FDA Issues Related To Advair

Advair and Its Uses

Advair is a combination drug containing two active ingredients Fluticasone and Salmeterol which help to prevent wheezing, shortness of breath and breathing difficulties caused by asthma. Fluticasone belongs to a class of medications called steroids that help to reduce swelling or inflammation in the airways. Salmeterol is in a class of medications called long-acting beta-agonists and works to relax and open air passages in the lungs, making it easier to breathe.

FDA and Its Concerns Regarding Advair

The Food and Drug Administration (FDA) of US keeps a check on all the medicines sold in the country and carries on a series of researches to find out if any of the medicines cause harmful effects. Advair is a prescription drug that was approved by the FDA in 2000 for the long term treatment of asthma and chronic obstructive pulmonary disease (COPD).

Over the years, a number of concerns have risen regarding the use of Advair by FDA.  According to the numerous researches carried out by FDA, a number of patients suffered from severe asthma exacerbations after using Advair. In a large clinical study, the use of Advair was found to cause increase in deaths from asthma in patients who used Salmeterol, one of the active ingredients of Advair used for relaxing the airways and making breathing easier.

Results of Advair Usage by Patients

The numerous deaths of Advair patients were considered significant. It was revealed that that out of the total number of people who added Advair to their usual treatment, 13 suffered deaths out of 13,176 patients versus 3 in 13,179 patients who took placebos or pacifying medicine.

A black-box warning, the FDA's strongest issued drug warning, was added to Advair labels in 2003, based on preliminary results of the Salmeterol Multicenter Asthma Research Trial.

FDA Meeting Regarding Advair

After the research that showed that Advair was leading to worsening of asthma symptoms, an FDA advisory committee met in July 2005 to decide if Advair should continue to remain in the pharmaceutical market. It was recommended that if patients whose asthma is quickly worsening, the use of this drug combination should be avoided. Advair is inhaled to keep the airways open to prevent asthma attacks, not to cure it.

The FDA advisory panel was asked to review the safety of Advair, as compared to other asthma drugs. The committee of 14 asthma experts convened on July 13, 2005 and reviewed the data on the drugs and went through the presentations from the manufacturers and others.