Update on the FDA and Long-Acting Beta-Agonists

I’ve posted before on the issue of LABAs and safety.  LABAs are medications that help keep the airways open fro 12 or so hours.  Both Advair and Symbicort have a LABA in them.  Concerns have been raised about the safety of LABAs, primarily based on flawed data from poorly done trials.  Nevertheless, the FDA has responded again to this issue, despite the fact that there is no new information on LABAs and safety.  The FDA is simply issuing another proclamation based on the same data that the last proclamation was based on.  Curious.  If the data is the same, I don’t see why the recommendations should be any different.

In fact, most of the recent recommendation from the FDA does not differ substantially from the previous one.  First, they reiterate that LABAs should not be used alone without using an inhaled corticosteroid at the same time.  (Both Advair and Symbicort contain an inhaled steroid in addition to a LABA.)  Second, they reiterate that LABAs should only be used in patients for whom other medications, usually simple inhaled steroids, have been ineffective.  Neither of these points is new or controversial.

They now recommend that children and adolescents using combination inhaled steroid/LABA therapy only be given devices which contain both.  That is they should not have a steroid inhaler and a LABA inhaler, but should use either Advair or Symbicort.  I don’t know for sure, but I’d guess that 99% of children or adolescents using combination therapy are already using a combination inhaler.

The point that is causing some controversy is this, and I’ll quote for accuracy, “ LABAs should be used for the shortest duration of time required to achieve control of asthma symptoms and discontinued, if possible, once asthma control is achieved. Patients should then be maintained on an asthma controller medication.” I think that this is a bad recommendation, and apparently so do some other asthma physicians. After yesterday’s press conference, some members of the American Thoracic Society asked for clarification on this statement.  The FDA’s response was much more tempered, “ The FDA’s intention is to encourage patients and providers to seek to reduce LABA use as much as possible if symptom control can be maintained without it. However, the FDA recognizes in some cases, discontinuation of LABA use, or even reduction of LABA use, may not be possible.”

I agree with the overriding principle of utilizing the minimum amount of medication needed to maintain adequate control, but the FDA’s recommendation does not follow this principle.  Rather it seems to say, “Wait til your patient gets sick, then add on more medication.  When they’re better stop til they get sick again and restart.”  Lather. Rinse. Repeat.  I would suggest that maintaining good control, preventing exacerbations, is a much better idea and if that means keeping the LABAs on board, then so be it.

I’m sure this won’t be the last of this issue.

Dr. O

Does Your Child Really Have Food Allergies?

Here’s a common scenario in my office:  A parent has taken their child to the primary care physician’s office to talk about possible allergies.  The physician sends off a “screening allergy panel” blood test which contains a few common airborne allergens like pollens, dust mites and cat dander.  The panel also contains tests for common foods like peanuts, milk, eggs, and soy.  A few of the food tests come back as positive and the parents are told their child has food allergies and needs to see an allergist.  The parents have heard horror stories about food allergy reactions and are scared stiff that their child may have one, even though he has always tolerated these foods in the past.  What do you do next?

Melinda Beck at the Wall Street Journal recently wrote an excellent article on this conundrum.  You can find it here. I highly recommend it.  It reiterates what allergists have been telling patients all along:  blood tests can be poor predictors of true food allergy.  A test is just a number, a patient is a person.  There’s a big difference.  In some studies, over 50% of kids tolerated foods they had been told to avoid.

These problems could largely be solved with a few simple steps.  First, and this is directed to the primary care physicians, STOP ORDERING FOOD ALLERGY TESTS INDISCRIMINATELY.  Sorry to all-caps and bold that, but I can’t stress this enough.  If the history does not suggest food allergy then there is no indication for ordering food allergy tests.  Simple rhinitis, sinusitis, otitis, and asthma are not food allergy related and foods have no place on a screening panel of allergy tests when evaluating these disorders.  To quote from Ms. Beck’s article, ““Are these blood tests being overused? Possibly. Misinterpreted? Absolutely,” says Robert Wood, director of Pediatric Allergy and Immunology at Johns Hopkins Hospital…”

Second, and this is directed at the labs running the tests: Stop putting foods in your screening allergy panels and stop marketing such panels to primary care docs.  This practice wastes money on needless tests and causes confusion and anxiety for countless families.  In short it is irresponsible.

Third, if you have questions about allergies, see you local board certified allergist.  In most cases a simple history will be enough to tell true food allergy from false positive blood tests.  Allergists have years of specialized training and experience in the proper selection and interpretation of allergy tests and the management and treatment of allergy problems.  They are best suited to help you solve these issues.