Long-term safety of Singulair?

Posted on: Thu, 03/09/2006 - 12:52am
anonymous's picture
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The allergist wants me, my 6 year old, and my 2 year old to go on Singulair. For me and my 6 year old, it would be to try to get our environmental allergies under better control. We're both already doing Zyrtec and steroid nasal sprays (Rhinocort for him and Flonase for me). The pediatrician wants my 2 year old to start Singulair in addition to Zyrtec and his steroid nasal spray (Nasonex) to try to get his chronic congestion under control. At 17 months, his skin testing was positive only for peanuts. We'll retest again this summer. None of us have asthma.

That's the background. My question is about the long-term safety of Singulair. Since it was FDA approved relatively recently ('98), I can't find any long-term studies looking at it. The longest study I found was 6 months. I searched here for Singulair and saw that several people have taken it for several years with no apparent problems (while some people got immediate side effects, they seem to be the minority). Does anyone know of any long-term issues with taking this medicine? Even if it hasn't been studied, does anyone have any theories why it might be questionable? Ever since the Elidel fiasco, I'm especially cautious. It's still in the back of my mind that perhaps my child tests so close to having an immune system deficiency due to using it. At the time, I was thrilled to have a non-steroid to use for his eczema. I had a young baby and was exhausted, so I didn't research it. I didn't realize that Elidel suppresses the immune system. I can't help but wonder if using it for a few months caused permanent damage to his immune system development. We haven't used it in over a year, so maybe it'll catch up at some point. Or, maybe the Elidel is unrelated.

I got side-tracked. I feel the need to be cautious before starting Singulair, and I'd appreciate any info. people have about it. Thanks!

Posted on: Thu, 03/09/2006 - 1:23am
TarynsDad's picture
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Joined: 02/14/2006 - 09:00

I dont know of any long term studies of singulair either, but I do know it helps my child a ton. She is 3.5 and has been taking singulair and Zyrtec daily for 1.5 years. She was on Zyrtec first and it was ok, but once she started on Singulair in addition to Zyrtec, her congestion changed from being constant to being occasional. So too me, it made a big diff and she showed no side effects....thats all I can offer.
Tim

Posted on: Thu, 03/09/2006 - 1:26am
Corvallis Mom's picture
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Joined: 05/22/2001 - 09:00

It [i]is[/i] a risk. But truth be told, if it prevents worse trouble (thinking lung damage from uncontrolled asthma or bone thinning from repeated steroid doses ) with known risks, then in my opinion it is worth the risk.
It acts as a leukotriene inhibitor, so the mechanism is WELL DEFINED. How it does what it does is known, in other words. There have not (as far as I know) been any big surprises as far as side effects go.
Elidel was another story. We never used it because given my research background, anything with an unknown mechanism of action "here, take this, it works really great... we just don't know how yet..." is inherently taking the same sorts of risks as illicit or unapproved drugs pose. JMO (but a fairly educated one given my occupation...) I might have felt differently if we had been desperate at that point in time... so don't beat yourself up over it. I don't know why the FDA ever approved it, frankly. (again, JMO)
Anyway, with all that said, we still don't use Singulair year-round. Only during pollen season when the rest isn't enough. (Zyrtec, nasonex, avoidance measures.)
Personally, if you can do immunotherapy to control other allergies, this will help reduce the number of medications you need anyway. That is the plan we are operating with.
I know of no long-term studies right now, but my daughter uses it too. I am not especially afraid of Singulair. As I said before, we were quite wary of Elidel.
[img]http://uumor.pair.com/nutalle2/peanutallergy/smile.gif[/img]
[This message has been edited by Corvallis Mom (edited March 09, 2006).]

Posted on: Thu, 03/09/2006 - 1:34am
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I'm like you; I worry about long-term consequences of taking medications. I've only read the pharmacist's information on it with the results of studies they put on there (sometimes they include it with our prescription and sometimes they don't, just consumer information). I was reassured by the fact that in animal studies, even large doses didn't cause cancer or birth defects. There weren't troubling human side effects, either. So we're going along with my DD taking it all the time for now. About Elidel, I just started using that myself this winter. My dr. & I discussed the cancer risk, and he said that the main risk is with the injected type which people with conditions like rheumatoid arthritis use. He said that if cancer should happen from using it topically, it would be obvious right at the spot where I used it. He uses it for his own little boy, and he says he wouldn't take that risk unless he was really comfortable that it was a very small one. I hope he's right. At this point, I'm willing to take the chance on myself because it's the only thing that has helped my persistant facial eczema. But I don't know that I'd dare with a child, either, knowing more about the risk. My sister is a pharmacy student, and I've asked her about these two medications, too, and she was not concerned about the Singulair based on what she looked up. Elidel was another story.

