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I’ve been taking singulair for my asthma and allergies for the last 2 years.  For me it’s been the best allergy medicationsingulair I’ve taken. In those 2 years I’ve rarely used my inhaler and my allergies are well controlled. In fact the last time I went to my doctor for a routine med check up (he only gives 6 months refills) he asked about my inhaler.  I told him it’s rarely use it. Singulair has certainly had a positive effect on my life and I know others who say the same thing. That’s why I was so surprised when this report came out a few days ago.

FDA is investigating a possible association between the use of Singulair and behavior/mood changes, suicidality (suicidal thinking and behavior) and suicide.  Singulair is a medicine in the drug class known as leukotriene receptor antagonists.  Singulair is used to treat asthma and the symptoms of allergic rhinitis (sneezing, stuffy nose, runny nose, itching of the nose) and to prevent exercise-induced asthma.

It will be interesting to see what the FDA does conclude  from this  possible association.  In the meantime anyone who does take this medication and notices a change in their mood or behavior should contact their physician or primary health care provider for evaluation.

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19 Responses to “FDA investigating Singulair”

  1. Martin Welch says:

    I think proper and thorough investigation regarding the effect should be done accordingly and immediately. Thanks for sharing about this interesting and shocking information. :D

  2. Kirk M says:

    I agree this should be investigated however, like most things of this nature, self monitoring is the key. If you’ve taken the medication on a long term basis and not experienced any of the behavioral changes they mention, then you’re probably safe I’d say. Of course that goes without saying in present company. :D

    On a personal note, I never agreed in yanking effective medication off the shelves because on gong studies showed that 1 in 500,000 (whatever) had (severe) adverse reactions to it. If that was the case then you might as well yank just about all of them. If you think that sounds cold, read the back just about any “off the shelf” medication for allergies, colds, flu’s etc and then look up the possible side effects and adverse reactions of any prescriptions you might be taking. The descriptions can be pretty scary.

    One of the most effective allergy meds that I could actually take and still remain functional (oversensitive to meds) was “Alka Seltzer Plus Allergy Medicine”. If I had a massive attack (hay, horse sweat that kind of thing), it stopped it cold within 10 minutes. It was a great preventive also for the times I knew I’d be working in environments that would cause an attack. Then they yanked that from the shelves along with other effective meds due to the possibility of adverse reactions in pregnant women. I more than understand this but are people so blind that they couldn’t adhere to a bright yellow notice across the back of the box that might state: “Not too be taken if you’re pregnant?”

    Or Perhaps I’m out of line here?

    Let’s hope they don’t pull Singulair for the same type of reason. The biggest problem with studies like these is the “knee-jerk” reaction afterwords.

  3. Elaine says:

    Martin – guess we’ll ‘wait and see’ what the FDA determines. Thanks for stopping in :-)
    Kirk – if you’ve noticed anything about this blog you’ll notice I rarely if ever post any of these type posts concerning medications because there is that knee jerk reaction as you said. Obviously I have NO problems with this medication and it’s been a lifesaver for me. I would hate to see it pulled from the market. Yet people want 100% safe medication and there isn’t such a thing. And that leads into these massive lawsuits against pharmaceutical companies (don’t even get me going on that topic) and more investigations by the FDA, more warnings, etc. It’s turned into a vicious circle.

  4. Keli says:

    Every medication has the potential of having a harmful side effect. In fact, some are downright comical! I forget which one, but there is a drug advertised on TV where a side effect is a sudden impulse to go gambling! Anyway, I hope the particular med that you mention passes the litmus test.

