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Cder foi symptoms and conditions

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50 Side Effects posted for cder foi

January 17th
2009
8:02 PM

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.

-- By ms76 | Reply | (1) replies | Private Message me

January 15th
2009
3:11 PM

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!

-- By abuckler | Reply | (4) replies | Private Message me


 

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