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FDA Seeks Info on Serevent, Advair, Foradil As Part of Safety Review

Mar 6, 2008 | Parker Waichman LLP

Asthma drugs, including  Serevent, Advair, Foradil, are the subject of a Food & Drug Administration (FDA) safety review.  The FDA has requested information from the manufacturers of the asthma medications as part of an ongoing safety review of the drugs in children.

Serevent, Advair and Foradil are long-acting beta 2-adrenergic agonists  that  prevent the release of substances in the body that cause inflammation of airways in the lungs. In 2005, the FDA strengthened the warning labels for the asthma drugs to state that they 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.

Asthma is a chronic disease marked by restricted breathing and wheezing, and often made worse by exercise, cigarette smoke and other factors. About 20 million people in the United States have asthma, according to the National Institutes of Health.

In November, prior to an FDA pediatric advisory panel meeting on the medications' use in children, the agency posted documents detailing 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. The FDA's pediatric advisory panel ultimately recommended that the drugs' labels needed new language more specific to children.

The FDA said it plans to ask a panel of outside advisers to review the drugs' risks and benefits in adults and children in the fall or winter of 2008. 

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