Story Published:
Dec 11, 2008 at 4:22 PM CST
Story Updated:
Dec 11, 2008 at 5:48 PM CST
WASHINGTON, D.C. -- A panel of Food and Drug Administration advisors wants to take two drugs that treat asthma off the market. Foradil and Serevent are the two drugs in question. An FDA review shows the long-acting asthma medicines that reduce the use of inhalers also have an increased risk of hospitalization and death.
Julian Dorsey, 13, uses Advair, a similar drug, which the panel did not restrict. He says life isn’t easy without Advair.
Julian has severe asthma and, more than once, has almost died.
"If Julian is not on Advair, I'd lose my son," his mother said.
Dr. Shelly Salpeter of Stanford University School of Medicine
disagrees.
“Her child is at greater risk of dying if he's on that medication than if he's not," said Salpeter.
An FDA study presented to advisors on Thursday finds these types of drugs are two to seven times more likely than other asthma
medications to lead to severe complications, even death, especially in women, African-Americans, and children under age 12.
"It opens the airways, reduces symptoms, but alone, doesn't treat the underlying inflammation that drives symptoms" said Dr. David Lang of The Cleveland Clinic.
That's why doctors say these drugs must be used with inhaled cortico-steroids, which do treat the inflammation. In Symbicort and
Advair, the steroid is built in – and Advair was the only one of the
four with no increased risk.
Angel Waldron,from the Asthma and Allergy Foundation of America
believes removing the drugs or limiting access to them would be
setting us back about 15 years in asthma care. But there's
disagreement within the FDA.
One safety reviewer wants Serevent and Foradil off the market and all four long-acting asthma drugs banned for children. Another scientist told advisors that the benefits of these drugs far outweigh their risks. Manufacturers say when used with the steroid, these medicines save lives.
The overall numbers are small: of 60,000 patients studied, 20 suffered asthma-related deaths.