LABA drugs shouldn't be the first line of defense vs. asthma, the FDA says. Instead, they should be "added to the asthma treatment plan only if other medicines do not control asthma, including the use of low-or-medium dose corticosteroids."
But GlaxoSmithKline says the combination of LABA and inhaled corticosteroid drugs is an effective first-line treatment. The FDA's proposal would limit an asthma sufferer's choices "until after a patient has failed on other treatment options and therefore may be at risk for severe outcomes, such as exacerbations and potentially death," said Dr. Kathy Rickard, a respiratory medicine executive for GlaxoSmithKline, in a prepared statement.
"Sufficient safety information about these medicines is already in the labels to help guide physicians about their appropriate use," Rickard said. "However, we will work with FDA to address the differences of opinion about how best to communicate the benefit-risk profile of these medicines for optimal patient care."
Serevent's safety has been questioned by well-known drug industry critics -- Public Citizen and
Dr. David J. Graham
, a veteran FDA researcher. Graham told senators during a hearing last year on
now-wthidrawn arthritis drug Vioxx that several other marketed drugs needed more scrutiny or tougher labels. Serevent was one of those drugs.