Posted on: Thu, 03/09/2006 - 6:53am
pgrubbs's picture
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Joined: 10/27/2003 - 09:00

We use singular, and have for almost 3 years. No problems. My allergist, however, has a different take on Elidel. She said she still uses it on her own children, and had several reasons why it was "black boxed" inappropriately. She said that it will be back soon. I don't plan to use it on my dds again, even though we only used it sporadically.

Posted on: Thu, 03/09/2006 - 9:42am
anonymous's picture
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Joined: 05/28/2009 - 16:42

My main concern about Elidel isn't that it might increase the risk of cancer. My main concern is that it suppresses the immune system.

Posted on: Thu, 03/09/2006 - 1:39pm
anonymous's picture
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Joined: 05/28/2009 - 16:42

Corvallis Mom, thanks so much for your post. You are a wonderful resource! You know so much about these issues (having said that, I appreciate everyone's input. You know what I mean, I hope).
Quote:Originally posted by Corvallis Mom:
[b] if it prevents worse trouble (thinking lung damage from uncontrolled asthma or bone thinning from repeated steroid doses ) with known risks, then in my opinion it is worth the risk.)[/b]
Are you referring to oral steroids? The doctors told me emphatically that steroid nasal sprays are nowhere near as harmful as oral steroids. They've said he might lose 1/4 inch in height, but that's the only long-term effect. I'm OK with his being 1/4 inch shorter. Are there other long-term issues with steroid nasal sprays that the doctors haven't mentioned? He doesn't have asthma, so I don't need to worry about oral steroids or damage to his lungs from asthma.
I read a bit about leukotrienes, but I have no medical background and a lot of it went over my head. Are there good leukotrienes? Do I need to worry about good stuff getting blocked by Singulair? If so, then I'll have to see if the pros outweigh the cons.
Quote:[b]we still don't use Singulair year-round. Only during pollen season when the rest isn't enough. (Zyrtec, nasonex, avoidance measures.)[/b]
Pollen and ragweed also are problems, but it's not just the seasonal allergies for us. We're dealing with allergies to mold, dust mites, and other things that are present all year round. If we're going to take Singulair, I would think that it would have to be year-round. Do you see additional problems from not having a break from it?
DS#1's congestion isn't terrible, but he keeps having a fluid problem in his ears. Fortunately, it doesn't seem to be getting infected. DS#2's issue is chronic congestion that often turns into sinus infections. Like I said, we don't know if he has seasonal allergies (tested negative at 17 months, will test again this summer). If you read my other post about him, you may remember that he has a borderline immune system deficiency (IgA of 31, which apparently is low but normal. IgM was 168 when normal is 166, but tested while he had a sinus infection and he'd had a normal IgM level at an earlier test). ENT suspects a structural problem in the sinuses, but we're not putting him through a CAT scan since he's only 2 and we wouldn't treat him any differently at this point. As for myself, I tested 4+ for numerous environmental allergens and symptoms aren't adequately controlled by Zyrtec. Most of the time I can tolerate it because I've got a good pain threshold, so I put up with a lot. However, sometimes it's been really bad (tight chest and a little difficulty breathing until walking outside someone's house with a dog, for example. Even then, some chest tightness and not totally normal breathing until I changed clothes and showered. Also, I get horrible sinus pressure whenever it's humid--- probably from increased mold).
[Quote] [B]Personally, if you can do immunotherapy to control other allergies, this will help reduce the number of medications you need anyway. That is the plan we are operating with.[B][Quote]
Does immunotherapy mean allergy shots? The allergist has been encouraging me to consider doing shots for me and DS#1. He's only 6, so I'm not sure I'm ready to deal with getting him weekly shots, espec. with having to sit in the office for so long with a 2 year old there, too. The drawbacks of the medicines may not be as bad as allergy shots for another year or two. I'll start doing allergy shots for myself whenever DS#1 starts his shots. It makes sense to do them together since we'll need to be in the office so much. I'm not set on this plan, but that's what I've been thinking until now.
Now you know practically our whole medical files! Thanks for your input. I highly value it.

