The Wall Street Journal is suggesting that FDA has grown more concerned about the class of long acting asthma drugs -- especially when used by children. This class of drugs -- now under very-close FDA review (see the prodigious 460-page, 6.35 MB FDA Briefing PDF File on this matter) -- is called "long-acting beta-agonists", or LABAs. FDA has seen significant post-market-approval evidence that LABAs may actually increase a patient's risk of asthma-related death -- especially African-American children. Apparently the already-existing "black box" warnings on the products may not be enough. Nor, it seems, should they be. My bet is that these will no longer be approved for use in children under the age of 12.
Here's a snippet from the Journal's story -- but do go read it all:
. . . .The analysis was prepared for an [FDA] advisory committee meeting next week to discuss the safety of the drugs as a class. The panel will be asked to vote on whether the drugs should continue to be marketed for children and adults.
The FDA's new analysis of data submitted by manufacturers said there was a higher risk of asthma-related side effects among children ages 4 to 11 and among African-Americans. . . .
Overall, the agency said its analysis showed "that LABAs were associated with an increased risk of asthma-related events relative to non-LABA treatment as measured by the asthma composite endpoint consisting of asthma-related death, asthma-related intubation and asthma-related hospitalizations."
Looking at specific drugs, the FDA said the risk was seen with Foradil, Serevent and Symbicort "but was not apparent in Advair." [Editor's Note: GlaxoSmithKline makes Advair.] The agency also said the increased risk was not apparent when patients were also using inhaled corticosteroids, which current asthma treatment guidelines recommend.
The analysis involved 110 trials and 60,954 patients. The bulk of the patients were from Serevent trials, with about 43,000 patients, the agency said.
The agency said there were 20 asthma-related deaths in the studies and of those, 16 were patients on Serevent and four were patients in the non-LABA group. . . .