Fda investigation symptoms and conditions

I have not heard what the FDA's findings were regarding their recent investigation. I think it is an outrage that so many people have suffered from this drug. My 4 year old child too was a victim of this nasty drug. No child especially young children should have to suffer. My doctor had no clue as with the pharmacist that singulair changed their pamphlets. It just inferiorates me. Merck stated that they were committed to safety and had communicated that information of changing the pamplets. Funny how so many doctors missed that!

My eight year old daughter was recently diagnosed with precocious puberty. This is devastating to my family...She was on singulair fo asthma for almost 4 years...Noone in the med profession will comment on how this happened but the internet is filled with other parents dealing with the ame dilemma. I am so furious right now.

My 54-year-old fit, social, successful husband was put on Singulair in January for newly diagnosed asthma. He developed a depression with anxiety, irrational fears, avoidance, mood swings and even one episode of suicidal thoughts out of nowhere. He saw a psychiatrist and a therapist, tried medications, yoga, a vacation, meditation, breathing exercises - everything! But he kept getting worse.

The day he was throwing patio furniture then sobbing uncontrollably was the day he realized he couldn't work in his condition. He negotiated a 60-day leave without pay. Even that didn't help. It was crazy. How could a man who managed hundreds of employees and a major health service system for 20 years suddenly be so paralyzed with fear that he couldn't walk down a beach or go into a Walgreen’s?

We found this site May 26th. He stopped the Singulair immediately. It has been 10 days and he is already 80-90% back to normal. Thank God.

Partly I am writing because it is so hard to read of parents' guilt that they "should have known" etc. Look, unlike a child, my husband is mature and very verbal; he is also a psychiatrist (!) with a capacity for self-examination and a language to describe his inner experience. And me, I'm a psychologist (!) trained in understanding people and I know him very well. And yet with all that training and skill and consultation and treatment, WE STILL COULDN’T FIGURE THIS OUT! So please, don't make yourself feel any worse with guilt. This is awful and tragic enough already.

I would add that the onset of mood and behavioral problems is so insidious that it is hard to connect the problems to the Singulair. Also, I suspect that children and adolescents are at greater risk because of their immature emotional developmental level. An adult l suspect may need some genetic or personal predisposition to mood disturbance, or stress, or both, to trigger these side effects. My husband had a depression episode 30 years ago and had recent traumas that certainly could have triggered the depression. But how treatment resistant that depression was, and those strange paralyzing fears and extreme anxiety – all that I blame squarely on the Singulair.

I have made a report to the FDA. I urge you to do the same.

This is a follow-up. I have posted about our experience before, but to summarize: 6 year old boy on Singulair for over three years for Asthma. Drug worked wonders, but side effects developed so slowly that we thought those were "phases" that would go away. Side effects were just as everyone else reported: nightmares, fears, depression/sadness (we even went to a child psychologist since we thought this behavior was all due to father's deployment), aggressiveness, crying at the drop off a hat (like a 2 year old, not age appropriate), attention deficit, school performance dropped, and also, at the very end, obsessive compulsive behavior.
We stopped Singulair as soon as we heard about the FDA investigation (on NPR, about 6 to 7 weeks ago). Asthma has not worsened, thank goodness, so we make due with the Flovent for now. Most of the side effects were less prominent after some time, however the obsessive compulsive behavior stopped only a few days ago. We have better days, we have worse days, but slowly the better days outnumber the bad, aggressive, and negative ways.
What I read again and again in the postings is that we all assumed our children entered a bad "phase." A phase that just got worse and never ended!
Reading about the very same side effects in our children, over and over again, alarmed me. Taking my son off the Singulair and seeing the improvements, some faster some slower, totally convinced me. I will never ever have Singulair in my house again.

These posts about contacting a bad viral infection while the immune system is suppressed by Singulair are particularly worrisome. This was from 2007 so it has nothing to do with the FDA investigation. Epstein Barr causes some really bad illnesses including lymphoma.

The scary part is that children are the most susceptible to viruses. They need to develop immunity at a young age that will build up over time to levels that will protect them for the rest of their lives. Why are we giving children a drug that will suppress the leukotrienes? Why do we think that it is okay to take away one of the bodies defense mechanisms? Wouldn't it be logical that a drug that suppresses the immune system is a last resort option not handed out like lollipops?

www.iddb.org/drugs/singulair/ - 243k
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Anonymous Immune System Dysfunction September 13th, 2007

Do users of Singulair and Advair understand how these products work? In order to understand how they work, you must first know what happens in the body during an allergic attack.

