Home : Unsafe Drugs : Law Articles : Use of Serevent Can Cause More Serious Asthma Attacks
Use of Serevent Can Cause More Serious Asthma Attacks
Serevent (salmeterol xinafoate inhalation powder) is an inhaled, long acting bronchodilator manufactured by GlaxoSmithKline. It is prescribed as asthma medication and for the treatment of chronic obstructive pulmonary diseases (COPD), such as emphysema and chronic bronchitis.
On November 18, 2005, the FDA alerted health care professionals and patients that several long-acting bronchodilator medicines including Serevent have been associated with an increased risk of wheezing (bronchospasm) in some people. In addition, the FDA requested that the manufacturers of these medications update their existing product labels with new warnings and include an updated medication guide for patients. The medication guide is intended to alert health care professionals and patients that these medicines may increase the chance of severe asthma episodes and, in some cases, death, when those episodes occur. The FDA updated this public Health Advisory on May 15, 2006.
Serevent and similar products contain medicines belonging to the class known as “long-acting beta 2-adrenergic agonists” (LABAs), which are long-acting bronchodilator medicines. Bronchodilator medicines, such as LABAs, help to relax the muscles around the airways in the lungs. Wheezing (bronchospasm) happens when the muscles around the airways tighten. Even though LABAs decrease the frequency of asthma episodes, these medicines may make asthma episodes more severe when they occur.
On March 2, 2006, the FDA approved the new safety labeling and medication guides for patients for Serevent Diskus (salmeterol xinafoate) and Advair Diskus (fluticasone propionate; salmeterol xinafoate) manufactured by GlaxoSmithKline. The products now carry the strongest warnings the FDA can require of prescription drugs. The "black-box" warnings on both drugs caution that the key ingredient salmeterol may increase the risk of asthma-related death.
The FDA public Health Advisory highlights recommendations about the use of all LABA medications for asthma. The advisory includes the following information:
- LABAs should not be the first medicine used to treat asthma. LABAs should be added to the asthma treatment plan only if other medicines do not control asthma, including the use of low-or-medium dose corticosteroids.
- Patients should not stop using their LABA or other asthma medicines that their health care professional prescribed unless it has been discussed with their health care provider.
- LABAs should not be used to treat wheezing that is getting worse. Patients should contact their health care professional immediately if the wheezing worsens while they are using a LABA.
- LABAs do not relieve sudden wheezing. It is important to always have a short acting bronchodilator medicine available to treat sudden wheezing.
In one asthma medicine study, an increased number of people taking a LABA in addition to their usual asthma care died from their asthma compared to people taking a placebo in addition to their usual asthma care. Although the number of asthma deaths in the study was small, this is a concern to people who suffer from asthma. The FDA has advised that Serevent should only be used as an additional medication when low to medium dose inhaled corticosteroids are not sufficient or if the asthma is serious enough to merit the use of two drugs.
Any individual who has suffered life-threatening asthma attacks or relatives with deaths related to use of Serevent may be entitled to compensation for their suffering or loss and should contact an attorney who specializes in the pharmaceutical industry.
