FDA requires new warnings for asthma drugs

WASHINGTON (Reuters) - U.S. health officials said Thursday they were taking steps to reduce the use of certain asthma drugs because of serious risks, including death.

Inhaled medicines known as long-acting beta-agonists, or LABAs, must carry warnings saying they should never be used alone to treat asthma, the Food and Drug Administration said.

LABAs are sold as Glaxo's Serevent and Novartis AG's Foradil, which Merck & Co Inc markets in the United States. Two more widely used blockbuster medicines -- GlaxoSmithKline Plc's Symbicort -- combine a LABA with an inhaled corticosteroid.

The combination products should only be used in patients with asthma that cannot be controlled by other medications and should be used for the shortest time possible, FDA officials said. The agency said it will require new warnings that reflect that advice.

"The idea here is to overall decrease the use of long-acting beta agonists even as a combination product," Dr. Badrul Chowdhury, head of the FDA's pulmonary drugs division, told reporters on a conference call.

The FDA said a review found "there is an increased risk for severe exacerbation of asthma symptoms, leading to hospitalizations in pediatric and adult patients, as well as death in some patients" who used LABAs to treat asthma.

An FDA analysis presented to an advisory panel in December 2008 found 2.8 more serious asthma-related complications, including deaths and hospitalizations, for every 1,000 patients treated with a LABA.

The agency said on Thursday there was "no conclusive evidence that the combination of an asthma controller medicine with a LABA decreases or eliminates the risk." The FDA is requiring studies by the manufacturers to better understand the safety of LABAs when used with an inhaled steroid.

Advair had sales of about $7.8 billion in 2009. Symbicort's 2009 sales were about $2.3 billion.

In a statement, Glaxo Vice President Katharine Knobil said the company would work with the FDA "to ensure the final label for these products protects the interest of patients."

"It is important that doctors have flexibility to make the proper clinical decisions to help patients gain and maintain optimal control of their asthma," she said.

The company said there was "no evidence from more than 10 years of data from clinical trials, observational studies and worldwide clinical experience ... that Advair is associated with an increased risk of asthma-related death, hospitalization or other serious respiratory-related outcomes."

Companies have 30 days to agree with the FDA's proposed changes or state why they object, Glaxo said.

AstraZeneca is "confident in the positive benefit-risk profile of Symbicort," which is used by millions worldwide, spokeswoman Kirsten Evraire said. The company "supports the efforts of the FDA to share additional benefit/risk information within the product label," she said.

Merck and Novartis said they would work with the FDA to "determine appropriate next steps." The companies said they were "committed to helping ensure that healthcare providers and patients have the most accurate and complete information regarding the safe and appropriate use" of Foradil.

LABAs are approved to treat both asthma and chronic obstructive pulmonary disease. The FDA said the new warnings applied only to use in asthma.

(Reporting by Susan Heavey, Lisa Richwine and Bill Berkrot; editing by Matthew Lewis)