My Thoughts on Singulair and Suicide
Since all the Singulair news came out right before I left town, I’m moving today’s regular Weird Health feature to tomorrow next week.
Today, let’s talk Singulair.
First, a disclaimer. Talking about medication, side effects, and pharmaceutical companies can be about as explosive as talking about politics. What I’m writing here is my own take on the Singulair/suicide issue, and I know plenty of you may disagree. That’s as it should be. Just play nice if you comment, no matter what your views.
First, here’s the most recent statement on the FDA’s Singulair investigation, from the American Academy of Allergy Asthma & Immunology and the American College of Allergy, Asthma & Immunology:
Leadership from the American Academy of Allergy Asthma & Immunology and the American College of Allergy, Asthma & Immunology released the following statement in response to the Thursday announcement of a Food and Drug Administration investigation into Singulair:
There are no data from well-designed studies to indicate a link between Singulair and suicide. The concern expressed by the FDA is based entirely on case reports and there is no indication that such effects apply to other leukotriene-modifying medications.
Post-marketing case reports are incomplete. Furthermore, comparative data are lacking on the incidence of suicide in the general population versus the incidence in patients taking Singulair. Thus, it is unknown whether there is an increased incidence of suicide in patients receiving Singulair.
Based on the information currently available, patients taking Singulair should continue to take the medication as prescribed provided: 1) the patient and physician feel the medication is effective; and 2) the patient does not experience any suicidal behavior or thoughts.
Patients who experience suicidal thoughts or demonstrate suicidal behavior should consult their physician immediately to discuss whether to continue with this medication. Patients should not hesitate to consult their physician if they feel uncomfortable continuing on the medication. — March 31, 2008
Here’s the short version, with my own thoughts:
1. Patient reports, not clinical trials, noted some incidents of suicide.
2. There’s been no study of suicide rates in Singular patients vs. patients not taking Singulair.
3. That doesn’t mean there isn’t a link, but it doesn’t mean there is one, either.
4. The uncertainty caused the FDA to start an investigation.
Just about all medicines carry some sort of side effect and/or risk, and if FDA researchers determine Singulair does increase the risk of suicide and/or depression, probably not all patients would be susceptible. That’s true of most prescriptions, including asthma drugs as ubiquitous as albuterol. While it’s a literal lifesaver for most asthmatics, a small percentage flare even more when they use it.
Poking around the Internet and reading a couple of comments on last Saturday’s post shows me some parents/patients think Singulair should be taken off the market completely, that the risk is just too great.
Others have a problem with the way doctors have handed them Singulair prescriptions without warning of many–or any–side effects, especially ones so serious.
Because if we’re talking about suicide, even if any possible link ends up being a tiny one, we’re talking serious. And while Merck changed the labels on Singulair four times last year and early this year to reflect these possible side effects, it didn’t start talking about making sure doctors and patients are informed until February of this year.
Drug companies and doctors actually taking the time to warn and inform parents/patients of possible side effects? I think that’s a change we can all agree with. When I try to recall all the different medications AG’s taken for her asthma and related health issues, I can’t remember a single conversation with her doctors about side effects for any of the prescriptions, including oral steroids.
I’m guessing doctors figure we’ll read about the risks ourselves in the prescription information and we should, no question. But if we’ve already read the medication insert and no one told us the drug company has since revised it not once, but four times, just how do we know we’re supposed to read it again? I don’t know about you guys, but I don’t read reread the inserts every single time I refill AG’s prescriptions.
Why would I?
And here’s the real problem: when parents and patients don’t have enough information, they turn to the Internet to find someone else with the same problem. Anecdotal evidence, in other words, yet the medical community is reluctant to rely on anecdotal evidence! By reluctant I don’t mean, “My doctor won’t listen to this one story about my neighbor.” I’m talking about medical policy in general. Just take a look again at that statement above, that claims no clear link can be established without data “from well-designed studies.”
And every doctor in my life has always pointed to clinical trials rather than patient reports. For all I know, they may have to, by law. I don’t actually know if a physician can legally say, “Here’s this prescription, but please be aware some of my other patients have had problems with it.” What with patient confidentiality, malpractice, and all that.
But see, if drug companies aren’t going to be very, very vigilant about reporting updates and possible side effects to doctors and patients, and doctors aren’t just as vigilant about passing that information along to us if/when they do get it, then we’re going to turn to those anecdotes. And why shouldn’t we take other patients’ stories into account, when we’re making decisions about medicating our children? Yes, every patient is different, and what affects one person may not affect another the same way, but I sure like knowing how other parents feel about drugs I’m giving to my nine year-old kid. Especially if the clinical studies paint a clear picture of the possible side effects I can expect, but those anecdotes contribute to a whole landscape.
I could go on in more detail here, but I’ll just end up in an argument about the problems of profit-driven healthcare. And that one’s the mother of all touchy health subjects.
As for Singulair itself?
I won’t let my daughter take it, but that decision reaches back to 2003, well before any of this controversy. After a hospitalization for pneumonia and while struggling to find good control with her asthma, I filled her prescription for Singulair on the recommendation of a pediatrician. She was four years-old, and shortly after taking it her behavior did change. Normally a very even-tempered and accommodating kid, she started throwing tantrums and experiencing some mild mood swings and nightmares.
I remember, in particular, one night she woke up terrified, clawing at her arms and screaming, “There are spiders on me! SPIDERS ON ME!!” I noticed no depression and back then, no one was really talking about that anyway, but those side effects were enough, especially since Flovent alone started helping her enormously.
It was an easy decision. AG has intrinsic rather than allergic asthma, and Singular seems to help allergic asthma most. The question is, if she did have allergic asthma, and if Singulair had drastically reduced any allergen-induced flares, would the side effects have been worth the health benefits?
– Would her behavior have evened out over time, once her body adjusted to the new medicine?
– Or would her behavior have worsened?
– Could she have ended up depressed, even at age four?
While I’m lucky these are only hypothetical questions for me, if Singulair proves to increase suicidal thoughts and if that risk is small enough for Singulair to stay on the market, those are the questions patients and parents will have to ask themselves. Really, those are questions they’re probably asking themselves now. It’s pretty horrifying to think of our asthmatic kids as guinea pigs or in terms of risk-benefit analyses, but that’s sort of the nature of the beast, isn’t it? There’s no way to predict how a child without risk factors will react to a medication until she takes it. Asthmatics know if they’re aspirin-sensitive, for example, only after they swallow aspirin and then flare.
But parents especially need the most up-to-date, thorough drug information possible before they can make good decisions about medicating their kids. There has to be a bigger and better effort to warn patients about possible risks of all medications, but especially ones that may be linked to something as serious as suicide.
Instinct tells me Singulair is a good drug to keep around for some patients. I may not like how it affects my child—and I’m far from the only one—but at the same time AG has a younger cousin who takes it with no noticeable side effects. An adult male relative swears by it for his severe allergies, and messageboards are full of patients and parents on both sides.
But it’s not a perfect drug because there is no perfect drug.
Perfection would be not having asthma in the first place.