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Serevent and Advair May Cause Injury, Death in Children, FDA Report Says
Nov 26, 2007 | Parker Waichman Alonso LLP
Serevent and Advair, top-selling asthma drugs, will take center stage this week, when a Food & Drug Administration (FDA) panel meets to discuss the use of these medications in children. A report prepared by FDA staffers and posted on the agency's website indicate that both Serevent and Advair can have rare but deadly side-effects when used in children.
Serevent and Advair, both manufactured by GlaxoSmithKline, are inhalation powders used to prevent asthma attacks. Asthma is a chronic lung disease that causes inflammation and narrowing of the airways in the lungs. Asthma attacks cause shortness of breath, cough, chest pain and other symptoms. Serevent and Advair contain long-acting beta 2-adrenergic agonists that prevent the release of substances in the body that cause inflammation of airways in the lungs. Both Serevent and Advair are used to prevent asthma attacks, and do not work if an asthma attack that has already begun. Advair and Serevent are also used to treat chronic obstructive pulmonary disease (COPD) associated with chronic bronchitis.
At a meeting that begins tomorrow, the FDA Pediatric Advisory Committee will discuss the use of Advair and Serevent in children. According to documents posted on the FDA website last week, nine patients under the age of 16 where injured while taking Serevent, and five died since the medication was approved for children in 2006. The FDA reviewers who posted the Serevent and Advair information did not identify whether the adverse events cited in the documents where unique to children, but they did write that Serevent might carry more risks than benefits for young users. The FDA report said that a study to assess the benefits and risks of Serevent and Advair might be needed, however, it conceded that would be difficult to find enough children to participate in such a clinical trial. Instead, the FDA report recommended that a more "formal" analysis of data regarding Serevent and Advair be conducted.
In 2005, the FDA strengthened the warning labels for Serevent and Advair, as well as Foradil, a similar drug made by Novartis AG, warning that these asthma drugs should be reserved for patients who did not respond to other asthma therapies. The label changes came after a study found that patients taking Serevent where four times more likely to suffer an asthma-related death. Others showed that Serevent and Foradil increased asthma exacerbations and hospitalizations in both adults and children.
In a statement, GlaxoSmithKline said that it remained confident that Serevent and Advair are safe drugs, and their benefits outweigh any risks. Serevent and Advair are the second best-selling medications in the world, with sales of more than $6 billion.
