In August 2003, the FDA announced the addition of new safety information and warnings to the labeling for drug products that contain salmeterol, including Advair. The new labeling includes a boxed warning about a small, but significant, increased risk of life-threatening asthma episodes or asthma-related deaths observed in patients taking salmeterol in a recently completed large U.S. safety study. The Advair inhaler is linked to serious side effects including severe asthma-attacks and sudden death among patients.
The combination preparation fluticasone/salmeterol is a formulation containing fluticasone propionate and salmeterol xinafoate used in the management of asthma and chronic obstructive pulmonary disease (COPD). It is marketed by GlaxoSmithKline under various trade names including Advair and Seretide.
Fluticasone, a corticosteroid, is the anti-inflammatory component of the combination, while salmeterol treats constriction of the airways. Together, they relieve the symptoms of coughing, wheezing and shortness of breath better than either fluticasone or salmeterol taken on its own.
Advair is available in 3 dosage strengths. The smallest dosage is 100/50, the intermediate dosage is 250/50 and the highest dosage is 500/50. The first number in the dosage description is how many micrograms of fluticasone propionate and the second number how many micrograms of salmeterol.
The fluticasone/salmeterol combination is delivered through a dry-powder device termed by Diskus. These purple disk-shaped containers are about 3.5 inches (8.9 cm) across and about 1 inch thick (2.5 cm). The diskus container holds small pellets of the drug combination, which are crushed on a dose-per-dose basis into a fine powder utilizing an internal mechanism activated by pressing a small lever on the side of the container. The powder is then inhaled directly into the lungs through a mouthpiece. Fluticasone/salmeterol is usually inhaled twice a day.
Litigation:
Prior to the revision of the warning label, consumers were not made aware of the risk of suffering a fatal asthmatic attack as a result of using Advair and other salmeterol based drugs. The failure to place a proper label warning was negligent on the part of GlaxoSmithKline. This company may be liable for some of the injuries and deaths caused by their products.
If you or a loved one has been injured as a result of using Advair, then you may be eligible for compensation. Please use our contact form to learn more about your legal rights associated with Advair and other salmeterol-based drugs.
