Milk Protein in Asthma Medications

I took my daughter to the allergist to find out about a daily asthma medication, because she is at the point of coughing every time she laughs too much, cries more than a little, or runs a few laps around the living room.  This is not good.  For a child at risk for anaphylaxis, she cannot afford to have her "baseline breathing" compromised.  If she were to have an accidental exposure/anaphylactic reaction, she would literally have less "breathing room".

The allergist prescribed a combined treatment plan of Flovent, Xopenex HFA (rescue) and Veramyst (nasal spray for allergic rhinitis).  

The only problem was, I opened the pharmacy bag with the Flovent Diskus box in it and right on the front of the package reads, "WITH LACTOSE"!  Um, excuse me?!  I open up the patient insert and it reads,

------------------------------ CONTRAINDICATIONS -----------------------
•Primary treatment of status asthmaticus or acute episodes of asthma requiring intensive measures. (4)
•Severe hypersensitivity to milk proteins. (4)

...and further down...

5.6 Hypersensitivity Reactions, Including Anaphylaxis
Hypersensitivity reactions, including anaphylaxis, angioedema, urticaria, and bronchospasm, may occur after administration of FLOVENT DISKUS. There have been reports of anaphylactic reactions in patients with severe milk protein allergy; therefore, patients with severe milk protein allergy should not take FLOVENT DISKUS [see Contraindications (4)]. 

Now, the seed was planted in my brain to look out for this, because I had read a Facebook post from a fellow blogger (please forgive me, as I cannot recall who it was - Allergic Child? The Eczema Company?) about unexpected sources of allergens in medications, so I can't say I was entirely surprised that an asthma medication contained lactose/milk ingredients, but I was flabbergasted that it had been prescribed to my milk allergic daughter!

I called the office back and told them that I could not use this medication and asked if they could find another one that did not contain lactose or any milk ingredients.  They told me they found one, but when I went to pick it up, it was a version of Pulmicort that also had lactose, so I sat in the waiting room and they brought me a sample of a medication called Qvar to take home and try.  The insert reads that it's for children ages 5 and up, and my daughter is only 4 years old, so my search is still underway for an appropriate medication.
(Update:  I spoke with both a friend who is a respiratory therapist and my daughter's pediatrician, and they both agree that Qvar would be safe and effective, even for a 4-year-old.)

Back to the milk protein issue, though.  Why would an allergist prescribe the Flovent Diskus to a milk allergic patient?  I went to do some research, and though I have not spoken directly with the allergist about this, it might be because she was convinced that it was not a great risk.  I must disagree, however.  My entire reason for going on this medication, was to strengthen my daughter's lungs, just in case she were to come in contact with a trace of her anaphylaxis risks (like, hmm, milk!).  It makes absolutely no sense to spin a dangerous "Wheel of Chance" every morning and every evening, with my daughter taking a puff of an inhaler filled with powder, laced with lactose, that just might possibly have enough milk protein (since the puffs are not uniform) to cause a reaction.

Here's a page from the American Academy of Allergy, Asthma & Immunology that I found on the subject:
http://www.aaaai.org/ask-the-expert/Lactose-in-asthma-inhalers.aspx

It's a long article, and at first it seems like they are downplaying the risks, but here is what I believe to be the pertinent part for those with severe milk allergies:  (my yellow highlights are added for emphasis)

Q: Some inhaled asthma medications (Pulmicort, Advair) contain small amounts of lactose and possibly small amounts of milk proteins. Is there a real danger here for milk-allergic patients, or does it seem to be more of a theoretical concern? Thank you very much.

       ...

For many years we had advised patients that "pharmaceutical grade" lactose was devoid of milk proteins. In retrospect, perhaps no one was looking because patients had not been reporting reactions. However, occasional reactions have been noted, for example in a severely milk-allergic asthmatic patient of the late Gail Shapiro, MD who used a dry powder inhaler containing lactose. Testing of various lactose-containing DPIs (Nowak-Wegrzyn et al JACI 2004) indeed disclosed presence of trace quantities of milk protein. The exact amount was not determined, but there is a notion that lot to lot variability exists. Additionally, the amount of lactose delivered varies by device (e.g., some routinely deliver more of the lactose carrier per inhalation). The package inserts of the DPIs are now typically commenting upon their containing milk protein (associated with the lactose carrier). The product insert I viewed online for the type mentioned here (Flexhaler) did mention milk protein in a parenthetical statement associated with "lactose". Of note, the allergic response would be directed to residual milk proteins (the lactose is derived from skim milk) and not to the milk sugar itself.

As with any food allergy, individuals may have a particular reaction threshold (for example, not everyone reacts to trace amounts). It is probably the case that the trace amount in the inhaler would not trigger a noticeable reaction for most with a milk allergy. However, it has been hypothesized that inhalation of a trace amount may be more likely to cause some reaction (e.g., the respiratory mucosal route having a more direct response and leading to asthma reactions) than if the same amount were eaten (affected by digestion).

We do not have a strong understanding of the extent of contamination in various lactose containing products. There is a study of a lactose containing soy formula where no milk-allergic children reacted and the investigators could not detect residual milk proteins (Fiocchi et al Pediatrics 2003).
As an aside, about 75% of children like the one described here tolerate a small amount of milk baked into a bakery product (e.g., cookies) even though they do not tolerate whole milk proteins (e.g., cheese, milk, yogurt) presumably because the bakery product has less protein and the heating in a airy environment further alters the allergens. Unfortunately, there is no easy way to know who may have this level of tolerance (no accurate skin or serum tests) and we have seen children have anaphylaxis to milk in baked goods.

Though this child described may qualify as one unlikely to react to the trace (if any) residual milk protein in the DPI (basing this assumption on the observation that he tolerated milk in baked goods), and certainly risk/benefit plays a part in decision-making, it seems reasonable to use an equally effective treatment without this additional concern. I am not aware of a DPI that has lactose and has been proven NOT to have potential milk contamination.

Scott H. Sicherer, MD
Associate Professor of Pediatrics
Jaffe Food Allergy Institute
Mount Sinai School of Medicine

Now, I must add that the decision to completely avoid lactose-containing asthma medications is based on my daughter's specific level of milk allergy.  She has a history of reactions to baked milk, so she's not one of those with a "mild milk allergy".  I understand that her anaphylaxis risk lies in the milk protein and not in the lactose, but they cannot guarantee me that there will not be traces and it would be too great a risk for her to possibly inhale a trace of one of her top allergens straight into her lungs.  The thought of it makes me dizzy.  

Sometimes, I think they don't pay as much attention, because it's a milk protein.  Imagine if a doctor prescribed an asthma inhaler that doesn't contain peanuts, but is made with an ingredient that just might contain trace amounts of peanut dust/protein.  Would they better understand my apprehension, then?  Would they see why I don't want my daughter taking her chances morning and night, breathing that in?

The bottom line is that you need to be ever-vigilant, even when something is prescribed to you by a physician.  Read every label on everything...check, check, and check, again.  We have to stay on top of things, because doctors are so busy these days and are many seem to be on auto-pilot, prescribing the same medications day-in, and day-out, without deep thought put into the fine details of the patient's history.  We are the ones who know our children's history best.  

As always, I share this information to help you in making your own decisions, but hey, don't even trust me!  You will always have to do your own research and look into yours/your child's specific medical needs and consult with a physician and use every resource you can gather to hopefully come up with just the right plan to keep everyone healthy and happy. :)    

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Edited to add:  Here is a story shared on Allergic Living's Facebook page, about peanut oil in ear drops.