Allergic response is a function of the body's immune system. When an allergen enters the body through the nose or the lungs (e.g., a bit of pollen or cat dander), it is recognized by the body as a foreign substance, and the immune system then produces histamines to fight the intruder. Singulair and Advair work by disabling the body's immune system, so that there is no allergic response.

I too thought these drugs were wonderful. I was on both Singulair and Advair to combat asthma from my new husband's cat. I took high strengths of these drugs for approximately three years.

During the time I was on these drugs, some disease entity, most likely a virus (e.g., Epstein-Barr, Herpes Simplex I, HTLV I). I have been sick with a fever for the last four and a half years. My immune system seems to have been permanently impaired, and every organ in my body is now compromised. I have a fever, night sweats, liver and spleen enlargement, digestive problems, skin infections, hypertension, rapid-onset insulin-dependent diabetes and other endocrino;ogical problems, blood cell abnormalities, and neurological problems (e.g., tremors, myoclonic seizures, muscle cramps and weakness, vertigo, incoordination).

I am about to undergo a spinal tap and other tests, looking for the causative entity. Whatever it is entered my nervous system when I had an epidural anesthetic while on these immune system depressants. I have not been the same since. I have been too sick to work. This has ruined my life.

As we have all learned from recent reports of heart damage from Vioxx, the FDA no longer has the money to fully test new drugs entering the market. The "clinical trials" are a drug's entry into the population. If it kills or sickens too many people, they withdraw it. However, the drug companies define "too many people" as a number that could potentially ruin profits through lawsuits.

MORAL OF THE STORY: Don't rely on the government to protect you. Before putting any drug into your body, do the research into how it works. Read comments from other users. I wish I had done that.

i don't need the fda investigation to tell me what this drug is capable of,i am so happy my son is off of it,the 3 year nightmare he lived is over,for that i thank god.He sleeps at night now,peacefully and soundly,he is no longer afraid to step outside,he can leave me and play with friends and not be afraid,he can go to school and learn,without letting his mind race in places no child should have to go.To all who knew of these side effects and chose to keep it quiet, shame shame shame on you.This drug poisoned and tortured and held captive in their minds the most precious and innocent victims.I am forever changed by this and will speak out loudly to all i meet

These stories sound all too familiar! What a nighmare this is for so many people. My son is 7 yrs. old and has been on Singulair for 5 YEARS! His dr. prescribed it for "cold induced asthma" which was a complication from RSV. Just about every time he got a cold he would develop pnemonia. The Singulair along with a nebulizer seemed to help his breathing. At first he was clingy. He wouldn't leave my side. We had to take him out of preschool because of it. Then, slowly his behaviors got really weird. He experienced severe anxiety, depression, self hatred, worried that me and his dad were going to die, sleeping problems, seperation anxiety, trouble focusing, stomach pain...etc. I too thought that I must be a horrible mother. My 9 yr. old isn't on any medication and he is a normal child. I thought I was doing something wrong with my youngest boy! My husband and I were seriously thinking about taking him for mental professional help. We have been to his dr. two seperate times to discuss his behavior problems and he basically blew us off! There are no side effects listed (from his prescription) that have anything to do with behavior problems. I always check the paper I get when I refill his prescription. I haven't given him this junk since March 28th as soon as I heard the news. Finally, all the pieces of the puzzle fit! I have seen improvement already! Last night he actually asked to go to bed. Before it was a terrible struggle to even suggest that he goes to bed. He did his homework tonight without any difficulty focusing!! That was awesome to watch! I hope he continues to get back to the sweet and happy boy he was a such a long time ago! He and his brother share a room and have bunk beds...right now I hear (for the first time in forever) him laughing with his big brother! Oh, what a beautiful sound!!!!!

My 9 year old son has been on Singulair for about four years for asthma and allergies. It did wonders for his asthma and allergies. However, since starting the medicine, has experienced rages, anger, impulse control problems, extreme mood swings, violent and destructive behavior, repetitive behaviors, bed wetting, weight gain, bad self thoughts, ADD, paranoia, peer social interaction problems...shall I go on? He sees a psychologist once a week for counseling and a psychiatrist periodically. He was diagnosed last year with major depressive disorder and mild ADD. He was placed on an antidepressant, an antipsychotic, and an ADD med. My big-hearted sweet boy gradually faded away. When I heard the news about the FDA investigation last week, I did some investigating myself. What I found was gut-wrenching! The Singulair went in the trash. This drug has stolen four precious years of my sons life and made the entire family suffer! We have been through hell. Only four days off the medication and he is already feeling better and looking like my happy boy again! We are slowly weaning him from his psych meds. I am full of hope now for him and his future and my family's weel-being but I am FURIOUS at Merke!!!