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my grand child is almost 3 year old , he has been on singulair candy for almost 6 month , what we noticed is a noticeable change in his behavior in the form of nervousness , he turned cranky , recently his teacher reported that he is not him as before , his appetite in that good as before , he became nagging while he was a sweet child before singulair .

The Health & disability commissioner in NZ has received my complaint of criminal negligence re my former doctor. They have now asked my former doctor for a please explain his version of events. The police have written to me saying they are seeking medical advice re criminal/negligence/failing to carry out professional duties complaint. Whilst I agree with everyone's feelings on big pharma, it is my very firm opinion that the doctor is the "retailer" and it is the doctor's direct responsibility to us the customer/patient to monitor and inform us of all safety concerns. Big pharma in covering their butts have warned the doctors to warn the patients. Of the 8 doctors including an anesthetist I have spoken with socially and in consultation, not a single doctor could name any adverse effects with statins beyond mild muscle pain. Given the warnings from pharma on the labels that is wholly shameful & negligent. An effective way to help others avoid being maimed like us, is to fight back from the bottom. The FDA and CARM in NZ take no notice, litigation is expensive and drawn out so neither really helps future innocent victims. I encourage everyone where negligence is fairly on the table to take your complaints to your country's police and medical discipline bodies enough of these complaints will soon have the doctor's "reading & obeying instructions" which would go a long way to preventing more tragic victims.

From the FDA's "Updated Information on Leukotriene Inhibitors: Montelukast (marketed as Singulair), Zafirlukast (marketed as Accolate), and Zileuton (marketed as Zyflo and Zyflo CR)"

6/12/2009

Neuropsychiatric events have been reported in some patients taking montelukast (Singulair), zafirlukast (Accolate), and zileuton (Zyflo and Zyflo CR). FDA has requested that manufacturers include a precaution in the drug prescribing information (drug labeling).

Montelukast is used to treat asthma, and the symptoms of allergic rhinitis (sneezing, stuffy nose, runny nose, itching of the nose), and to prevent exercise-induced asthma. Zafirlukast and zileuton are used to treat asthma.

The reported neuropsychiatric events include postmarket cases of agitation, aggression, anxiousness, dream abnormalities and hallucinations, depression, insomnia, irritability, restlessness, suicidal thinking and behavior (including suicide), and tremor.

This information reflects FDA’s current analysis of available data concerning this drug.

Advice to patients and healthcare professionals:

Patients and healthcare professionals should be aware of the potential for neuropsychiatric events with these medications.

Patients should talk with their healthcare providers if these events occur.

Healthcare professionals should consider discontinuing these medications if patients develop neuropsychiatric symptoms.

Background

In April 2009, FDA completed its review of neuropsychiatric events, (mood and behavioral changes) possibly related to drugs that act through the leukotriene pathway (montelukast, zafirlukast, zileuton). As part of its review, FDA reviewed post-marketing reports and also requested that manufacturers submit all available clinical trial data for these products.

The post-market reports of patients on these medications included cases of neuropsychiatric events. Some reports included clinical details consistent with a drug-induced effect. In the clinical trial data submitted by manufacturers, neuropsychiatric events were not commonly observed. However, the available data were limited because the trials were not designed to look for neuropsychiatric events. Sleep disorders (primarily insomnia) were reported more frequently with all three products compared to placebo.

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I am shocked and outraged at the "NEW" list of side effects that were attached to my newly refilled Singulair prescription. I am an adult and have been taking this medication for 3 years. I also know that I have not been happy in three years and every day I feel more and more hopeless and withdrawn. I have little interest in leaving my house, being with other people or anything else. Everything in life seems like an overwhelming task for me. I am filled with ideas about how to 'get away-far away'. I am a decent person, a wife and a mother of 3, but lately I would have done anything to be able to get a divorce and run. I have hated myself for these thoughts, which makes it all worse. I'm always reminding myself that these are people that I'm supposed to love! I ran out of my Singulair right before Thanksgiving and kept putting off refilling it, quite frankly, because I just didn't have the 'energy' to go to the store and pick it up. I did pick it up 2 days ago and that's when I noticed the new labels all over the bottle and was shocked when I read the description of the side effects. It was if they had been written about me. I have not taken any more of it and have now been off for more than a week and I feel like a human being again.

re: the post below. I have only recently experienced side effects of Yasmin...i am wondering is this anything to do with this new ruling on this other company prescribing Yasmin (maybe check your labels, which company are they from? ) Is this new company being able to get to make it cheaper) to prescribe Yasmin meaning they are messing with ingredients thus messing with our lives?????

