Long acting beta agonists and the FDA

According to this story, the FDA is considering taking long-acting beta agonists (LABAs) off the market because of a single study that showed increase risk of death in asthmatics who added one of them, salmeterol (marketed alone as Serevent and in combination with fluticasone, an inhaled steroid as Advair) increased asthma deaths. The increase was almost entirely among black patients and the majority of deaths occurred in those not taking inhaled steroids, which is contrary to current practice.

The second member of this class on the market, fomoterol (Foradil) has not been implicated in increasing deaths, but some worry that the increase deaths may be a "class effect" occurring with all LABAs.

Albuterol is a short-acting beta agonist and works by relaxing the airway smooth muscle and thereby improving air movement to and from the lungs (bronchodilation). LABAs have a similar effect but last longer (12+ hours) allowing patients with relatively bad asthma ongoing symptoms relief. They also seem to decrease severe exacerbations, but whether this is via their effect on smooth muscle or other, possibly anti-inflammatory actions, is not clear. Inhaled corticosteroids (ICS) such as fluticasone are the workhorse of asthma control and act by decreasing inflammation in the airway.

I think pulling Advair would be a huge mistake. It is a very effective medicine and greatly improves asthma control and quality of life in many pateints with asthma. In addition, because it combines an inhaled steroid and LABA it ensures that patients taking LABA are also taking ICS, which is a always a worry. The Glaxosmithkline reps (makers of Advair) claim there post-marketing data are reassuring re: deaths from patients on Advair, but it is probably a good idea to get that data in the public domain.

As an asthma specialist, I'd be happy to see Serevent (salmeterol alone) off the market as I don't think it has a role in asthma therapy, although it may be useful in treating COPD (chronic obstructive pulmonary disease). A combination of budesonide (another inhaled steroid) and fomoterol is in clincal trials and I think should be approved soon (both medicines are approved individually and the combination is bound to be safer since it forces patients to take their ICS).