Thanks flindy.
I too received the form response from the ALA - for what its worth I responded with the below:
hank you for responding so quickly.
My concern with the report is very specifically addressing the patient size of the study.
"Of the 1,352 patients who participated in the double-blind, controlled studies, 569 of these patients had been randomly assigned to take montelukast. "
569 is a rather small percentile for a drug taken by literally MILLIONS of folks. Added to this fact is that as a LOOK BACK study, you're not really addressing those who have taken the drug for well over the 24 weeks.
My only interest in this matter connects to awareness. I personally never thought to discontinue it's use as it was very good at improving my lung function. But my doctors never thought to question its potential side effects, because of the stealth like nature of the patient information for the drug. To this day no one has contacted my General Practitioner who initially prescribed Singulair to me, as well as later attempts to treat the onset of anxiety and depression.
So, the headline and level of import given to this study will lead to a potentially dangerous ignorance about the potential side effects. I would believe that the severity of the side effects with Montelukast, especially in children, would merit a more recent and perhaps larger sample size of data to be added to your current findings before using a sweeping headline.
Thank you for taking the time to listen to my concerns.
Ditto on my reply from ALA as well. I have copied below my response to the verbatim response I am sure we are all getting.
Heather - thank you for your reply. Funny you suggest to contact our doctor for the best course of treatment - there within lies my largest problem. The doctors and pharmacists have not been made aware of the side effects added to Singulair since October of last year.
Not your problem, I realize. But had Merck been liable (by the FDA, of course) to communicate the ongoing investigation for potential side effects, many of which are quite severe, my doctor would have not had this response to my question:
Question: What could make a 2 (or 3,4) year old scream so violently during the night when they are surrounded in a loving home?
Answer: Well, perhaps when a child sees a spider during the day that scares them, this can come to them during their dreams. I thought to myself, no really, you need to come hear the screams.
Point being, had she been made aware of the BAD/VIVID dreams being added to Singulair she may have made a connection.
So, all I am really asking is, how can reviewing past clinical trial information be a basis for publicly releasing the statements recently? How do you and others turn a blind eye to all the additional information at your hands since the initial trials? Do you take into account any of the FDA warnings, investigations, or have access to MedWatch reporting system to review the numerous number of adverse reaction reports? The statement "gathered from single events reported by doctors" - do they not all count when the exact same adverse reactions are on report after report?
I, like others, have lost even more faith with the entire system and I will work to somehow make sure pharmaceutical companies are bound and liable to instantly communicate any information that comes after the original point of sale. I am confident if, after the original launch of Singulair, was later approved to "cure the blind", the pharm reps would have been beating down the doctor's doors to pass this information on for increased profits.
In short, I feel the ALA fell short in the entire process and has released a misleading and far from thorough statement, simply recounting the initial clinical trial information. So does Merck now get to delete the potential side effects from their label since the ALA does not see a connection with depression or emotional well being?
Thank you for your time - I hope to some day see the position of the ALA and affiliates reversed on this issue.
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