A panel of medical experts is meeting today to weigh whether to allow certain drugs to continue to be marketed for asthma treatment in adults and children amid lingering concerns that the products increase the risk of asthma-related deaths and side effects.
The panel of 30, made up of pediatricians, lung and allergy doctors along with drug-safety experts, is scheduled to vote today whether Advair, Foradil, SereVent and Symbicort should continue to be marketed as asthma treatments.
The panel was called in for advice because FDA officials are divided about what course of action to take. While the agency has the final say, they typically follow the advice of the panel.
The drug companies have each said their products are safe and should remain on the market for both adults and children.
The FDA’s drug-safety division recommends that the drugs not be marketed to children younger than 17 – and, in some instances, adults.
Dr. Badrul A. Chowdhury, director of the FDA division that reviews pulmonary and allergy drugs, warned that the risk of death linked with these drugs was minimal and banning their use “would be an extreme measure that could be problematic.”
Both the companies as well as the FDA presented data to the panel on Wednesday.
Some of the FDA advisers expressed frustration over the lack of fresh clinical data on drugs in use for the last ten years or more. "I think this is an impossible task you are asking us to do," said Dr. Judith Kramer, MD, who teaches medicine at Duke University Medical Center in Durham, N.C.
Prior to the meeting, the agency analyzed 110 clinical trials involving more than 61,000 patients, comparing patients who took a medication containing LABA with those who used a steroid alone to control asthma symptoms. Experts looked for deaths, hospitalizations and cases in which a patient had to have the assistance of a breathing tube.
The analysis found 20 deaths from asthma complications, of which 16 were in patients taking LABA-only drug, SereVent.
The drugs, known as long-acting beta agonists (LABAs), the subject of an FDA safety review for several years, currently carry the FDA’s strongest label warnings. The medication relaxes tight muscles around constricted airways, freeing asthma sufferers from the need to use their inhaler every few hours.
Nearly 17 million Americans have asthma. About five million of them are children. Many children outgrow asthma in their teen years. Each year, 5000 people die from asthma.
Asthma is a narrowing of the airways in the lungs brought on by hypersensitivity to certain stimuli. When these stimuli enter the lungs they cause the muscles in the airway to spasm, interfering with the airway. #