Hi, I am a 57 year old female who was just recently put on Fosamax to counteract the bone loss caused by Femera that I am taking to keep my breast cancer from coming back. The first two weeks I felt okay albeit I did have stomach ache for two days and loose bowels. Then the bone pain began and I mean pain, not light, not moderate as the labels say, and it was especially severe at night. I found myself also feeling dizzy, depressed, no energy, kinda weird. I couldn't have relations with my husband because my hips and pelvis were so painful, also my neck, lower back and legs. Not fun. I took myself off it....Bone pain subsiding..also gastric upsets were getting worse. I tend toward gastritis and have IBS so this drug did not agree with me. I hate it! Will not go on any of these again, as I have also had lots of jaw problems in the past, and dental problems and DO NOT WANT that horrible jaw thing to happen. Yike... Love Pam

Our son started taking Singulair when he was 2 for severe allergic rhinitis and cough variant asthma (in addition to Zyrtec, which didn’t control all of his symptoms). He is 5 now. For the last three years, he has been an increasingly violent, difficult, defiant, argumentative, volatile child who has intense mood swings--one minute he’s laughing uncontrollably, the next he’s weeping over nothing. His doctor and therapist recommended that we see a psychiatrist to have him evaluated for bipolar disorder, which used to be unknown in children. Because he has such chronic sleep problems, the doctor also suggested we take him off Singulair (and increase his Zyrtec dose) to see if it improved his sleep issues. Within a week, he was sleeping much better and was a calmer, happier, gentler boy. He suddenly could take “no” for an answer without flipping out and trying to hurt me. We thought that we were just in an unusual, calm window that would shift either to mania or intense sadness or both, any minute. We also thought that his behavior change might be due to sleeping better. We were enjoying the rare reprieve. Over the last weekend, his springtime allergies really flared up. We gave him Singulair on Monday and by noon, he was completely out of control. I had to strap him into his car seat at one point to keep him from hurting either me or himself. It finally occurred to me that Singulair might be causing his “bipolar” disorder. Of course, we stopped the Singulair. After two days he was a new boy. Yesterday, I Googled “Singulair bipolar children” and got a few hits. I am stunned to read how similar other families’ experiences have been to ours and I feel sick that we gave this drug to our child for three years.

WOW! This is simply amazing. Every story I read is like someone is writing about my life. I am a single parent of a beautiful 7 yr old. My daughter has been on Singulair for 5 yrs. Like most she has the nightmares, mood swings, anger, endless energy, talks of death and dying. It is a very hard thing to watch your child go through this. It is horrible to have your 7 yr old tell you to just kill them. I couldn't tell you how many nights I have went to bed in tears after a day on this roller coaster of emotions. Like many other she has been LABELED as an ADHD & ODD child. For the past 2 yrs we have been fighting the battle of the diagnosis of ADHD and ODD and her ped is now saying possibly Bi-Polar. We are now trying a 4th med for the SUPPOSED ADHD since none have seemed to help and some have made it even worse. We have had countless appointments with doctors, counselors, and school about her behavior problems. Not to mention the amount of time at work I have missed. Now her ped has suggested a psychiatrist for the possible diagnosis of Bi-Polar. Well to my surprise all of this may be a side effect of a med that has worked so well for her asthma and allergies. I will be calling her specialist first thing Monday morning and see what options we have because she is getting off of Singulair. I am torn here....part of me is so angry that this med could be what has caused all this pain that my daughter and I have went through BUT part of me will be very happy to know that all these LABELS that my daughter has already gotten from her docs and at school will be wrong. It will be a great relief to know that this could all be over soon.

