(New throughout with panel votes)
By Lisa Richwine
ROCKVILLE, Md. Dec 11 Two asthma drugs,
GlaxoSmithKline PLC's (GSK.L) Serevent and Novartis AG's
NOVN.VX Foradil, pose serious risks that outweigh their
benefits for treating adults, adolescents and children, a U.S.
advisory panel ruled on Thursday.
Two much more widely used drugs -- Glaxo's Advair and
AstraZeneca PLC's (AZN.L)(AZN.N) Symbicort -- have acceptable
safety for asthma patients of all ages, the panel said in a
series of votes.
The U.S. Food and Drug Administration will consider the
recommendations as officials decide if the inhaled drugs should
continue to be approved for treating asthma amid evidence of
deaths and serious asthma attacks in some patients.
Serevent and Foradil contain long-acting beta agonists, or
LABAs. Advair and Symbicort add an inhaled steroid to a LABA.
Panel members said use of a LABA alone appeared to increase
risks and the drugs should only be used when paired with a
"It looks like use of LABAs alone is more dangerous," said
consumer advocate Sidney Wolfe, director of Public Citizen's
Health Research Group.
The agency could decide to revoke approval of Serevent and
Foradil for asthma, but the drugs could still be sold for
treating another lung disease, chronic obstructive pulmonary
Advair is Glaxo's best-selling drug with $5.6 billion in
worldwide sales through the first nine months of the year.
Symbicort's sales for the same period were $1.5 billion.
Glaxo defended Serevent and Advair as safe and providing
benefits of better lung function, symptom relief and fewer
AstraZeneca and Novartis said the benefits of their drugs
outweighed the risks when used as directed. Schering-Plough
Corp SGP.N markets Foradil in the United States.
(Reporting by Lisa Richwine; editing by Matthew Lewis)