  5. Jen says:

    My son is 5 years old and was diagnosed with asthma in early September of 2007. His pediatrician immediately put him on Singulair. I would say that within a month my son became a different person. He would have these outbursts that were not caused by anything. He started saying horrible things to his siblings, his father, and myself. His behavior was just completely abnormal. He started having anxiety attacks and he had never had one before. In February 2008 these rages and outburst became awful. I would have to hold him down if he got upset because he would hurt himself, or try to hurt me. He would always return back to normal within 15 minutes as if nothing happened. He would always say “I don’t know why I did that.” He then had a fit (over nothing) and started saying he wanted to kill himself, he just wanted to die, he didn’t like the feeling in his body. This fit went on for about 45 minutes, and I could not calm him down. He’s 5 years old and was threatening to kill himself because of this feeling in him. The next night he had the same fit only this time he wanted to kill his sister. We immediately contacted his pediatrician and multiple physiologists because something was seriously wrong. About a week later and multiple rages we had scheduled a physiological evaluation which was going to run us about $850 out of pocket. My husband did a search for Singulair and found a message board where mothers were talking about the effects of Singulair on their children, and I felt as if I were reading something I had written. I called the pediatrician and told her that we were taking him off Singulair immediately. I also called the school nurse, and the psychologists we were dealing with, and none of them knew about these side effects of Singulair. They were ready to diagnose him with Autism or ADHD. It’s now almost 4 weeks later and my son is back to normal. He does not have that blank stare in his eyes, he focuses completely on the task at hand, but more importantly he has not mentioned killing himself again, no more rages. He loves all of us again and says “that feeling” has gone away. That was the most excruciating, heart wrenching thing I’ve ever gone through, and this drug really needs to be taken off the market. Think about all the poor parents out there going through the same thing as me and not knowing what is causing it. I hate to think if my son were a bit older and actually knew what killing himself meant, what would have happened then. This should have been taken off the market in 2007 when the teenager in NY killed himself 2 weeks after being on Singulair.

    He had no preexisting conditions besides the asthma. Back in 2004 the doctors thought he had allergies so they put him on Singulair for that for about 6 months. He was a completely normal child before the Singulair. It turned him into an evil child who was tormented daily by the effects of Singulair.

    Here’s a quote from Merck’s site “Merck voluntarily updated the worldwide product label for SINGULAIR in October 2007 to include “suicidal thinking and behavior” and included similar changes to the patient product information”. So if they voluntarily updated their information, why aren’t doctors aware, why is the public not privy to this information?

    Check this site out, you’ll be shocked to see how many thousands of children/people have the detrimental side effects of this drug.
    http://www.medications.com/se/singulair
    Mom of 3

  6. Janet says:

    I can understand everyone’s opinions here. It’s a hard call knowing what to do…. to be sure. Can’t help but think of the adverse side effects of Chantex that I experienced. Granted, it’s helped thousands of people quit smoking, but for those of us who had a horrible reaction, it’s frustrating to know that others will probably have to have experience the same thing. It reminds me of Russian Roulette. When it’s us or a loved one who gets the bullet, it’s a whole different feeling. But, yet… if these drugs are helping so many others, we certainly don’t want to take that away from anyone.

  7. Elaine says:

    Keli – I remember seeing that one too on TV but also forget which one, and thought to myself, “what an odd side effect”.
    Jen – what a horrible ordeal your son and family went through. My heart goes out to you. Thank God your husband found that website which lead you to the answers. I did click on the URL you left and was shocked to see how many children were affected by this medication. I echo your sentiments, “why isn’t the prescribing pediatrician aware of the possible side effects”?. At least if the parents were told straight up what to observe for the child could be taken off the singulair immediately and saved the child and family all this anguish. Thank you sharing your story and the link. Good luck to your little boy.
    Janet – You and I talked about this before your experience with Chantrix and I even told my brother to check out the message boards when he discussed with me, should he try it. Ultimately I think there will be more black warning labels on prescriptions and the doctors must make the patient aware when there are potentially life threatening mood/behavior altering side effects.

  8. Jen says:

    Janet, it’s funny you should mention Chantix, I started having massive heart attack like palpitations while on Chantix, and now will be on a beta blocker for the rest of my life. The doctors say it wasn’t due to chantix, but they started 3 weeks after I began. I stopped taking the med after one month hoping my palp’s would go away, but they never did, and it’s been a year and a half. If I miss a dose of Toporol my heart goes nuts.

    Elaine, thank you so much for your support. That’s all I want to see happen with this, is that doctors, pharmacists, parents, everyone should be educated for the sake of their childrens safety. What works with someone with no side effects, may not work at all with extreme side effects for another.
    Thank you again!

  9. asthma says:

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  10. It seemed to me that the percentage of people who felt this adverse affect was very small considering the number of people who actually take the med. Also it has been said to me that there is no rx that has absolutely nobody who experienced adverse affects. Not that I am discounting these people who have suffered from their use of Singular, but isn’t that why we stay in touch with our doctor.