Behavioral changes started when my son was 3 years old and on Singulair, 4mg chewables. He became more angry, irritable, and even stated a few times that he wished he were dead. He has had trouble concentrating and has frequent nightmares.

My daughter is 5 years old and has been on singulair for 1 week. i have already noticed a dramatic change in her behavior. she has become irritable, mean, nasty, and emotional. she has had me in tears on a daily basis. she has turned into a monster. we will be calling the doctor in the morning!

I just had surgery and they prescribed Levaquin 500mg. I have just started taken three days ago. My legs has sharp pains as well as my achilles. I have had numbness in my arms and hands. Also, minor confusion and comprehension. I DID NOT know all of this. The side effects on the labels does not say all these side effects on this bored. Now, I am worried after reading all of this. I am not putting another pill in my mouth. My doctor did not say " stop taking this at the sign of ..." This sounds like poison rather than a cure.

I've taken Vicodin 500mgx3 or less if needed for 7 yrs. I truly advise to follow the labels that are on the bottle, if food..take it w/food, if H2o...take it w/H20, I can't tell anyone how important this tiny label is. I have done just that for 7 yrs and the Vicodin has been working fine...believe me sometimes I run-out and get it 2 or 3 days later and I'm fine. I have 3 heri. disks in my back and scadica. I receive a complete ckup on my kidneys and liver which thank God are fine.....I drink about 10- 20 oz. of water a day to keep me clean and my urine is almost clear as H2o, doc says great!!

Been on Advair for 10 months, and have gained 20 lbs since then!! Also experience sharp head pains, foot & leg cramps, short term memory loss, irritability and mood swings, increased menstrual flow, slow healing of wounds, etc. Main concern is rapid weight gain! I went to my dr today to discuss...she claims to be unaware of any of these side effects being related to Advair....she can't imagine weight gain as Advair is a powder that goes into just the lungs. My mid section is where I have gained mostly. After reading all the boards on different websites, I am surprised to see how many are experiencing the same side effects with Advair, & I am convinced that it is the cause. I asked dr to prescribe something else, & she did...asmanex & serevent....haven't tried it yet...but I now read that asmanex is also linked to weight gain. I feel so frustrated that I can't rely on my dr for this, & feel like I have to fiure it all out on my own. I'm scared to continue with these meds but I need something to keep my mild asthma under control....everyday. Can anyone recommend anything to me? Should I switch to non-steroid? Any feedback on Singulaire somethin similar? Any information will be helpful. Thanks!

Mona

I am so glad to find your web site. My now 4 year old starting taking Singulair in January to help with his chronic ashtma. After a month or two I mentioned to my husband how crabby my son had become. He blew me off and said he's three what do you expect. Now in August I have had the worst few months of my life. My loving sweet child has turned into a monster. We were ready to go to counseling, anything to figure out what was wrong with him. He has always been a little strong-willed but you could a least talk things out with him. On Singulair he was horrible. I can't even explain the anger he had, the tantrums he would have. I called the allergists and told him I was taking he off the Singulair. That was about 3 weeks ago. I could tell within the first couple of days a change in him and now everyday he gets better and better. My sweet little boy is coming back. Thanks for sharing and making it easier for this mom to have verification that other people are dealing with this also. Remember parents read all the labels and remember that you know your child better than anyone.

Depression is the least of the side effects.....it gave me two blood clots in my lungs and I almost died I was only on it for 2 weeks when the symptoms started. The hospital had reported the Yasmin 28 to the FDA as the cause of my blood clots and I followed up with the FDA and found out the hospital did in fact file a report. I was not warned about my age (38) and the consiquence of being over 35 by either the Doctor or the packets of the birth control pills. The FDA confirms that all Yasmin sample packets or prescribed packets need to have warnings on the labels ...mine did not. I was in the hospital for 4 days and was off work for 9 months and after a year later I am still having lung problems. In fact I just went in today and they told me I have lung damage in both of my lungs from the clots. I am only 39 years old and have the rest of my life to be concerned about sore lungs and worry about the weather and if my lungs will hurt that day or not.

For anyone out there....go off Yasmin right away and if your over 35 go off all birth control pills....at least your man will have you alive...I know I should be dead right now.