Advisory panel to consider withdrawal of asthma drugs
The FDA said the safety concerns had arisen because the drugs "have been associated with severe asthma exacerbations " in small numbers of patients.
Advair and Serevent, which contain the compound salmeterol, already carry warnings after a study found 13 deaths in 13,176 patients who took the drugs, versus 3 in 13,179 who took placebos. Foradil – with the active ingredient formoterol -- was not included in the study and does not carry a warning.
The advisory panel is comprised of 14 asthma experts who are expected to review data on the drugs, listen to presentations from manufacturers and others, and then vote on a course of action.
Global sales of Advair, sold overseas as Seretide, were more than $4.5 billion in 2004 with U.S. sales reaching close to $3 billion, according to figures from IMS Health. Serevent's global sales were $639 million last year and Foradil's $320 million.