Posted on: Thu, 03/09/2006 - 1:56pm
Corvallis Mom's picture
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Joined: 05/22/2001 - 09:00

I don't know what I would do if we couldn't control our dustmite exposure in other ways...
we are all allergic, though, so we really have to.
My point about Elidel wasn't that it isn't good at what it does. I'm just not surprised that unexpected side effects have emerged. My guess is that there will be more of them, given that the mechanism isn't well-defined. (Usually the FDA doesn't approve such things is all.)
Anyway, I personally would be more comfortable with Singulair long-term if it had been used a bit longer... but it seems to be very well-targeted and safe so far. As far as damping immune responses... I don't think anyone really knows exactly whether or not this is true. Leukotrienes are certainly involved in mounting an appropriate immune response, which is why damping them slightly in asthmatics isn't considered [i]bad[/i] since they are hyperreactive in this respect, generally.
For someone with borderline immune function, though, I'd want to talk to a genuine immunologist about it. Not even a garden-variety pharmacist or allergist is likely to understand what you are asking, I would bet.
Steroids... yes, I worry less than I used to about the sprays. But they wouldn't help the way that they do if there weren't [i]some[/i] systemic intake. I worry about bone density in my daughter a bit. Because you can't undo these years later with good habits. (shrug) But it doesn't matter if she doesn't live to see adulthood because of brittle asthma... so it's the lesser of evils for us, I guess. My concerns there are that they've only really studied long term use in adults. The jury is still out on how kids do on them if they start so young. Even the height thing is really a guess at this point-- a recent study suggests that they may not lose as much as originally feared.
I kind of take a minimalist approach to my personal pharmacology unless the benefit is pretty clear and the risk is either pretty minimal or clearly less awful than the benefit is good. (Hope [i]that[/i] makes sense.)
I highly encourage anyone whose doc thinks its a good idea to consider allergy shots for aeroallergens. ESPECIALLY perennial ones like dustmite or animal dander. DD started in September and we can already see a difference in the oral allergy syndrome with the birch pollen. Really. The shots have been nowhere near as bad as I feared/remembered. DH concurs. [img]http://uumor.pair.com/nutalle2/peanutallergy/smile.gif[/img]
And if you start them young, it isn't such a disruption w/r to school.
Thanks for the vote of confidence, BTW. [img]http://uumor.pair.com/nutalle2/peanutallergy/wink.gif[/img] (You know I'm not giving medical advice, right? Just another mom, but I am glad to help.)

Posted on: Thu, 03/09/2006 - 2:04pm
AlwaysAvoidAnaphylaxis's picture
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Joined: 06/23/2001 - 09:00

Bob Wood at Hopkins told me that Singulair was one of the safest meds for kids that exists out there.

Posted on: Fri, 03/17/2006 - 9:00am
monkey's picture
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Joined: 06/30/2005 - 09:00

We started our 2.75 year old on cingulair, he's been on it for nine months.
IT PROBABLY SAVED HIS LIFE. I was very leary of it the listed potential side effects are scarey. I have an adult friend who has tried cingulair twice and has immediate side effects, its a no go for her. Our son is on cingulair, zirtec, and zantac, and last night for the first time he ate a hamburger on a bun. A MAJOR MILESTONE, because he suffers from allergic esophagitis when the allergys are not kept at bay. to the point, I don't think our child can live and thrive without cingulair.

Posted on: Fri, 03/17/2006 - 1:32pm
Lori Jo's picture
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Joined: 09/17/2003 - 09:00

We used Elidel. Not alot, because it didn't seem to really help dd's eczema. Then she was put on Singulair, and it completely cleared her eczema. She would crack and bleed at her wrists and ankles. She's got scars from before it was controlled. Singulair has been the only thing that truly did the trick. It also helps her environmental allergies, much better than any antihistamine ever did. She is not so congested when she takes it. She's been on it for 2 years now.
Can you tell I'm a fan? [img]http://uumor.pair.com/nutalle2/peanutallergy/smile.gif[/img]
------------------
Lori Jo,
Rose, 7-31-02, PA
Beatrice & Georgia, 8-14-99

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