Pharmaceutical giant GlaxoSmithKline has said there is no evidence that its asthma drug Advair is linked with an increased risk of asthma-related death.
The firm made the statement in light of a 30-day deadline set by the US Food and Drug Administration (FDA) to agree on proposed changes to labelling for asthma drugs containing long-acting beta-agonists (LABAs) which have been linked with a worsening of asthma symptoms in adults and children.
GSK said no evidence had been found linking its flagship asthma treatment with an increased risk of asthma-related death or serious respiratory-related problems that require a hospital visit in the past ten years of patient use.
Dr Katharine Knobil, vice president for respiratory clinical research at GSK, said: “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.
“It is important that doctors have flexibility to make the proper clinical decisions to help patients gain and maintain optimal control of their asthma.”
Copyright Press Association 2010
US Food and Drug Administration