Singulair and population

What a night,6 months off singulair life was so good,until last night,a complete set back,insomnia night terrors, panic and anxiety all over again,could it be this drug causes flash backs,i am so frustrated and once again seething in anger at the suffering my son has endured ,and to think it may not be completely over devastes me.Any one else had reacurrances

Hey to All.
I know that the ALA study got everyone upset and I am happy we all emailed her.We all pretty much got the same response from Heather,defending the study and the integrity of the results.If only this investigation would conclude!
The Merck company contacted our Senator and indicated there was a conclusion and then ,they never got back to her before the weekend.I will have news early in the week.Please everyone just keep on voicing your concerns by reaching out any way you can.Sometimes it seems unbearable and I have to take a break with the communications on this website but,I continue my communication with my local contacts and the FDA.
I would love quick results and everyone would love this to get the publicity this story deserves but,if you look at how far we have come getting attention focused on this drug it is amazing.
This website has been here for years and people have complained and nothing has been accomplished until now.Our system is so broken it will take time to fix it.Drugs get approved everyday and when they are put out for multi use,the population benefit -risk ratio changes and there is little oversight on this matter.
The problem is much bigger than just notification of updated side effects,which indeed is why our son died from this drug.It is reporting adverse events to the FDA and the drug company and following up on your report.We can only fight within the system of the government that is in place at the moment and push for change to take place in there programs.
This is what has take place as of this year,The FDA's new 'Safe Use "iniative(which when it gets further developed will increase our partnerships with physicians as well as patients) and the July 2008 AAM report" Education in Safe and Effective Prescribing Practices" which aims to address the education of the next generation of physicians on how to best use medicines.This may help in notification practices and over prescribing but, we want the drug companies to lose the unprecedented control over the clinical research and and evaluation of there own drugs.What other company in the USA, gets to self regulate.Change will come ,we have asked for accountability by having a signature exchange when new and updated side effects are found.Full disclosure of all reported adverse events to doctors from the company representatives,with signature required upon full understanding of the benefit -risk ratio change. A prescriber should know all the good and the bad about a medicine they have chosen to dispense,if not then they should not be able to dispense it.If we were not knowledgeable about selling mushrooms and we sold the poisonous ones ,because we did not take the time it would take to educate ourselves about them,would we not be legally responsible for our actions.
Accountability is what we are asking for and maybe the candyland doctor prescribing practices would stop.They seem to ,not have a responsibility to their patients and the company has no responsibility to the prescribers,so who is responsible for our safety?
I will keep fighting for real change and all you people must do the same ,make an appointment with your representatives and have them contact our Congress representative of NY,maybe with enough onboard we can get the legislation we need to put a law in place for proper notification practices.Kirsten E. Gillibrand Member of the US House of Representatives 120 Cannon House Office Builing Washington, D.C. 20515
This is how change is made ,if you want to help please go forward and do this and don't stop until they listen.I am always willing to do whatever I can,it is physically exhausting and sometimes I just have to step away but, my daily review of this site has not stopped and my fight will continue.Dave and I sit here and our hearts just break for all but, we need people to push their Representatives they do work for the people just remind them of that.Any one with questions or that wants to communicate via private email just ask for my email address or phone number or leave me yours and a time and I will be sure to contact you,Kate M.

Hi everyone
My little boy who is nearly two was put on Singulair as a preventative.
I did check on forums when we started using Singulair and I was concerned that there has been descriptions of negative affects. Always trying to be objective I rationalised that the people in this forum are a small part of the greater Singulair population and as a result there was a low risk of negative affects on my little boy.
I have to say I think I was wrong. As soon as he was using Singulair, he had restless nights of sleep. Every night he would cry off and on until 2am and I guess he was so tired he slept. During the day he was very short tempered and became upset very easily. We put this down to tiredness. After 10 days of the lack of sleep for parents and little one, we told our doctor.
He advised to take him off Singulair for 5 days and make observations and then put him back on. Last night, his first night off Singulair was bliss. Not a sound. He had a great sleep. As I type he is now having another great sleep.
Let us see what happens after 3 more days and after putting him back on Singulair.
It would seem that if we are correct and that Singulair is a cause of an issue for my child, am I a quasi beta testing laboratory for a drug?
We are from Australia.
Thank you for reading.

