Dear Dr. K: I recently heard that the “black-box” warnings on LABAs (long-lasting bronchodilators) has been removed. Is that true, and are LABAs safe?
These are two great questions. The answer to both is “yes”. It’s best, however, that we explain a few things. The two most common of these bronchodilators are Formoterol and Salmeterol. They are basically long-acting forms of Albuterol. When they first became available about 20 years ago they could be used as a single agent to treat asthma. It soon became apparent this was not a good idea in moderate-to-severe asthmatics because they don’t treat the underlying inflammation that causes the asthma in the first place.
Until this was understood there were some asthmatics who were hospitalized or even died because of severe exacerbation of their asthma. This led the FDA to do two things: No. 1. To require the black-box labeling, and No. 2. To issue specific guidelines never to use LABAs by themselves, but only in combination with an inhaled steroid.
Once these guidelines were instituted, a number of academic studies have shown that these medications not only help control moderate and severe asthma, but also reduce hospitalizations and mortality.
It is for this reason that the FDA decided to do what is rarely done, and that is to remove the black-box warning. Their rationale for doing so is to eliminate patients’ fear of taking a medicine that could truly help (and not harm) them.