FDA Panel Urges Restrictions on 2 Asthma Drugs
Serevent, Foradil Inhalers Should Not Be Used Alone, Experts Urge
Dec. 11, 2008 - An expert panel said Thursday that the benefits of two
inhaler drugs are not worth the risks and should no longer be used to treat asthma.
The vote does not mean the two drugs, Serevent and Foradil, will be pulled
from the market. Instead, the panel strongly urged the FDA to tell doctors not
to prescribe the drugs to children or adults as a standalone asthma treatment.
The drugs are also widely prescribed for chronic obstructive pulmonary
disease. That use was not affected by Thursday's deliberations of a 27-member
FDA advisory committee.
At the same time, the experts backed two other popular asthma drugs, saying their
benefits outweigh their risks.
Serevent and Foradil are in a class of drugs known as beta-agonists. They
help control and prevent airway spasms during asthma attacks. But the drugs
have also been associated with a small but significant increase in the risk of
hospitalization and death from asthma.
Medical guidelines and the drugs' labeling recommend that beta-agonists only
be used in combination with inhaled steroids that cut down
on airway inflammation leading to attacks. The combination lowers the risks to
a level most experts believed is justified by their benefits.
But studies show that many patients do not use inhaled steroids as directed
when taking them separately from beta-agonists. At the same time, patients
often feel physical relief from labored breathing when they use their
beta-agonist inhaler. The difference can lead to many patients using the
beta-agonist alone (called monotherapy), which raises the risk of dangerous
side effects, according to FDA analyses presented this week.
"I think the label should be greatly strengthened to say that
monotherapy for asthma should basically be contraindicated" for Serevent
and Foradil, said Daniel Notterman, MD, a member of the advisory panel from the
department of molecular biology at Princeton University.
The rest of the advisors agreed. In a 17-to-10 vote, the panel said the
risks of long-term Serevent and Foradil use outweigh the benefits when used
alone. The panel cast a similar vote for adolescents with asthma and voted
unanimously that the drugs are not worth the risk in children 4 to 11 years
"The data is that single use is dangerous," said David Schoenfeld,
PhD, a panelist and professor of medicine from Massachusetts General
The panel gave broad backing to two other asthma drugs, Advair and Symbicort, in
adults. Those products contain a combination of beta-agonist and steroid drugs,
thus guaranteeing that patients get both drugs each time they take a puff.
The group was split on whether Advair should be used in children. Thirteen
panelists said Advair's benefits outweigh its risks in children, while 11 said
they did not. Three abstained.
Experts said they were uneasy with how few studies had been performed
showing Advair's safety and efficacy in children.