By: Laurie Edwards for Medtech1For the millions of patients suffering from asthma, there’s something new to consider in terms of your treatment plan: Two of the most popular asthma medications, Advair and Serevent, will carry a "black box" warning, the most stringent label put out by the Food and Drug Administration.
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Managing Asthma
Treating asthma often includes both short- and long-term medications. Remember that drugs like Serevent and Advair are meant to be preventative and will not help you during an acute asthma attack.
Since allergens and pollutants can exacerbate symptoms, it’s important to know what your personal triggers are and minimize your exposure to them.
Always consult with your physician before making any changes to your asthma treatment plan.
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The new warning is in response to a large study that found salmeterol, the main active ingredient in Serevent and one of Advair’s main ingredients, may increase the risk of asthma-related deaths. While the drugs help prevent asthma attacks from occurring in the first place, they can increase the severity of the attacks when they do happen.In November 2005, the FDA asked GlaxoSmithKline, who manufactures both Advair and Serevent, as well as Novartis, the company that manufactures Foradil, to add the black box label.
Clinical trials found that patients taking drugs containing salmeterol experienced more deaths than those taking an inactive placebo. However, the number of deaths was relatively small – 13 deaths in 13, 176.
“GSK has confidence in the proven safety profile of Serevent and Advair when these products are used appropriately. There have been over 48 million prescriptions dispensed for Serevent since introduction in 1995 and over 62 million prescriptions dispensed for Advair since introduction in 2001,” the company wrote in a news release.
Asthma, an inflammatory condition of the airways, is typically characterized by bouts of wheezing, shortness of breath, frequent cough and tightness in the chest. It affects 3 to 5 percent of adults and 7 to 10 percent of all adults. Half of asthma patients develop the condition before the age of 10, and in many, symptoms decrease over time.
For some asthmatics, inhaled allergens like pet dander, mold and pollens can trigger their attacks. Symptoms can also be exacerbated by respiratory infections, exercise, food allergies, stress or cold air. Asthma treatment includes both recognizing and limiting exposure to allergens and known triggers and using a combination of short- and long-term medications.
For people with persistent asthma, using preventative bronchodilators such as Serevent and inhaled steroids can help minimize the risk of an attack and help keep airway muscles relaxed. During an acute attack, “rescue” medications like fast-acting bronchodilators and intravenous steroids are used to alleviate symptoms.
“The new product labels communicate the benefit-risk profile of Serevent and Advair and help guide physicians in making appropriate prescribing decisions,” the company said.
Advair’s label urges that the drug should only be used when other low- to medium-dosed inhaled corticosteroids don’t work or in cases where the asthma is so severe that the benefits of the drug outweigh the potential risk.
Serevent’s label recommends that the drug be used as an additional medication when existing drugs are insufficient or if the patient’s asthma is severe enough to warrant two drugs.
The important thing to remember is that for most patients whose asthma doesn’t respond to low- to medium-dosed medications, benefits of drugs like Advair and Serevent outweigh the relatively small increased risk of death during acute attacks.
