Clinical trial data symptoms and conditions

My allergies caused nearly constant painful sinus pressure, drippy nose (I should have bought stock in Kleenex to profit from my box-a-day use), asthma, getting gradually worse all the time--it was as though I'd had the flu for 10 years (I'm 54). I was taking Claritin in the morning and Zyrtec at night, which only toned down the most severe symptoms. I was on Prilosec as well, as one doctor though acid-reflux might exacerbate the asthma. My family and I are avid hikers, but I haven't been able to breathe well enough to join them for years, even with daily Ventolin and Flovent. I've only been taking Singulair for two weeks, but it has made all the difference. I feel "normal" instead of sick for the first time in a long time. So, for me, it does work. But my stomach's been killing me--like a bleeding ulcer (which I had 25 years ago). I'm hoping that will subside or going back on Prilosec (expensive!) will counteract it. I've also had the weirdest dreams--very vivid and disturbing. Because I did research online before taking Singulair (Doctor uttered not one syllable about side effects), I recognize the dreams are from the Singulair. Because I understand what is causing them, I can easily set them aside when I wake up. I think anyone who's had mental or emotion problems could be sent over the edge by the dreams unless they had a clear understanding and acceptance that the allergy drug caused them. I would be easy to think something was wrong with you to dream such bizarre, violent stuff. (I'd give examples, but I've truly trained myself to forget all about the dreams as soon as I wake us, so I don't remember the dream events now.) I'm quite concerned about children taking this drug. Maybe not everyone has this disturbing-dream side effect, but how could you explain them away to a four-year old? How would you even know if a younger child was having them? Even children old enough to comprehend shouldn't be subjected to horrific mental images, like the 16 year old above. A tip for people who Singulair helps, but they have the weird dreams--try Melatonin (over-the-counter supplement) at bedtime. I've used it to help me sleep in the past when life events kept my mind too active to sleep for several days at a time. Unlike sleeping pills, it doesn't make your tired the next day, you can wake up easily, and it's not habit-forming--it just lets you drift off on days you otherwise can't. Since I'm concerned about the long-term effects of anything taken frequently, I don't take Melatonin very often, but I did try it after the fourth day of Singulair dreams. I had no memory of weird dreams when I woke up, so it seemed to work, and I didn't remember dreaming the next night either. I only tried it that one day because, as I said, I've trained myself to not be bothered by the dreams.

Science has NOT conclusively ruled out a link between Singulair and suicide. In fact, science DID reveal a link between Singulair and depression (a risk factor for suicide). In the clinical trials one montelukast participant dropped out and the investigator cited the reason as depression that was "drug related". Additionally, in the primary and Phase II/BIII Studies, 12 out of 1955 participants taking montelukast reported depression, vs. 5 out of 1108 on placebo, and 1 out of 251 on beclomethasone. This information is presented in the FDA's medical review for Singulair and is available on the FDA website. Depression was not only reported post-marketing as some would like us to believe. As the FDA explained in their update to the investigation, Singulair's clinical trials were not designed to measure neuropsychiatric events so some may not have been reported. Using clinical trial data to prove that Singulair cannot cause a particular symptom or outcome is as foolish as discounting post-marketing reports that show that some neuropsychiatric events associated with Singulair are consistent with a drug-induced effect.

I am 34 years old. I am a pharmacy tech. I have asthma and allergies. I have taken singulair pretty much every day since it came out on the market. I've had asthma since i was about 10 years old. I took theophylline as a kid. Steriods on and off especially during times when my allergies are bad. I still use Advair during the fall and spring. Every drug has a side effect. However breathing is pretty good damn thing. Do I have days when I feel low? Yeah. Do I sometimes have nightmares? Yup. Are "natural" products the answer. Not always. The fish oil that some of the posters are touting can also cause GI problems. Some of the natural products contain herbs and other plant derivatives that can be harmful for a child that suffers from allergies. Not proactively treating asthma can be deadly. Some of the parents are suggesting steriods as the answer - those can cause weight gain, growth suppression and can lead to a worsening of asthma.

Singulair has never made me feel like I've wanted to kill myself. I was more depressed and angry as kid when my asthma did not allow me to partipate in normal childhood things. I was sad and hated life when I couldn't keep up with friends at recces because I was having trouble breathing. You have to outweigh the costs with the benefits. I am more irritable when I have asthma flareup then I am on a normal day. For me, I choose to breathe. And singulair has been helping me for almost a decade.

I'm not saying the medication isn't causing these symptoms but maybe there is an underlying cause to your child's depression.

Any drug has a side effect. But without medical research and the medications that come with them - people would still be dying of simple diseases and we wouldn't have vaccinations. As a society, as a whole, we are a culture that looks to someone else to fix things and then blames the people who try to fix it. We need to stop being the "hot McDonald's coffee'" society.

So the FDA spent 9 months studying clinical trial data that was not designed to monitor psychiatric events. That sounds productive.

That's like saying you're going to look for an orange in an apple orchard and spend 9 months doing it.

To clear up any misunderstanding about the FDA Singulair investigation.
FROM THE FDA STATEMENT ABOUT THE SINGULAIR INVESTIGATION

"FDA has not yet reached a definitive conclusion regarding the clinical trial data on mood and behavioral adverse events associated with montelukast, zafirlukast, and zileuton."

"although (the clinical trial) data do not suggest that montelukast, zafirlukast, or zileuton are associated with suicide or suicidal behavior, these clinical trials were not designed specifically to examine neuropsychiatric events. As a result, some events may not have been reported."

The FDA is continuing to investigate a link between Singulair and suicide .
They stated that they have not "closed the book on suicidality". Any news reports stating there is no conclusive link are incorrect.