Date: 12/5/2008 2:54 PM
By RICARDO ALONSO-ZALDIVAR
Associated Press Writer
WASHINGTON (AP) — The blockbuster asthma drug Advair does not appear to have an increased risk of serious complications seen with similar new medicines, federal health officials said Friday.
But a less widely used medication, Serevent, had a significantly higher rate of serious complications, and even deaths, the Food and Drug Administration said. Both medicines are made by the same company, GlaxoSmithKline.
The FDA is concerned about asthma drugs known as LABAs, long-acting medications that relax tight muscles around stressed airways and free patients from the need to take a puff from their inhaler every few hours. For many asthma sufferers, that means they can sleep through the night.
But LABAs, for reasons that are still being debated, can increase risks of death and complications in some patients. The risk is lower when a LABA is used together with a steroid to treat underlying inflammation deep inside the airways.
Advair combines both kinds of medicine in one inhaler. But Serevent is a LABA-only product, although medical treatment guidelines call for patients taking the medication to also use a steroid.
The FDA analyzed reams of clinical data on four drugs: Advair, Foradil, Serevent and Symbicort. All four already carry strong warnings, but the findings could lead to more specific instructions for patients and greater restrictions on some of the medications. The agency has called a special meeting of outside advisers next week to discuss the data and make recommendations.
GlaxoSmithKline said the analysis underscored its confidence in Advair, its best-selling medication, with U.S. sales of $2.9 billion in the first nine months of this year. But a spokeswoman declined to comment on whether the data could lead to a withdrawal of Serevent, which had U.S. sales of $97 million in the same period. About 4 million U.S. patients now use the Glaxo medications.
Asthma is a chronic respiratory illness that leaves patients short of breath, wheezing, and can sometimes send them to the emergency room because of difficulty breathing. Some 22 million people in the United States suffer from asthma, and children account for nearly one out of every three patients. Nearly 3,600 people still die from asthma in this country each year, although symptoms can be controlled with medication to prevent the most serious complications.
Copyright 2008 The Associated Press.
