The FDA was scheduled to ask an advisory panel of lung experts today to determine whether three asthma drugs – GlaxoSmithKline's Advair and Serevent and Novartis' Foradil – should stay on the market or should be withdrawn due to safety concerns.
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.