FDA Panel Indicates Foradil and Serevent Should Not Be Used for Asthma

An FDA advisory panel, which met Wednesday and Thursday to review long-acting asthma inhaler risks, has indicated that Foradil and Serevent should no longer be approved for treatment of asthma. However, the panel indicated that the more popular asthma drugs Advair and Symbicort, which combine Serevent and Foradil respectively with inhaled steroids, should remain available for adults and children, despite the increased risk of severe asthma attacks and death.

All four medications are known as long-acting beta agonists (LABAs), which are taken on a daily basis to prevent asthma attacks which occur due to inflammation of airways in the lungs. They have been shown to be effective in keeping airways open, but studies have also found that they may potentially increase the severity of future asthma attacks, especially among children.

Asthma affects 20 million Americans, including 6.5 million children. It is a chronic disease with symptoms like wheezing, difficulty breathing and spasms, which can severely limit activities and impact quality of life.

FDA officials have been divided on the safety of the long-acting asthma inhalers and whether the benefits provided by the medication outweigh the increased risk of severe attacks or asthma deaths.

Prior to the FDA advisory panel meeting, several agency officials suggested that the use of long-acting beta agonists, either with or without the inhaled steroids, should be limited. Two FDA officials concluded that none of the drugs should be given to asthma patients of any age, and a third suggested that Advair and Symbicort should only be permitted for use by adults, due to the higher risk among children under 18.

The advisory panel voted on Thursday afternoon to recommend that the FDA remove approval for use of Serevent and Foradil to treat asthma, but indicated that Advair and Symbicort should remain available for asthma sufferers of all ages, including children.

GlaxoSmithKline PLC, which manufactures both Serevent and Advair, released a statement in support of their medications.

“Serevent, when used with an (inhaled corticosteroid) ICS, is an important treatment option for some patients as outlined in national guidelines,” said Dr. Ellen Strahlman, Chief Medical Officer for GSK. “We are confident that our proposed new labeling, medication guide and risk management plan would help physicians safely manage the appropriate use of Serevent in conjunction with an ICS. We are concerned that — if the FDA adopts the panel’s recommendation on Serevent — it is possible that Serevent would be severely restricted and deny patients the required treatment for optimal care of their asthma.”

Although the FDA is not required to follow the recommendations of their advisory panels, the agency usually does. Pending any final regulatory decisions, the FDA has indicated that patients should not stop taking any of the medications without first consulting with their doctors.