Here is the FDA ordering release -- it doesn't cover COPD, but applies to asthma. FDA was forced to take this action, due to non-cooperation by some LABA manufacturers. No names were named by FDA.
This is a legacy Schering-Plough product line, and the issue has been simmering since February 2010 (as I reported back then), but these concerns go back more than a year and a half -- to December 2008 (my backgrounder linked):
. . . .The new updated labels [must] state:
Use of a LABA alone without use of a long-term asthma control medication, such as an inhaled corticosteroid, is contraindicated (absolutely advised against) in the treatment of asthma.
LABAs should not be used in patients whose asthma is adequately controlled on low or medium dose inhaled corticosteroids.
LABAs should only be used as additional therapy for patients with asthma who are currently taking but are not adequately controlled on a long-term asthma control medication, such as an inhaled corticosteroid.
Once asthma control is achieved and maintained, patients should be assessed at regular intervals and step down therapy should begin (e.g., discontinue LABA), if possible without loss of asthma control, and the patient should continue to be treated with a long-term asthma control medication, such as an inhaled corticosteroid.
Pediatric and adolescent patients who require the addition of a LABA to an inhaled corticosteroid should use a combination product containing both an inhaled corticosteroid and a LABA, to ensure adherence with both medications. . . .
"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, told Reuters. "Not all of the companies have accepted all the changes ... so that's where the ordering comes in. . . ."
Stay tuned, but this will not improve Foradil® sales in the US.
No comments:
Post a Comment