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FDA Panel Urges Restrictions on 2 Asthma Drugs
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 old.
"The data is that single use is dangerous," said David Schoenfeld, PhD, a panelist and professor of medicine from Massachusetts General Hospital.
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.
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