GSK responds to FDA’s labeling recommendations for asthma drugs
RESEARCH TRIANGLE PARK, N.C. British drug maker GlaxoSmithKline issued a response to new labeling requirements proposed by the Food and Drug Administration for a class of asthma drugs that an analysis by the agency indicated may lead to an increased risk of hospitalization or death among patients.
The FDA announced Thursday that an analysis of clinical trial data for drugs known as long-acting beta-agonists, including GSK’s Advair (salmeterol and fluticasone propionate), had indicated an increased risk of worsening of symptoms and death in patients and would require them to be used in conjunction with asthma controller medications such as inhaled corticosteroids.
“We will work with FDA to ensure that the final label for these products protects the interest of patients who suffer with this chronic and serious disease,” GSK VP respiratory clinical research Katharine Knobil said in a statement. “It is important that doctors have flexibility to make the proper clinical decisions to help patients gain and maintain optimal control of their asthma.”
GSK, however, said there was no evidence from more than 10 years of clinical trials, observational studies and clinical experience that Advair was associated with increased risk of death from asthma, hospitalization or other serious problems. The drugs, also known as LABAs, are also used to treat chronic obstructive pulmonary disease, but the FDA’s requirements cover only the drugs’ use to treat asthma.
Merck and Novartis, which make the LABA Foradil Aerolizer ( formoterol fumarate), said they would work with the FDA to assess the new requirements and “determine appropriate next steps.”
FDA warns patients about asthma drug risks
ROCKVILLE, Md. Drugs belonging to the class called long-acting beta agonists should never be used alone for treating asthma in patients and should be combined with other asthma drugs, according to a new warning by the Food and Drug Administration, which is requiring that pharmaceutical manufacturers add the warning to the drugs’ product labels.
The FDA conducted an analysis of clinical trials showing that use of the drugs can increase risk of severe worsening of asthma symptoms, requiring children and adults to be hospitalized and sometimes resulting in death. Instead, the agency said, the drugs should be used only in combination with asthma controller medications such as inhaled corticosteroids, and should only be used long term in patients whose asthma is not adequately controlled by asthma controller medications, but should otherwise be used for the short term.
The drugs used in the analysis, also known as LABAs, include GlaxoSmithKline’s Serevent (salmeterol xinofoate) and Foradil (formoterol fumarate), made by Novartis and Schering-Plough Corp. –– now part of Merck & Co. –– as well as combination LABA-inhaled corticosteroid drugs such as AstraZeneca’s Symbicort (budesonide and formoterol fumarate dihydrate) and GlaxoSmithKline’s Advair (fluticasone propionate and salmeterol).
“Although these medicines play an important role in helping some patients control asthma symptoms, our review of the available clinical trials determined that their use should be limited, whenever possible, due to an increased risk of asthma exacerbations, hospitalizations and death,” FDA Center for Drug Evaluation and Research Division of Pulmonary and Allergy Products director Badrul Chowdhury said.
Walgreens named ‘innovative healthcare company’ by magazine
DEERFIELD, Ill. “Fast Company” magazine ranked one of the nation’s largest drug store chains among the most innovative companies in the healthcare industry.
Walgreens was recognized for leadership in healthcare services, transforming itself from a pure dispenser of drugs to a community health provider. From its national network of Take Care Clinics, to such health-and-wellness initiatives as chronic disease management program Walgreens Optimal Wellness, the company was highlighted alongside other healthcare innovators like Kaiser Permanente and Cisco. To create this year’s “Most Innovative Companies” issue, the magazine’s editorial team analyzed information on thousands of businesses across the globe and selected which companies defined the many forms of innovation that exist across the business landscape.
“We are thrilled to be named in the pages of ‘Fast Company’ among the world’s most innovative organizations,” said Colin Watts, Walgreen chief innovation officer. “To be recognized for our innovation in health care is especially gratifying as it validates the significant investment and progress we are making toward our goal of truly becoming a trusted community health provider and in making a measurable and important difference in our customers’ and patients’ lives.”
Added Walgreens EVP pharmacy Kermit Crawford, “We are creating an environment in which our nearly 70,000-strong healthcare providers can deliver the full extent of care their training and capabilities allow. In doing so, we are truly transforming Walgreens into a trusted healthcare provider to our customers and patients. Within pharmacy, this includes pharmacists interacting and counseling patients in new ways. Whether taking an active role in diabetes care or other chronic conditions, Walgreens will continue to lead the way in introducing new programs to care for customers and patients.”