Asthma Medication Side Effects

About 15 million Americans suffers from annoyance and pain of asthma. Asthma causes inflammation in the airways of the lungs and thus making it difficult to breathe.

Serevent, an inhaled long acting bronchodilator is a prescribed medication for asthma used for the treatment of chronic obstructive pulmonary diseases (COPD) like chronic bronchitis and emphysema. GlaxoSmithKline manufactures Serevent. GlaxoSmithKline, a global manufacturing company produces several known prescription and over the counter drugs including Serevent, Aquafresh, Tums and Nicorette.

The U.S. Food and Drug Administration approved Serevent. It works when microscopic particles are inhaled in the lungs and thus relaxing air passages. The assumption behind Serevent is that open airways leads to easier breathing.

However, use of Serevent is related to the higher risks of wheezing and severe asthma episodes in some patients. This condition occurs after the relaxation and contraction of air passages. The tighten muscles around the airways makes it difficult to breathe and in some cases persistent wheezing stops breathing completely causing death.

Soon after the introduction of Serevent to the market, there were reports of severe side effects associated with the drug.

In July 1996, a study conducted by GlaxoSmithKline raised the concerns of the U.S. Food and Drug Administration. These results were declared in January 2003. The study, Salmeterol Multi-center Asthma Research Trial (SMART) was conducted for a period of 28 weeks. This study compared Serevent and Placebo, drugs used for the treatment of Asthma. Patients using Serevent suffered from increased no. of asthma episodes and deaths to that of the patients using placebo.

In this study, out of 13,176 patients 13 patients using Serevent died while three patients out of 13,179 using Placebo died.  Deaths and adverse asthmatic events occurred in the patients not using inhaled corticosteroids at baseline. These deaths and events occurred frequently in the African American population to that of Caucasians.

In August 2003, the FDA issued black box warning against Serevent. Black Box Warning is the strongest given by FDA to any drug. This warning was issued to educate the doctors and patients about the risks associated with the use of this drug. In November 2005, FDA asked the manufacturers of Serevent and other bronchodilators to update the label of products with an Additional Medication Guide and new warnings. The purpose of this update was to alert the doctors and patients about the risks and side effects associated with the Serevent. Manufacturer of Serevent distributed a “Dear Health Care Professional” letter informing the doctors and healthcare professionals about the risks associated with the drug.

Serevent continues to be prescribed by the doctors for the Asthma treatment. However, FDA continually monitors the risks and side effects associated with drug.