Quoted from http://www.reuters.com/article/idUSN0219172120100603
US FDA orders new asthma drug warnings to take effectWed Jun 2, 2010 8:38pm EDT
WASHINGTON, June 2 (Reuters) - U.S. health regulators have finalized new warnings for controversial inhaled asthma drugs, but exercised new powers to order the changes on products made by GlaxoSmithKline Plc (GSK.L) (GSK.N) and AstraZeneca Plc (AZN.L).
The warnings, expected since February, say medicines known as long-acting beta-agonists, or LABAs, should never be used on their own to treat asthma, Food and Drug Administration officials said on Wednesday. While some of the companies accepted the changes, the two British drugmakers resisted, agency officials said.
Glaxo's Serevent and Novartis AG's (NOVN.VX) (NVS.N) Foradil, which Merck & Co Inc (MRK.N) markets in the United States, are LABA drugs. Two more widely used blockbuster medicines -- Glaxo's Advair and AstraZeneca's Symbicort -- are combination drugs that include a LABA with a corticosteroid.
Letters announcing the final label warning were also sent to Sepracor Inc, now part of Dainippon Sumitomo Pharma Co (4506.T) and the maker of Brovana, and Dey Pharma, a subsidiary of Mylan Inc (MYL.O) that makes Perforomist, the FDA said.
"FDA is ordering the involved companies to make labeling changes capturing these new recommendations," Dr. Badrul Chowdhury, head of the FDA's pulmonary drugs division, told Reuters. "Not all of the companies have accepted all the changes ... so that's where the ordering comes in."
In a statement, Glaxo said it would work quickly to include the updated warnings but did not say why the company had objected or what specific warnings it took issue with. Representatives for Glaxo did not immediately respond to a request for further comment.
AstraZeneca said in a statement that it was confident in the "positive benefit-risk profile" of Symbicort in asthma. "Patients who are currently taking SYMBICORT should continue their prescribed medication, and talk to their doctor regarding any questions they may have about their treatment," the statement said.
Wednesday's move marks the eighth time the FDA has been forced to leverage its new power to change drug labeling since Congress granted it the authority in a 2007 law.