Participant symptoms and conditions

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.

My 6 1/2 year old daughter has been on Singulair for 3 1/2 to 4 years now and we have had horrible experiences! She was having night terrors, mood swings, angry issues, self control issues, crying over small things, etc. We have been to psychiatrists and psychologists who have diagnosed her with mood disorder, sensory processing disorder and anxiety disorder! Well she has recently been having stomach problems so we have been going to a GI to figure that out. I got online to research and found numerous sites that told how Singulair causes all these things in children. We took my daughter off the meds and within 3 or 4 days seen a tremendous difference! She is a totally different child! It just really frustrates me and saddens me that all these children and their families are going through all this and the doctors do not seem to care. The allergist or psychiatrist didn't believe me. They say no study has ever proven such things. I don't care what they say we as parents know our children and we are the experts when it comes to seeing how they change when on this medicine, we are the ones that live with them and are with them everyday not the doctors! I think they just don't want to lose out on their money from prescribing this drug 90% of children with allergies and asthma!

Thanks for the update Kate,as we wait with interest in what Merck has to say,I hope it is not a repeat of the Lung Associations report.To review past clinical studies,i dont know feels crazy,to ignore post marketing reports,well ignorant.My fear is after making my report to the FDA,that was the end of it not one follow up for further information,not one question on how our recovery was continuing nothing.All my letters to my congressman not one reply,i did not ask for a reply,but if someone wrote to me as often as i write,i would at least want to rule out stalking.Clinical trials are what they are,they are for profit,and not the profit of the participant,but profit for the companies and clinics holding trials,this by itself is a conflict of interest.We must continue to demand change the very future of our children demands it.Those of us who have seen the ravages of this drug must still shout out till we are heard our experiences do count no matter what the out come of this investigation.Good luck to all keep fighting

Just read an FDA article out today, I believe. The FDA is looking to publish quarterly a list of "potential problem drugs". That is fantastic! But where will this information be posted, and how often should a medical prescriber visit and hunt for such information?

I still maintain every medical professional with the appropriate credentials to prescribe any medication should be required to register with an email address with a database within the FDA to immediately communicate this new-found quarterly list, as well as any investigations launched (as with Merck/Singulair). Wow - what a concept.

I suppose I should be somewhat more optimistic with a slight move in the right direction - but I know with all my heart neither my daughter's pediatrician, nor my personal intern will receive, nor be aware, of any of the quarterly "lists".

Will keep trying to get a change within the FDA.

My wife had Mirena inserted last year around May. Side effects were similar to those detailed here. Non-existent libido. Acne. Consistent with other's reports of joint pain, my wife experienced symptoms that were diagnosed and treated as Lyme disease. At the time we wondered how it could be Lyme disease when the doctor reported that several tests for Lyme disease came back negative. Now we wonder if the joint pain was actually the Mirena.

After reading the comments on this site, we had the Mirena removed in late May, despite a skeptical doctor. A week of uncomfortable heavy period, but not to bad. My wife's libido has returned, her face has cleared up, and I've gotten a vasectomy.

best wishes, Jim in VA