Qvar Systemic Side Effects - Increased IOP and Loss of Height - Anecdotal Experience

Hello! Long time, no blog! We're still in treatment with Dr. Li, and still floating around in Limbo-Land, having a list of foods that we could challenge, but never seeming to find the perfect time for it.

I wanted to write here to report our anecdotal experience regarding some side effects I've noticed with my daughter's almost-6-year-course of Qvar. 

This is a link to the Prescribing Information document for the new Qvar Redihaler. The content is sufficiently similar to that of the previous Qvar inhaler. The following is an excerpt from the "Warnings and Precautions" section. The highlighted items are the ones I believe we have experienced in connection with the use of Qvar:

The first side effect that I believe we encountered was the one relating to Qvar's effects on growth. The section is shown below:

I will concede that children with multiple food allergies can be shorter than their peers, due to the restrictions on their diet, but my daughter used to be on the higher end of the growth chart. One year, at my daughter's well-check, they noted that her height percentile dropped precipitously to the 26th percentile. They were concerned and requested a hand x-ray, but everything looked OK, so they essentially "shrugged" and didn't seem overly concerned. This drop in height prompted me to look back over her height measurements over the years, during her various visits to the doctor. I saw the fall in percentiles, and thought it might be her use of Qvar, but it wasn't until I recently decided to create a chart of her percentiles, with her Qvar start date noted, that the connection seemed rather striking.

I understand that "correlation does not equal causation" which is why I am noting that this is our anecdotal experience. My daughter's food allergy restrictions began in mid-2010 and you can see a temporary drop, but then a recovery, so it cannot all be laid at the feet of her food allergy restrictions. Since tapering down on her Qvar dosage, she has been gaining in height, but I do not have a percentile for comparison, at this time.

The next side effect I'd like to address is the one regarding Intraocular Pressure (IOP). This helpful page discusses "high eye pressure", a.k.a. "ocular hypertension" and explains that though not necessarily a problem, itself, it can be a risk factor for glaucoma and should be monitored. 

My daughter has been visiting the eye doctor for the past couple of years, getting regular check-ups, because she started having minor vision changes and was in need of minor correction/reading glasses. At her most recent annual visit in May 2018, they had her do a series of vision tests. I asked about the "glaucoma/eye pressure" test, because it had recently been the topic of discussion with a friend. The medical assistant said that they don't usually test IOP until children reach age 10, but she would do it, since my daughter did well with the other tests and was turning 10 within the year. (I would later go on to read that eye doctors avoid it in younger children, since they are prone to squirm and resist the device being so close to their eyes, etc.) 

We went in to see the eye doctor and I asked about the pressure readings and she said they were "19 and 20" and I asked if that was high and she noted that it was a little high, but she wasn't concerned. I am hardly ever comforted by a doctor's assurances that abnormal readings are "fine", so I went home to do some research. I found this article, which provides a formula for calculating a child's expected IOP for their age. I ran the calculations and came up with a rough estimate of just under 17. Both of those numbers were above 17, so I continued my research. The friend with whom I had previously discussed glaucoma mentioned a possible link to corticosteroids, so I got out the Qvar insert, again, and lo and behold:

When my daughter began using Qvar, all those years ago, I read the entire insert. At that time, she had not experienced any side effects, obviously, because there was no long-term use accumulated to cause them. I refilled that prescription over the years and re-read the inserts maybe a few times over the years, but I will admit I was on autopilot with refilling it. Reading that ocular hypertension was a known concern really bothered me, because I felt like I had told our eye doctor from the beginning that my daughter was on Qvar, yet she never mentioned that her eye pressure should be monitored. I know doctors cannot hold all of the prescribing information of every medication at the front of their minds, but I always thought one of the reasons they ask what medications you are taking, is to allow them to be aware of what things might be contributing to issues one is experiencing.

Despite my daughter's eye doctor's lack on concern, I called back and asked that her IOP be re-checked. Her next IOP checked showed her pressures were "20 and 24". The eye doctor finally seemed to acknowledge that something was up (literally) and we agreed to continue monitoring, and the next time around they climbed to "24 and 25". I spoke with my daughter's allergist about adjusting her dose, and was given the OK.

Additionally, our allergist was so struck by the changes in growth velocity and eye pressure that she asked if she could submit the information to the drug manufacturer. I agree, naturally, as I believe drug companies need to be made aware of these things. Even if we can't prove an iron-clad link, they can take the information into consideration, if they see multiple reports. Given that both side effects are listed in their prescribing information, it should not be shocking news to them.

During this time I was also wondering why her IOP readings were climbing, when we weren't on a different dosage, yet. One theory I have is that it was because of the switch to the new Redihaler. With the previous Qvar actuator, we always used a spacer, but I suspect that the full dose wasn't being fully delivered. The new Redihaler actuator does not require a spacer and seems to be very effective at delivering the proper dose. So, I think there was a combination of long-term use and full delivery of the dose, which would essentially be an increase.

We started lowering the dose gradually, and began to see a drop in IOP, as shown in the following chart:

The gray line shows the IOP that is to be expected by her age, and the other two lines are for her left and right eyes. We're holding at a low dose, even though we've been given the OK to taper off, completely, as it's cold season and we want to make sure to ease off of it slowly, to prevent any withdrawal issues.

It remains to be seen how her IOP will change over time, and if there are any additional issues that we haven't uncovered. We'll also continue to monitor her height. Luckily, her asthma status is good and she is a candidate to taper off of Qvar, but I know that is not the case for everyone. I am not suggesting that anyone discontinue any medication, as we're often having to make tough choices about how to balance the pros and cons of any treatment. 

This information is only shared to provide a "heads up" to those who might be taking ICS long-term, or those considering starting on them. As always, note that I am not a doctor or medical professional.

