings as "inconclusive" as the deaths and serious adverse events reported could neither be decisively attributed to use of Serevent.

Usage:

Serevent (Salmeterol) is a long acting beta-adrenoceptor agonist (LABA), usually only prescribed for severe persistent asthma and/or chronic obstructive pulmonary disease COPD. Salmeterol, marketed and manufactured by GlaxoSmithKline in the 1980s and was released as Serevent in 1990.

Inhaled salmeterol works like other beta 2-agonists, causing bronchodialation by relaxing the smooth muscle in the airway so as to treat the exacerbation of asthma; however, unlike stronger fast-acting inhalors which control symptoms for only 4-6 hours, Serevent lasts approximately 12 hours. The long duration is achieved because molecules initially diffuse into the plasma membrane of the lung cells, and then they are slowly released back outside the cell where they can come into contact with the beta-2 adrenoceptors. When used regularly every day as prescribed, inhaled Salmeterol can decrease the number and severity of asthma attacks.

Litigation:

Serevent is used by itself and also as one of two ingredients in GlaxoSmithKline's asthma treatment Advair, the company's biggest product with sales of $4 billion a year. GlaxoSmithKline maintain that the benefits of Severvent and Avandia outweigh its risks. According to the FDA, clinical trials demonstrated an increased rate of asthma-related deaths, by a factor ranging from three to eight times greater than patients receiving no medication.

If you have experienced a near-fatal asthma attack or if a loved one has died from asthma while using the asthma medications Serevent, Advair, or Seretide, or other asthma products containing salmeterol, you may be entitled to compensation. Please fill out the contact form to the right and an experienced DrugSettlement.com products liability attorney or representative will call you to discuss your rights.

If you or a member of your family may have been injured as a result of a pharmaceutical drug, please contact the defective drug lawyers at the Law Office of Nix and McIntyre.

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