Update on Asthma Drug Safety


There is some new data out on the safety of a couple of asthma drugs.  One, omalizumab or Xolair, isn’t very commonly prescribed, but can be an essential medication for certain asthmatics.  The others are salmeterol and formoterol- the long acting beta-agonists or LABAs.  I’ve written about the issue of LABA safety on numerous occasions.  It’s an important issue for many asthmatics.

Omalizumab is an injectable medication that is used for patients with severe allergic asthma.  In the right patient, it can be a life changing therapy.  Initial trials had suggested a very slight increase in the risk of malignancy, particularly skin cancer, for patients treated with omalizumab.  Now that the medication has be in use for a decade or so, there has been enough post-marketing surveillance to quell the concerns regarding malignancy.  A recent pooled analysis of randomized, double blinded studies shows no increased risk of malignancies of any kind in patients treated with omalizumab .

LABA containing inhalers continue to carry a black box warning.  As I have stated before, the FDA’s decision to place this warning was puzzling to physicians familiar with these medications and the voluminous literature surrounding their use.  In the April issue of Thorax, there is another critical review of the literature which comes to the same conclusion as other reviews:  when used concurrently with inhaled steroids (as all LABAs are in the U.S.), LABAs significantly reduce hospitalizations from asthma with no increased risk of life-threatening events or death.  The authors go on to chastise the FDA somewhat for giving recommendations that are confusing and that “do not appear to be fully evidence based”.  I agree.

Dr. O

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