Advair® Black Box
(800) 889-3898
In August 2003, an Advair® black box warning was added to the drug's labeling informing consumers about rare, but serious, risks posed by GlaxoSmithKline's blockbuster medication. Advair® was approved by the FDA just three years prior to treat asthma and chronic obstructive pulmonary disorder. Advair® contains two active medications to reduce inflammation and open the airways and prevent asthma symptoms and attacks.
The first medication in Advair® is an anti-inflammatory steroid that is used to reduce irritation and inflammation of the airways. The other medication is salmeterol, a beta-agonist long-acting bronchodilator, which relaxes and opens the airways. It is this latter ingredient that may cause serious side effects for which the Advair® black box was issued.
In 1996, GlaxoSmithKline put its other asthma medication to the test in the SMART clinical study. This 28-week trial was designed to determine the safety and effectiveness of Serevent, whose active ingredient is salmeterol, compared to a placebo. Thirteen of the 13,179 trial participants taking Serevent died from a severe asthma attack brought on be the medication itself. Three of the 13,176 participants in the placebo group died during the study.
Because Advair® has the same active ingredient as Serevent, Advair® also received the same black box warning added to Serevent medications. Though the SMART study indicated an increased risk of fatal asthma attacks brought on by the medication, the drug company and the FDA failed to take any immediate action to protect consumers. It took these organizations seven years to officially inform patients of these life-threatening risks.
The Advair® black box warning was finally added to product labeling seven years after the salmeterol study and three years after this drug was approved for use in the United States. The Advair® black box warning states that patients face a rare, but significant, risk of suffering a fatal asthma attack caused by use of this medication. For unknown reasons, this risk is greater in the African American patient population.
Though the Advair® black box warning informs patients of this serious risk, adequate clinical studies have not been conducted using Advair® to determine its safety and effectiveness. Its maker does point out that because Advair® contains an additional active ingredient, it is unclear exactly what risks are posed by this medication.
Two years after the Advair® black box warning was issued, the FDA assembled an advisory panel of 14 lung experts to determine whether or not Serevent and Advair® should remain on the market. The panel voted unanimously to keep these drugs on the market, believing that, for most patients, the benefits of these medications far outweigh the risks.
If you would like to learn more about the Advair® black box warning or have been injured by this medication, please contact us to speak with a qualified and experienced attorney in your area.
