Injury News

When the FDA approved a new drug called Serevent (almeterol xinafoate) for the treatment of asthma in 1994, they were unaware of the problems to come. Serevent, manufactured by GlaxoSmithKline, later had its FDA-approved use extended to include treatment of chronic obstructive pulmonary heart disease. Used daily, Serevent controls the symptoms of asthma and is considered a long-acting bronchodilator. According to Serevent marketing material, the medication provides up to twelve hours of relief from chest tightness and wheezing related to asthma and other chest conditions. While Serevent enjoys great popularity with asthma victims, many users remain unaware that a recent study showed that users of Serevent are three times more likely to die asthma-related deaths as users of other asthma medications.

In 1996, Serevent was the subject of a study conducted by GlaxoSmithKline (due to FDA concerns). During the Serevent study, a number of participants suffered fatal asthma attacks, leading to the cancellation of the study. In all, 36 participants in the Serevent study experienced life-threatening asthma episodes, including several who died. Some of the Serevent users had such severe difficulty breathing that they were intubated to re-open their airways. African-Americans who use Serevent are at a higher risk for these problems than users of other ethnic backgrounds, and patients who do not use Serevent in combination with another drug to fight inflammation also have increased odds of complications. A safety monitoring board shut down the Serevent study, and the FDA required GlaxoSmithKline to place a black box warning (the highest level of warning) on all Serevent product packaging and marketing materials. As of December 2003, no such warning existed on any Serevent material, and there is no known target date for a warning to appear.

Patients who are currently taking Serevent should consult a physician before altering or ceasing treatment. Many individuals have benefited from the use of Serevent, but it is important to discuss all potential side effects with your doctor, to determine whether or not Serevent is the best option for controlling your asthma. If you or a loved one has suffered adverse effects or death as a result of using Serevent, GlaxoSmithKline may be liable, and you could be entitled to recover all costs associated with medical treatment, hospital and/or funeral expenses, lost wages, pain and suffering, and punitive damages.