Asthma-Related Deaths May Increase
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March 7th, 2006
"Asthma Drugs Advair and Serevent Get Black Box Warning"
Two of the most popular asthma medications, Advair and Serevent, will carry the strongest warning label alerting consumers of the heightened risk of death associated with an ingredient found in these drugs.
The new “black box” warning cautions users of salmeterol, one of the active ingredients in Advair and the active ingredient in Serevent. A large U.S. study found that salmeterol may increase the risk of asthma-related deaths.
In November 2005, the Food and Drug Administration asked for the black box warning labels for the two drugs as well as a third asthma medication, Foradil. The FDA and Foradil''s maker, Novartis, continue to discuss the label update, but no final decision has been reached.
According to a statement from Advair and Serevent''s manufacturer, GlaxoSmithKline, the company was satisfied that it had reached an agreement with the FDA on the label changes.
“The new product labels communicate the benefit-risk profile of Serevent and Advair and help guide physicians in making appropriate prescribing decisions,” GlaxoSmithKline said.
The new Advair warning label advises the drug should only be used when other asthma medications like the low-to medium-dose inhaled corticosteroids don''t work, or if the asthma is so severe, the medication would be beneficial for the patient.
The Serevent label recommends patients should only use the drug as an additional medication when other low-to medium-dose corticosteroids are insufficient, or if the asthma is severe enough to use two drugs.
In addition, the FDA released new medication guides last Friday for consumers of the GlaxoSmithKline medications. The letter advises patients using Advair or Serevent to discuss the relative risks and benefits of the drugs with their doctor.
The medications are prescribed to help control and prevent symptoms of asthma such as weezing and shortness of breath. They also allow the muscles around the lungs to stay relaxed.
Are you taking Serevent?
Contact a Serevent attorney if you have been adversely affected by this drug.
