FDA Panel Urges Restrictions on 2 Asthma Drugs
Serevent, Foradil Inhalers Should Not Be Used Alone, Experts Urge
"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