The FDA has finalized new warnings for inhaled asthma drugs known as long-acting beta-agonists, exercising new powers to order the changes on products made by GlaxoSmithKline (NYSE: GSK) and AstraZeneca (NYSE:AZN). The warnings had been expected since February, when the agency said it was requiring manufacturers to revise their labels because of an increased risk of severe exacerbation of asthma symptoms--and even death--in some patients using LABAs for the treatment of asthma.
The updated labels will now include language stating the use of a LABA without use of a long-term asthma control medication, such as an inhaled corticosteroid, is contraindicated in the treatment of asthma. It also states that the products shouldn't be used in patients whose asthma is adequately controlled on low or medium dose inhaled corticosteroids. LABAs include such products as GlaxoSmithKline's Serevent and Advair, Merck's Foradil, and AstraZeneca's Symbicort. And, as Reuters reports, while some of the companies accepted the changes, others resisted.
"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, tells Reuters. "Not all of the companies have accepted all the changes ... so that's where the ordering comes in."
Letters announcing the final label warning were also sent to Sepracor, now part of Dainippon Sumitomo Pharma, and the maker of Brovana, and Dey Pharma, a subsidiary of Mylan that makes Perforomist.
- see the FDA statement
- check out more from Reuters
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