Swedish study symptoms and conditions

Clinical trial of montelukast in the Netherlands.

I noticed two things:

1. The researcher states that sides effects are 10%.
2. The researcher will not allow patients to also take drugs which are metabolized by CYP2C8 because montelukast inhibits that as proved by in vitro (test tube) studies. American studies in vitro said yes montelukast is an inhibitor but in vivo (in people) that it didn't happen. I was always confused by that and would still like to know more
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I am repeating one of my post regarding the Swedish study of the side effects of Singulair. When I read that parents have complained to their doctors about side effects and been dismissed, and told to continue the medication, I truly questions whether these doctors are giving their patients the right to INFORMED CONSENT.

I have been told by doctors before something like this "That is my professional opinion - I stand by it ." And I have said right back-- I understand that is your opinion. But if you don't have the time to tell me what I need to know then I am not giving you my informed consent. I get an entirely different attitude after that point. Because, that is how doctors get sued. Parents/patients didn't understand.

1. Have parents been told the complete reasons why it would be absolutely necessary, just necessary, or desirable to take Singulair and why?
2. Have parents been told what the alternative treatments are and the possible side effects of those treatments?
3. Have parents been given an option of another treatment when they complaint about the side effects of Singulair?
4. Do parents know that headache is a side effect that occurs in 18% of patients? These headache have indicated some serious events in European hospital reports. They are not just sinus headaches.
5. Do parents know that Singulair can cause serious events that require hospitalization as referenced in European hospital reports? These reports have described the event and provided laboratory test results that prove that Singulair was the cause.
6. Singulair in NOT an anti-histamine. Can your doctor fully explain to you how Singulair interacts with the receptors on the mast cell (cell part of the immune system)? Can your doctor fully explain how the mast cell will be changed by this? The mast cell has a number of receptors that interact with each other to tell the mast cell how to function normally; when it's time to die; when it's time to be replaced; and when to tell the bone marrow to send a replacement mast cell. Singular CHANGES the immune system---- good or bad???

So here is the report from Sweden to take to your doctors. Would your doctor give consent for his/her children after reading this? Maybe he/she would BUT at the very least that doctor would be looking for side effects that could mean trouble.

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Update: I have spent hours searching scientific data bases for articles on Singulair. So far this is the most direct reference to adverse drug reactions and Singular.

For anyone who wanted to print the article from the Swedish researchers that stated that their study suggested that montelukast (singulair) should be investigated for adverse psychiatric drug reactions, I was able to find a link with open access to the public. So far, this is the only article that I have found. I am still searching through databases. This link should work if you cut and past. I am sure that all doctors would appreciate the opportunity to read it for themselves to see what they think.

PRINT REPORT.

http://www.biomedcentral.com/1472-6904/8/1

Individual case safety reports in children in commonly used drug groups – signal detection Gertrud Brunlöf , Carina Tukukino and Susanna M Wallerstedt Department of Clinical Pharmacology and Regional Pharmacovigilance Centre, Sahlgrenska University Hospital, SE-413 45 Göteborg, Sweden author email corresponding author email BMC Clinical Pharmacology 2008, 8:1doi:10.1186/1472-6904-8-1 Conclusion In conclusion, the present study indicates that ADRs are reported for commonly used drugs in children. The number of ICSRs varies in different groups of drugs. A possible signal for montelukast and psychiatric adverse drug reactions was found, which should be further explored.

Please don't forget to PRINT the Tables which open on a separate page. Table 2 lists the specific side effects that they found which include anxiety, aggression, night mares, pain, and several others.

J. Douglas Bremner, M.D., I hope that you google your name and will give us your opinion. We are going in the right direction. We need expert help.

I would also like to point out a table that was in the Swedish study that showed what the adverse drug reactions were. It lists that children had night mares, aggressiveness, sleep disorder, abdominal pain, increased appetite, anxiety, fatique and several others. All of these symptoms are similar to what we are reading on this board.

This study was done in a foreign country before anything was ever announced in the American media. If you take this article to your doctor, please don't forget to print the tables. There is a link on the page.

See this link for the article.
http://www.biomedcentral.com/1472-6904/8/1

Individual case safety reports in children in commonly used drug groups – signal detection
Gertrud Brunlöf , Carina Tukukino and Susanna M Wallerstedt
Department of Clinical Pharmacology and Regional Pharmacovigilance Centre, Sahlgrenska University Hospital, SE-413 45 Göteborg, Sweden
author email corresponding author email
BMC Clinical Pharmacology 2008, 8:1doi:10.1186/1472-6904-8-1

Conclusion
In conclusion, the present study indicates that ADRs are reported for commonly used drugs in children. The number of ICSRs varies in different groups of drugs. A possible signal for montelukast and psychiatric adverse drug reactions was found, which should be further explored.

Table 2
Description of ICSRs for children in the ATC code R03DC. All ICSRs concerned the substance montelukast.

Age (years)
Dose (mg/day)
Treatment duration (when known)
ADR
SPC (Yes/No)

ADR, adverse drug reaction; ICSR, individual case safety report; SPC, summary of product characteristics
Brunlöf et al. BMC Clinical Pharmacology 2008 8:1 doi:10.1186/1472-6904-8-1