All Quiet on the Eastern Front

Mandarin Characters for "Tranquil"

Happy New Year! I feel like I've been "away" for ages. My daughter is now 9 and in a homeschooling Girl Scout troop, since last year, and things have been pretty busy! We were also hit by the viral hurricane that went all around the country, and were down for the count for a week or so. We're all better, now, thankfully.

We're still in treatment with Dr. Li, though I will say that being sick threw us off course for a while, and we're working on getting back into the full swing of things. We're nearing 4 years of treatment and it can be really hard to maintain the full set of protocol items, but we're doing the best we can. The pill-taking is a breeze, but the other protocol components can be hard to keep up when you're not feeling up to par. 

We have an in-person visit with Dr. Li set for late March and I'll be interested in talking about next-steps and having "where do we go from here?"-type discussions. I feel like we're in a place where quite a few food challenges are possible, but it always seems so hard to find the right time for them.

One thing we are working on, is introducing wheat into my daughter's diet. We're doing this slowly, with a special process for preparing the wheat, combined with some treatment elements (from Dr. Li's protocol), in the hopes of making it a smooth process. Wheat can be hard on anyone's stomach, especially for someone who has never had wheat as part of her diet.

I debated introducing wheat, back and forth, for years. The deciding factor ended up being that I felt it was good to have as an option, so we could try baked egg, some day. I know the science isn't definitive, but there are some studies showing that egg baked with wheat binds in the "wheat matrix" in a way that improves tolerability, versus egg baked into gluten-free flour. I know it's not "required" but I think it might be helpful. 

So far, she has had the specially-treated wheat twice, 3 days apart. There haven't been any obvious issues, but we will see how things go, over time, as wheat can sometimes cause delayed gastrointestinal symptoms. Luckily, I am not overly concerned about anaphylactic reactions, but I will certainly keep my senses on alert, as always, when introducing a new item. I feel that things are moving along, albeit slowly, but there isn't much to report at the moment, so it has been pretty "quiet" around here, allergy-wise, which is fine by me!

I hope 2018 treats everyone well, and is a nice "quiet" year for everyone. 

(Unless it's something good, in which case, make a lot of happy noise!)

♥

Sesame Challenge Passed!

My daughter had a sesame challenge on May 11th and she passed! I posted about it on a Facebook group, but just realized that I did not blog about it, here. :O It also felt surreal for her to pass the challenge, so I kept waiting to make sure it was "real" and so far, so good! 

Sesame has been on my list to challenge, for quite a while, and we finally got around to it. It can be so hard to find a time to plan one when you don't have other things going on, but I realized that I really need to get going on these, or it will take forever to get through them all.

Sesame fell into the category of "high IgE but no reaction history". Her IgE to sesame had been as high as 15, then was almost 3 before treatment and then dropped down and hovered in the high 1s, low 2s.

Back in 2015, we did skin prick tests (SPTs) for a few foods, including sesame and flax, and they came out positive, so we were told it wasn't time for a challenge, yet. As time passed, I felt that the SPTs were lagging indicators and I also felt that the IgE levels just weren't going to get to be negative. Treatment with Dr. Li's protocol seeks to regulate the immune system and after a while under treatment, standard IgE testing becomes less and less easy to read as an "up bad/down good" indicator. Though there is an expectation that IgE will fall over time, it may never get back to a pre-allergic level. There's a long story there, but for now, let's focus on the sesame challenge.

For the challenge, I made "tahini cookies" which are pretty much peanut butter cookies using the tahini (ground sesame seeds) in the place of peanut butter. I used the Kevala brand, as their tahini is made in a facility that only processes sesame seeds. I chose tahini, over sesame seeds, because I had read that people sometimes have delayed reactions, when the stomach breaks down the outer seed and gets to the protein. Even with as nervous a person as I can be, I wanted the highest-protein version, so I could be sure that any other forms would only be a lesser risk.

Throughout the challenge, my daughter didn't really have any major issues, thankfully. She sprouted this light pink spot she gets, sometimes. I can't even call it a hive, because it's so small and not raised and it vanished before I could even load my camera option on my phone. Somewhere into the second dose, though, I did see her shrug her right shoulder toward her ear and she was headed toward her ear with her "pinky" finger. I asked her not to touch her ear, but I got the sense it was a bit itchy. I took pictures of both ears and noticed that the right one was a bit pink (more so than really shows in the picture, but not bright red, either.) The funny thing is, when I had some of the same cookie batch the night before, I had an itchy right ear for a bit. :P Anyway, I told the doctor, and she decided to make the next "dose" a little bit smaller. The subsequent "doses" were all fine and her ear went back to normal, without intervention.

This ear turned a bit pink...

This ear was fine.

They had us wait 1 hour after the last dose, but said we could go after that, since it went so well. During the 1-hour waiting period, her cheeks were a little pink, but she was lying down, so tired from having gotten up early. The pinkness didn't last and I've seen the same pinkness on many days when we haven't done anything out of the ordinary.

One thing that did calm my nerves a bit, even though it's not definitive, was that she is negative to Ara h 1, which has 80% homology with Ses 1, one of the main sesame proteins. I told myself that it boded well for her challenge, but I also don't want anyone to fret if their child is Ara h 1 positive, when it comes to sesame. She eats plenty of legumes that are supposedly "botanically cross-reactive" with her other allergens, so it's all relative.

I'm happy to cross another food off the list and hope to narrow things down to just the "big ones". She also passed a home "challenge" of fish (Ian's fish sticks). Cod tested negative, always, but I was nervous about fish. The Ian's fish sticks are actually pollock, but it was still OK. She's also still happily eating pinto beans, which were positive on that SPT a couple of years back, so I still look at SPTs sideways. :Þ