Drug groups symptoms and conditions

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.

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.

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

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.

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.

I posted before regarding a study that suggested that montelukast should be studied for possible psychiatric adverse drug reactions in children. I could only find the abstract. I have now located the entire article. I originally thought the study was British but it was done in Sweden. I am going to make an e-mail file. If you would like the full text of this article to take to your doctor, I will send it to you.

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

BMC Clinical Pharmacology 2008, 8:1doi:10.1186/1472-6904-8-

Here is the discussion and conclusion.

Discussion
ICSRs were present in 19 of the 30 most commonly used drug groups in children. The number of ICSRs varied between the groups of drugs, the two most reported drug groups being the leukotriene receptor antagonists and centrally acting sympathomimetics. The reporting of new drugs should be expected to be larger compared with old drugs, according to the Swedish instructions concerning ADR reporting. The leukotriene receptor antagonist montelukast was registered in 1998. Consequently, no extra attention to ADRs during montelukast treatment was demanded in 2005. Centrally acting sympathomimetics, on the other hand, were introduced later and the number of ICSRs may be influenced by the increased focus on this drug group. Another explanation for increased reporting rates for certain drug groups may be media attention.

ADRs during treatment with montelukast seem to occur predominantly in small children, the majority in the present study being <15 years old, whereas children according to European Medicines Agency include 0 to 17 years.
In the present study, five percent of the ICSRs in children included serious ADRs. The corresponding figure for adults was 32%. With vaccine reports included, the proportion of serious ADRs has been reported to be 13% in children .

The design of the present study does not to allow conclusions concerning the question whether the number of ICSRs per million DDD differs between children and adults. Lower doses are often used in children, making direct comparisons difficult. Moreover, dose adjustments for children compared with DDD may vary depending on age of the child as well as the drug in question, making comparisons using DDD as denominator inconclusive. The number of ICSRs in the present study is quite small, implying that minor fluctuations in the number of reports can significantly affect the result. Hence, the disposition of ADRs in children needs further investigation.

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.

Artie commented below. I am posting Artie's comment back in a place where every one will see because I know the importance of arming yourself with research. I have worked for a major pharmaceutical company in my lifetime. I know that we need research and we need proof. Without that, we will be ignored.

Reply 1 minute ago on Apr 02, 2008 by artie81, #6536
Do you honestly think the people on this forum know how to interpret scholarly journal artcles?

Posted at 6:44 PM on Apr 02, 2008 by concernedcitizen, #29028
A British study suggests that Singulair should be studied for possible psychiatric adverse drugs reactions in children. I don't have this access to this journal so I have to try to find it. I will get back to you on what it says specifically. BMC Clin Pharmacol. 2008 Mar 17;8(1):1 Links Individual case safety reports in children in commonly used drug groups - signal detection.Brunlof G, Tukukino C, Wallerstedt SM. ABSTRACT: BACKGROUND: Due to few paediatric drug safety studies, knowledge on risks of drug treatment in children is limited. The knowledge needs to be increased to make proper risk-benefit analyses possible when treating paediatric patients with drugs. The aim of the present study was to investigate drug groups commonly used in children concerning type and frequency of individual case safety reports in children. METHODS: Number and type of individual case safety reports in the 30 groups of drugs (5th level ATC-code) most sold (number of defined daily doses) in outpatient treatment to children (<5 years old and experiencing psychiatric adverse drug reactions. CONCLUSION: The number of individual case safety reports per million defined daily doses varies in different groups of drugs. A possible signal for montelukast and psychiatric adverse drug reactions was found, which should be further explored. PMID: 18366638 The key sentence is: A POSSIBLE SIGNAL FOR MONTELUKAST (SINGULAIR) AND PSYCHIATRIC ADVERSE DRUG REACTIONS WAS FOUND, WHICH SHOULD BE FURTHER EXPLORED.

A British study suggests that Singulair should be studied for possible psychiatric adverse drugs reactions in children. I don't have this access to this journal so I have to try to find it. I will get back to you on what it says specifically.

BMC Clin Pharmacol. 2008 Mar 17;8(1):1 Links
Individual case safety reports in children in commonly used drug groups - signal detection.Brunlof G, Tukukino C, Wallerstedt SM.
ABSTRACT: BACKGROUND: Due to few paediatric drug safety studies, knowledge on risks of drug treatment in children is limited. The knowledge needs to be increased to make proper risk-benefit analyses possible when treating paediatric patients with drugs. The aim of the present study was to investigate drug groups commonly used in children concerning type and frequency of individual case safety reports in children. METHODS: Number and type of individual case safety reports in the 30 groups of drugs (5th level ATC-code) most sold (number of defined daily doses) in outpatient treatment to children (<5 years old and experiencing psychiatric adverse drug reactions. CONCLUSION: The number of individual case safety reports per million defined daily doses varies in different groups of drugs. A possible signal for montelukast and psychiatric adverse drug reactions was found, which should be further explored.

PMID: 18366638

The key sentence is:

A POSSIBLE SIGNAL FOR MONTELUKAST (SINGULAIR) AND PSYCHIATRIC ADVERSE DRUG REACTIONS WAS FOUND, WHICH SHOULD BE FURTHER EXPLORED.

I am Cody Millers mom ,the boy who died from Suicide while on Singulair for 17 days, I just wanted to say one thing to all of you that take the time to post.GO ONE STEP FURTHER CONTACT THE FDA and report to medwatch .The investigation needs evidence like your stories to help make informed decisions about this drug.The poorly orchestrated disclosing campaign that Merck had supposedly set out to accomplish in 2007, has obviously not reached the mass majority of people using this drug .Seeing now how many people did not make the connection to these HIDDEN AND DANGEROUS SIDE EFFECTS.Our child's pharmacy sheet that came with the medicine ,showed none of the updated side effects.They were added in April 2007,I filled the prescription in July 2007.Nothing had been disclosed until we put forth this effort to get the FDA's attention ,by asking the Senate and Congress to look into this matter.Go to your doctor and insist that they report YOUR SIDE EFFECTS to the company and the FDA.It is of the utmost importance.,Kate and Dave M.