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Subscribe To Our Syndicated NewsBlack box Warning on Asthma Drugs Advair and Serevent
–March 10, 2006
Popular Asthma drugs Advair and Serevent will carry the strongest Food and Drug Administration label warning alerting millions of consumer of the increased death risk linked to one of their ingredients.
The "black box" warning on both drugs caution users of salmeterol, an active ingredient in both Advair and Serevent, which poses the risk of asthma-related death.
In November 2005, the FDA asked GlaxoSmithKline, the manufacturer of both drugs, to revise the product labels due to the results of a new study, which revealed the serious side effects associated with the use of Advair and Serevent.
The large study reported that more people using Advair or Serevent died due to their asthma compared to those take a placebo drug. However, the overall number of asthma deaths in the study was small with 13 deaths out of 13,176 patients.
The new updated label advises that Advair be used only when other asthma drugs don't work, or if their asthma is severe enough to merit the use of two medications.
The Serevent warning advises the drug should only be used with another medication if other low-to-medium-dose asthma drugs are insufficient, or the need of two drugs is necessary.
In a statement released by GlaxoSmithKline, the company said they were pleased to reach an agreement with the FDA regarding the label changes on Advair and Serevent.
"The new product labels communicate the benefit-risk profile of Serevent and Advair and help guide physicians in making appropriate prescribing decisions," GlaxoSmithKline said.
In addition to the revised label warnings, the FDA has also issued new medication guides for the two drugs urging asthmatics to speak with their doctors about the risks and benefits of the medications before using them.
Advair and Serevent are used to control and prevent asthma-related symptoms such as wheezing and shortness of breath.
Contact us today to find out more information about Advair and Serevent drug safety, or to speak with a qualified attorney.
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