I would like to respond to the statement issued by the FDA on February 18, 2010. First of all, let me summarize what the FDA said. They once again expressed concern about the safety of long acting beta-agonists (LABA). Specifically, they are concerned about the potential increased rate of hospitalization, intubation, and death with the use of LABAs. They recommended LABAs only be used in conjunction with an asthma "controller" and not alone. They recommend LABAs only be used in patients that cannot be controlled with just asthma controller medications alone. They recommended if LABAs are needed, they should be used for the shortest time possible, then discontinued if possible. Finally, they recommended that LABAs only be used in products where they are combined with an inhaled steroid medication in pediatric and adolescent patients. They cite three sources of data in regard to their concerns: The Salmeterol Multi-Center Research Trial (SMART), the Salmeterol Nationwide Surveillance Study (SNS) and a meta-analysis conducted by the FDA in 2008.
Let me start by saying I actually agree with some of their recommendations. I think LABA's should only be used in conjunction with an inhaled steroid. Further, I think it's a great idea only to use products in which both medications are combined rather than separate. However, I strongly disagree with their assertion that LABAs should only be used "for the shortest time possible" and that they should be "discontinued if possible" and left on just the controller medication. First of all, the FDA does not offer any data or evidence that the combination of LABAs and inhaled steroids present any danger at all. In fact, all the data that is currently available shows that the most commonly prescribed combination product, Advair, is not only safe, but far more effective in the treatment of asthma than any other product available. The three sources of data they cite shows a possible risk of LABAs when used without an inhaled steroid. This same data shows that Advair does not have this risk, and yet the FDA has gone ahead with its reckless recommendations.
The vast majority of physicians use Advair for their patients with asthma because it yields the best results. Why in the world would a physician change what has worked to something that may not work when there is no reasonable proof of danger? Advair has been available in the United States for over 10 years, and longer in Europe. It is the most widely prescribed controller medication for asthma in the United States and probably the world, with millions of users worldwide. Since its release, the death rate for asthma has gone down - not up. If there were a potential danger with a combination product like Advair, it would have become evident by now. Put another way, if combination products like Advair are so dangerous, then where are all the bodies? Obviously, there are no bodies - except for the ones that belong to happy, healthy, well controlled asthmatics.
I personally feel the FDA has become a bloated, worthless federal organization that succeeds in adding significantly to the expense of medications and little else. We would all be better off if the FDA were abolished. But that's just my opinion.
Michael Park, MD