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FDA Panel Urges Restrictions on 2 Asthma Drugs

Serevent, Foradil Inhalers Should Not Be Used Alone, Experts Urge
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"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.

"I think there's a paucity of data," Notterman said.

Symbicort is generally not used in children.

John Jenkins, MD, who heads FDA's Office of New Drugs, said the agency would consider ordering manufacturers to conduct more safety studies in children, which it can do under new authority granted by Congress.

Ellen Strahlman, MD, the chief medical officer of GlaxoSmithKline, which makes both Advair and Serevent, said the company was pleased with the committee's backing of Advair. But she also said the company was "concerned" that the panel's vote to restrict Serevent could "deny patients needed treatment for optimal care of their asthma."

A statement from Novartis and Schering-Plough said the companies "strongly disagree" with the panel's rejection of Foradil, which they market in a joint venture.

"We believe this opinion is inconsistent with clinical evidence supporting the benefit/risk profile of Foradil in patients not adequately controlled on other asthma-controller treatments," the statement read.

The FDA now has to go back and consider whether to change product labeling or indicated uses for Serevent and Foradil. It will also consider ordering new safety studies, Jenkins said.

Jenkins emphasized that patients currently taking Serevent or Foradil "should not stop taking your asthma medications without talking to your physician."

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