UPDATE 3-US FDA panel: Two asthma drugs risky but Advair OK

"There is no doubt the advent of long-acting beta agonists has improved the lives of the majority of patients ... it would be in my opinion irresponsible to withdraw this medicine," said Dr. Fernando Martinez, director of the Arizona Respiratory Center at the University of Arizona.

The panel unanimously backed Advair's use in adults and voted 23-3 with one abstention for adolescents. More concern surrounded use in children, with panelists complaining there was little data to guide them. They voted 13-11 with three abstentions that Advair was safe enough for children ages 4 to 11.

The FDA could decide to revoke the approval of Serevent and Foradil for asthma, although the drugs would continue to be sold for treating another lung disease, chronic obstructive pulmonary disease.

On Serevent, the committee voted 17-10 that risks outweighed the benefits for adults and 21-6 against use in adolescents. They unanimously opposed use in children 4 to 11.

Some panelists who voted against Serevent and Foradil said they felt the drugs would be safe enough if their labels more strongly warned about serious safety concerns and the importance of using an inhaled steroid with them.

All of the makers said the drugs' benefits outweighed the risks when used as directed.

Glaxo Chief Medical Officer Ellen Strahlman said the company was concerned "it is possible that Serevent would be severely restricted and deny patients needed treatment for optimal care of their asthma."

Novartis and Schering-Plough, in a joint statement, said they "strongly disagreed" with the panel's finding that Foradil's risks exceeded its benefits.

"We believe this opinion is inconsistent with clinical evidence," the companies said. (Reporting by Lisa Richwine; editing by Matthew Lewis and Andre Grenon)