I am finally writing after reading these posts since the end of April. That is when I took my 11 year old son off singulair, in an act of desperation. He has been on singulair on and off for about five years for seasonal allergies. He started again in mid-March so it could get into his system, before the allergies started. Immediately thereafter his behavior changed. He was arguing on a daily basis. He would hit, kick or trip me when he was angry. He was starting to destroy things in anger. He seemed to be fueled by anger. It was affecting the whole family. He was starting fights with his younger brother, my husband's heart was palpitating and I was crying every day. I heard about Singulair side effects and looked it up. I saw that it caused behavioral changes and out of desperation, took him off, not knowing what to expect. We had three days of total peace, then on the fourth day another outburst. Then my son told me he had taken a singulair the night before. That was it. I threw every pill in the garbage. He no longers acts like that. It's been almost two months so I am convinced it was the Singulair. By the way, he always complained of headaches, stomach aches and would scream in his sleep. Who knew - it was the singulair all along.

Below is the latest ADR report on Singulair from the United Kingdom. I deleted side effects reports by very small numbers of patients in order to keep the post briefer. This shows the total number of reports since Singulair was approved in the UK.

I don't know the total number of prescriptions for Singulair in the UK. It is considered expensive.

Drug Analysis Print
Drug name: MONTELUKAST
Drug name: MONTELUKAST Report type: Spontaneous
Report run date: 13-May-2008 Report origin: UNITED KINGDOM
Data lock date: 09-May-2008 08:00:02 PM Route of admin: ALL
Period covered: 01-Jul-1963 to 09-May-2008 Reporter type: ALL
Earliest reaction date: 01-Jan-1997 Reaction: ALL

Cardiac disorders-TOTAL 64
Palpitations 29
Myocardial infarction 6
Tachycardia 6
Diarrhoea 84
Dyspepsia 24
Abdominal pain 98
Abdominal pain upper 22
Nausea 84
Vomiting 52
Dry mouth 15
Asthenia 13
Fatigue 45
Malaise 32
Sudden death 1
Pyrexia 10
Chest discomfort 12
Feeling abnormal 16
Influenza like illness 17
Irritability 18
Drug interaction 13
Chest pain 13
Arthralgia 59
Myalgia 38
Muscle spasms 24
Pain in extremity 14
Balance disorder 10
Lethargy 16
Somnolence 23
Psychomotor hyperactivity 25
Headache 221
Dizziness 68
Neuropathy peripheral 7
Convulsion 6
Epilepsy 7
Dysgeusia 7
Hypoaesthesia 6
Tremor 18
Nervous system disorders TOTAL 526
Abnormal behaviour 13
Agitation 12
Anxiety 18
Aggression 30
Depression 23
Insomnia 58
Abnormal dreams 12
Nightmare 49
Hallucination 21
Sleep disorder 15
Psychiatric disorders TOTAL 364
Asthma 36
Allergic granulomatous angiitis 43
Angioedema 12
Swelling face 12
Erythema 13
Pruritus 32
Rash pruritic 17
Rash 55
Urticaria 33

TOTAL NUMBER OF REACTIONS 2841
TOTAL NUMBER OF FATAL ADR REPORTS* 19
TOTAL NUMBER OF ADR REPORTS* 1489

One additional comment: There is the possibility that because the drug has generally been prescribed the rate of incidence of suicide or attempted suicide has been minimal. The problem however is that drugs like Zyrtec (also producing similar side effects) have recently gone over-the-counter. There is always the possibility that as we see these types of drugs go over the counter - the rate of incidence will increase with the population self-medicating.

My daughter is 5 years old and has been on Singulair for the past 2 1/2 years for severe asthma. THANKFULLY, she has never experienced any of the side effects that your children or any of you have listed. She has never had any problems with it and we learned last year that it is something that she needs in order to keep her asthma under control. Last September, we decided to take her off the Singulair since she had not had an asthma flair up in almost a year and she was hospitalized 1 week later for a severe asthma attack. The reason why I am sharing this information is to let people know that these side effects do not happen to all of the patients that take this medicine BUT I DO AGREE THAT INFORMATION ON THESE DANGEROUS SIDE EFFECTS NEEDS TO BE SHARED WITH THE POPULATION THAT TAKES THIS MEDICATION! I want to thank everyone for sharing their stories of their experiences with this drug. I appreciate the information that I would probably never hear from a doctor or drug company, even though it is the most ETHICAL thing to do, especially when it has such a negative effect in children! Now I know what could possibly happen in my child and I will be more attentive and I know what to look for. I will be making an appointment with her doctor to see if there are other choices of medications that could keep her asthma under control and has less psychological side effects.