An FDA advisory panel will meet this week to review the asthma drugs, Advair, Serevent and Foradil, to examine whether the medications are safe for use among children. Side effects of the drugs could cause serious problems, including death, and the risks may outweigh the benefits for children.
Asthma affects about 6.5 million children in the United States. The chronic disease causes a narrowing of the airway, which is associated with wheezing and difficulty breathing. Advair, Serevent and Foradil are long-acting beta agonists, approved for the long-term prevention of asthma among those 12 years and older, whose asthma is not controlled by corticosteriods.
Serevent contains the active ingredient salmeterol, and Advair is a combo drug, containing salmeterol and a steriod. According to studies, salmeterol causes a four times increase in the risk of asthma-related deaths. Foradil, containing the active ingredient formoterol, could increase the risk of asthma exacerbations and hospitalizations. All three drugs currently contain a “black box” warning indicating that they may increase the risk of asthma-related death, but the advisory panel will evaluate whether the drugs are safe for use with children at all.
An FDA pediatric advisory committee is scheduled to meet this week, and will review the safety of Serevent, Advair and Foradil, as well as several other drugs used by children. An FDA staff memo released in advance of the hearings, indicates that Foradil, Serevent and Advair side effects may carry more risks than benefits when used for treatment of asthma for children, and recommends a more thorough analysis be conducted.
The FDA conducted a review of reported adverse safety events associated with the drugs. During the 13 month period between March 2006 and April 2007, 9 problems were reported among children using Serevent, including five deaths. Between 1994 and 2007, 23 pediatric deaths were associated with Serevent. Between 1999 and 2007, 15 pediatric deaths were associated with use of Advair.
Serevent and Advair are manufactured by GlaxoSmithKline. They are the best selling drugs made by the pharmaceutical giant, generating $6.13 billion in sales last year. Glaxo has recently suffered significant financial setbacks after their diabetes drug Avandia was linked to an increased risk of heart attacks, and they face thousands of Avandia lawsuits from users who have suffered injuries.
FORADIL, SEREVENT AND ADVAIR LAWSUITS
The lawyers at Saiontz & Kirk, P.A. are reviewing potential lawsuits for Advair, Foradil and Serevent side effects which resulted in death for the user. If your friend or loved one died as a result of one of these asthma medications, request a free consultation and claim evaluation.