Michigan Social Security Disability Law Blog

According to the FDA, the risks of two common asthma medications may outweigh the benefits for many people. The health panel identified these two medications as GlaxoSmithKline’s Serevent and Foradil. Glaxo’s biggest selling drug, Advair, was excluded.

The health experts did not suggest abandoning the use of Serevent and Foradil. Instead, they recommended that drug warning labels strongly urge doctors to use the medications with an inhaled corticosteroid.

That may explain why Advair was spared. Serevent contains just one active ingredient, salmeterol, while Foradil contains only formoterol. Advair is a combination of both salmeterol and fluticasone (an inhaled corticosteroid). All of these drugs relax airway muscles, letting asthma patients breathe more easily.

The debate over these drugs has gone on for several years and two FDA officials recently called for banning the use of these drugs for anyone under age 17. Studies of people using the medications have already resulted in a warning on the label that the medications could “increase the risk of asthma-related death.”

The FDA advisory panel voted that the benefits of Serevent did not outweigh its risk as maintenance therapy for adults or for adolescents age 12 to 17. The panelists unanimously voted that the benefits of the two drugs did not outweigh the risks for children under age 12.

One official told the panel that more than 14,000 people might have died since 1994 after taking the drugs, while another suggested that an even greater number might have died without them.

The panel was reviewing an FDA study of 110 trials, including 60,954 people, which found increases in asthma-related hospitalizations, asthma-related intubations, and asthma-related deaths in asthmatic patients using the two drugs. Among the 20 asthma-related deaths identified in the study, 16 were people taking long-acting beta agonists and only four were not taking these drugs. All the deaths were in patients taking Serevent, the FDA noted. The greatest risk appeared to be among children ages 4 to 11 and women.

After the panel voted, the manufacturers of Foradil, Novartis and Schering-Plough, insisted that the new the FDA restrictions and safety warnings were unnecessary.

At the Bernstein Law Firm, we are dedicated to protecting the legal rights of consumers injured by defective products. If you or a loved has been injured due to a product defect, contact one of our experienced attorneys immediately.