The concern is over long acting beta agonists (some of these drugs are stand alone and some are combination meds with inhaled steroids). Beta agonists (bronchodilators) have long been watched due to concerns with tachyphylaxis which could lead a patient having an asthma exacerbation. This has been a well documented problem with salmeterol (the active ingredient in serevent and half of advair). The problem with the advair data (from the SMART study) as well as pot marketing surveillance is the inability to really separate out exacerbations due to tachyphylaxis from that due to the fact that GPs, who treat most asthma patients, do not follow the ATS algorithm for use of long acting beta agonists - in other words, the doc are not treating the patients’ asthma properly and, in way too many cases, are not prescribing the use of drugs containing a long acing beta agonist properly.

Formoterol (the active ingredient in foradil, oxis and 1/2 of symbicort) has the same black box warning as the salmeterol products, based on the assumption of class effect, but tachyphlaxis isn’t really a major problem for formoterol. The biggest problem with Foradil (novartis’ product) is the crappy delivery device and capsules - of course, the device is soooooooooooo bad, docs really don’t like to prescribe it (and patients don’t like to use it).

Is it really necessary? Is this overkill for this category?