–July 14, 2005
A 13- member U.S. Food and Drug Administration advisory panel voted unanimously in favor of keeping three widely used asthma drugs —Advair®, Foradil and Serevent—on the market. While the FDA is not required to accept its’ advisory panel’s recommendations the agency usually does. Prior to the meeting, the FDA released a statement saying it was concerned about “severe asthma exacerbations in a small number of patients”.
The Pulmonary-Allergy Drugs Advisory Committee recommended labeling be required on Foradil, equivalent to the ones mandated in 2003 for Advair® and Serevent. The FDA panel also voted 12-0 that consumers and doctors need more information about Foradil’s potential risks. In August 2003, the FDA added black box warnings to Advair® and Serevent, its strictest issued drug warning placed on prescription medications.
At the time of the labeling changes, the agency said the decisions were based on a small but significant increased risk of life-threatening asthma attacks or asthma-related deaths seen in patients taking an active ingredient in both drugs called salmeterol. Serevent’s maker GlaxoSmithKline halted the 28-week study in January 2003.
In testimony before the U.S. Senate in November 2004, whistleblower and FDA scientist David Graham singled out Serevent. Graham had concerns regarding five drugs, and Serevent was the only drug he pointed to taken for the treatment of asthma.
The FDA is reviewing the drugs. The agency has been under a microscope from Congress for its oversight of drug safety, which was greatly intensified following the September 2004 recall of a popular painkiller Vioxx. FDA advisers have also suggested the agency look at ways to more clearly explain warnings to consumers and doctors because the current Advair® and Serevent warnings may be too easily overlooked.
About 15 million Americans are affected by asthma, a condition that causes inflammation in the airways of the lung and constriction of nearby muscle.
For more information on Serevent concerns, please contact us.
