FDA requests more safety data on asthma drugs

By Lisa Richwine

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.