YourLawyer.com® 1-800-LAW-INFO (1-800-529-4636)
Asthma Med Serevent Linked to Serious Adverse Events, Death
Jul 18, 2008 | Parker Waichman Alonso LLP
Researchers have just revealed that patients with chronic asthma who take the asthma medication Serevent—also known generically as Salmeterol—on a daily basis are at increased risk for serious adverse events, including death
The research involved a 12-week review of 32 clinical trials that involved 62,630 patients. In addition to pointing to serious adverse events with daily Serevent use, the research findings also suggest that the collaborative use of inhaled corticosteroids with Serevent may help reduce such adverse effects. It is important to note that the researchers felt that it remains unclear if the addition of corticosteroids with Serevent eliminates the risk entirely. "We found that the biggest increase in risk was seen in people with asthma who were not taking inhaled corticosteroids; however, there is no guarantee that inhaled corticosteroids abolish the risk altogether," lead researcher Dr. Christopher Cates, from Community Health Sciences at St. George's, London, said.
The studies in the review all involved clinical trials in which participants were randomly assigned to either regular Serevent, a placebo, or the medication Salbutamol. Of all of the patients involved, 2380 were children. Serevent is a long-acting, beta2-adrenergic receptor agonist that is delivered as a dry powder and is administered with a special inhaler. Serevent is the trade name and Salmeterol is the drug’s generic name. Salbutamol is the generic name for the drug marketed as Albuterol, an asthma medication that relaxes the smooth muscle in the lungs and opens airways to improve breathing. In addition to treating asthma, Albuterol treats chronic bronchitis, emphysema, and is also used to prevent exercise-related asthma.
Using data from two large surveillance studies, the researchers found that regular Serevent use increased the risk of asthma-related mortality in patients who did not also use inhaled steroids. Also, the mortality from any cause was higher with Serevent than with placebo. And, Serevent did increase the risk of non-fatal serious events. The researchers calculate that one extra serious event arose over 28 weeks for every 188 patients who used Serevent on a daily basis. More research is needed to determine if Serevent use is more or less risky in children as compared with adults.
For those patients whose asthma is not adequately controlled by moderate doses of inhaled corticosteroids, the addition of Serevent can relieve symptoms; however, the authors warn that this relief, "… may be at the expense of an increased risk of serious adverse events and asthma-related mortality; risks which are not clearly abolished by inhaled corticosteroid."
Serevent is prescribed for long-term, twice-daily use for the treatment of bronchospasm associated with Chronic Obstructive Pulmonary Disease (COPD), including emphysema and chronic bronchitis and is also prescribed for long-term, twice-daily use in the maintenance treatment of asthma in patients four years of age and older. Also, Serevent is used for the prevention of exercise-induced bronchospasm (EIB) in patients four years of age and older.
Serevent side effects include throat irritation; sinus headache; nausea; oral “musosal abnormality”; joint pain; sleep disturbance and paresthesia, or tingling; contact dermatitis and eczema; and pyrexia, or increase in body temperature.
