Name: Serevent diskus inhaler
Generic: Salmeterol xinafoate
Date approved: 1994
Status: Prescription only – black box warning
Approved uses: Treatment of asthma
Off-Label uses: N/A
• Can cause serious asthma attacks sometimes resulting in death
• Swelling of face
• Difficulty Breathing
• Chest Pain
• Fast Heartbeat
Related topics: Unsafe drugs
Serevent & Asthma Attacks
Serevent, or salmeterol xinafoate, is an inhaled bronchodilator made by GlaxoSmithKline. Although Serevent is used to treat asthma, users are at an increased risk for severe asthma episodes when taking salmeterol. Problems occur when the drug forces airways to slacken, then contract. When the airways contract, it is more difficult to breathe. In a test, patients using Serevent were more likely to die of a severe asthma attack then those on a placebo medication.
Serevent – Is your Asthma Medication Actually Hurting You?
Approximately 15 million Americans suffer from the pain and annoyance of asthma. Asthma is a condition that causes inflammation in the airways of the lungs and makes it difficult to breathe. There are varying degrees of severity of asthma, and many medications on the market to help treat its symptoms.
Serevent (salmeterol xinafoate inhalation powder) is an inhaled, long acting bronchodilator manufactured by GlaxoSmithKline and is prescribed as an asthma medication and for the treatment of chronic obstructive pulmonary diseases (COPD), such as emphysema and chronic bronchitis. GlaxoSmithKline manufactures many well known over the counter and prescription drugs including Nicorette, Aquafresh and Tums.
A Food and Drug Administration (FDA) approved drug, Serevent works when microscopic particles are inhaled into the lungs, causing air passages to relax. The theory behind Serevent is that keeping the airways open may result in easier breathing.
However, Serevent is associated with the increased risks of increased wheezing and more serious asthmatic episodes in some patients. It occurs after the drug causes the air passages to relax and then contract. When the muscles around the airways tighten, it makes it significantly harder to breathe and, in severe cases, wheezing can stop breathing entirely and cause death if not appropriately treated.
Shortly after the release of Serevent into the marketplace, reports of serious adverse side effects, including death, surfaced.
According to the FDA, additional concerns rose after a study initiated by GlaxoSmithKline in July 1996 showed some startling results. In January 2003, these results were announced. The Salmeterol Multi-center Asthma Research Trial (SMART), a 28-week safety study comparing Serevent and placebo in the treatment of asthma, showed that a significantly higher number of asthma patients suffered serious asthma episodes. These episodes included asthma-related deaths, when treated with Serevent as an addition to their regular asthma medication, as opposed to those who took a placebo in addition to their regular asthma medication.
In this study, 13 of 13,176 people on Serevent died as opposed to three deaths out of 13,179 people on placebo. The increased deaths and serious asthmatic events occurred mainly in people who were not taking inhaled corticosteroids at baseline. They also occurred more frequently among the African American population (17% of the study population) than Caucasians (71% of the study population).
In August 2003, the FDA mandated a “black box” warning for Severent, the highest warning level possible for FDA approved drugs, to educate patients and their doctors of the increased risks. In November 2005, the FDA requested that the manufacturers of Serevent and several other long lasting bronchodilators update their product labeling with new warnings and an additional Medication Guide. The purpose of these additions and updates was to alert patients to the possible adverse side effects of Serevent, including the increased risk of severe asthma episodes, sometimes resulting in death. The manufacturer also sent out an additional warning in the form of a “Dear Health Care Professional” letter informing health care providers of various serious risks.
Serevent, which may induce asthma complications in rare circumstances, continues to remain a treatment option for asthma. The FDA is continuing to monitor the potential side effects of Severent.