I posted before regarding a study that suggested that montelukast...

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 <5 years old. In the SPC of montelukast, nightmares and sleep disorders as well as aggressiveness are labelled as scarce ADRs. Anxiety, the diagnosis in two ICSRs in the present study, is not labelled in the SPC. The number of paediatric patients being reported to experience these psychiatric symptoms in the present study is quite large and may thus be a signal, worthwhile to explore further. Additional studies are needed to confirm or contradict the signal. The ADRs reported during treatment with sympathomimetics were generally labelled in the SPC, thus known previously. The only reported ADR not specified in the SPC was an obsessive reaction, whereas anxiety in general is mentioned in the SPC. In hospitalized children, the overall incidence of ADRs has been reported to be 9.5% and in outpatient patients the corresponding figure was 1.5% [4]. Hence, the number of ICSR in the present study indicates that there is an under-reporting of ADRs not only in adults, as previously shown [13,14], but also in children. The frequency of under-reporting in children needs to be further explored. Furthermore, the present study only allows conclusions concerning the paediatric population <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 [4]. 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.