  11. Jen says:

    How can you say “seemed to me that the percentage of people”, did you conduct a study? Did you go to the message board that I posted? The thousands of people that have posted there are most likely only a very small percent of those actually experiencing the side effects. Not everyone has internet connection, and not everyone is going to go post on one site.
    Yes we stayed in touch with our doctor, and he was almost diagnosed with Austism or ADHD because of the side effects of Singulair. Doctors were discounting these side effects because Merck had not the doctors or pharmacies know of these side effects. There are thousands of children that were put on the “fast track” by being put on Ritalin and other mood stabalizing drugs because of the side effects of Ritalin.

  12. Janet says:

    Jen ~ I read your post and sat here dumbfounded! That is exactly what happened to me! I don’t mean to be switching the subject from Singular to Chantex but I guess the subject could be meds in general and re-actions to them.

    But, anyway…. same thing here. Heart palpatations from Chantix so strong that I ended up in ER. Even though I stopped taking it immediately, my BP soared a few weeks later and I ended up in ER again. Before that, I always had excellent blood pressure readings. I’m on Toporal now too plus two other medications for hypertension. And this apparently will be for the rest of my life. Not to mention a lingering anxiety that always seems to be with me now.

    NZ Tourism – I, of course, was in touch with my doctor during all of this. As much as I pressed that Chantix had a potential to do more harm than good, he would counter-act with a statement of how so many are having excellent results and on the whole, it is a drug that is very well tolerated. Makes some of us feel like sacrificial lambs with these drugs. :-(

    Best of luck to you and your family Jen, and thanks for a very informative post, Elaine.

  13. thats scary…i can’t believe people use that stuff!

  14. Elaine says:

    Jen & Janet – absolutely unreal you both had such similar reactions from Chantrix! And Janet, I don’t mind at all switching the topic, like you said it’s still medications and the more people know (or hear) they can discuss with their doctor and make an informed decision. I thank you both for sharing YOUR stories.

  15. Laoch says:

    Usually once the Doctors find a drug which works well for me a study will emerge showing that it is bad for me.

  16. Elaine says:

    Concerning drug reactions and how they’re reported, I just read this on my home page and passing it along:
    Members of Congress called on the FDA Wednesday to move faster in forcing drug companies to include safety-reporting information in their television and radio ads.
    The lawmakers want “direct-to-consumer” advertisements crowding the airwaves during nightly news and other broadcasts to include information telling consumers how to report potential side effects to the FDA.
    The agency tracks so-called “adverse events” and uses reports from doctors and patients to tip them off to potential safety problems with drugs on the market. The system is voluntary, and agency scientists complain that it misses the vast majority of drug reactions that occur.
    “When only a fraction of adverse drug reactions are reported to the FDA, that means the system is failing,”

  17. Lisa says:

    My daughter has been on Singulair for the last few months for her asthma and allergies. I’m not sure if it’s really doing anything for her. I understand it’s very helpful for some; not so helpful in others. So far, we haven’t noticed any depression or anxiety caused by the medicine. I think almost any medication can cause a terrible side effect in a handful of people.

  18. W. Beth Young says:

    Elaine,

    I will become very depressed if they take it off the market. ;)

    OK…sorry…couldn’t resist.

    For me personally, it has worked beautifully, and without noticabe side effects. I have been taking it, along with , “Advair Discus”, and other allergy medications, and sinus sprays, for at least 5 years. Like yourself, my need for an inhaler has been reduced tremendously, along with visits to the emergency room, because of my breathing flow that couldn’t make it passed 250, with combination ear, nose, throat infections, and fevers, several times a year.

    Between the two medications that I have mentioned, and other helps, my quality of life has been improved tremendously!

  19. lotusflower says:

    All medications possess side effects. I am hypertensive and had elevated blood cholesterol. My Family physician prescribed an anti-cholesterol drug. She did that because my nephrologist was on an out of the country vacation during that time. Truth be told, I bought the medication on the way back, but when I got home I did some web research and was scared after reading possible side effects. I had them returned to the pharmacy. I refused to take the medication and opted to try food and lifestyle adjustments. I take my hypertension maintenance drug, that’s all. That was a year ago. And I am not sure if that was a good decision.

    My two cents worth of opinion says, we should be very careful about medications or drugs. I think the best judge of what we need is a trusted medical practitioner plus our common sense. Add thorough research to that.

    Cheers!

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