March 5, 2008 / 4:00 PM / 12 years ago

FDA requests more safety data on asthma drugs

WASHINGTON (Reuters) - U.S. health officials said on Wednesday they had requested more information from GlaxoSmithKline Plc and other makers of certain asthma drugs to further analyze the safety of the medicines.

The drugs, known as long-acting beta agonists, include Glaxo’s Advair and Serevent, Novartis AG’s Foradil, and AstraZeneca Plc’s Symbicort. They are used to treat asthma and other respiratory conditions.

The Food and Drug Administration said it had asked the manufacturers in January to provide information from controlled clinical studies of the medicines “in order to further evaluate the safety” when treating asthma.

Concerns about the class of drugs date back to 2005, when the FDA asked makers to add new warnings that the medicines may increase the risk of asthma-related deaths.

Other manufacturers include Mylan Inc, which sells Perforomist, and Sepracor Inc, maker of Brovana.

The companies said it would take several months to submit the data to the FDA, the agency said in a notice on its Web site.

The agency plans to ask a panel of outside advisers to review the drugs’ risks and benefits in adults and children in the fall or winter of 2008, the notice said.

Officials with GlaxoSmithKline, AstraZeneca and Schering-Plough Corp, which markets Foradil in the United States, said they would provide the requested information to the FDA. Other makers did not immediately respond to requests for comment.

In November 2007, an FDA advisory panel urged stronger safety warnings on Glaxo’s Serevent amid reports of deaths in children who were treated with the drug. Serevent is one ingredient in Glaxo’s blockbuster asthma treatment Advair.

FDA officials said at the time they were planning to review the safety of all long-acting beta agonists.

Asthma is a chronic disease marked by restricted breathing and wheezing, and often made worse by exercise, cigarette smoke and other factors. About 20 million people in the United States have asthma, according to the National Institutes of Health.

Makers of the drugs say the benefits of controlling asthma outweigh the risks of the long-acting beta agonists, which help keep airways open. Uncontrolled asthma can lead to severe attacks that may be fatal.

Glaxo spokeswoman Mary Anne Rhyne said the company was confident in the safety of its drugs when used appropriately. Glaxo “is aware of no new safety information that changes the benefit-risk evaluation of Serevent or Advair at this time,” she said.

Glaxo shares ended down 2.6 percent at 10.65 pounds in London. Advair is Glaxo’s biggest selling drug with 2007 global sales of 3.5 billion pounds ($6.9 billion), of which 1.9 billion pounds was generated in the United States.

The long-acting beta agonists “have been reviewed several times already, but with current political pressure and ongoing safety reviews, I’m not that surprised it has come up again,” said Ben Yeoh, pharmaceuticals analyst at Dresdner Kleinwort.

AstraZeneca spokeswoman Michele Meeker said Symbicort had an “extensive amount” of research backing its safety but the company supported the FDA review.

Schering-Plough spokeswoman Lisa Ellen said Foradil was safe when used as directed.

($1=.5052 Pound)

Reporting by Lisa Richwine and Ben Hirschler, editing by Maureen Bavdek, Gary Hill

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