Paxil (paroxetine hydrochloride hydrate)： Submission of a written request to receive information on post-marketing clinical trials of the antidepressant Paxil (tablets), carried out on children and adolescents.
2009-07-16
GlaxoSmithKline is currently conducting Paxil Post Marketing Pediatric Studies in Depression (Double-blind, Placebo Controlled Flexible Dose Study).
http://clinicaltrials.gov/ct2/show/NCT00812812
GSK has failed to prove the efficacy of Paxil in three pediatric studies. Furthermore, there is a possibility that Paxil causes violent or suicidal reactions. This result was confirmed in the Cochrane Database of Systematic Reviews.
Based on the above observations, we have strong doubts over the legitimacy of conducting this pediatric study in Japan.
On July 16th 2009, we asked Glaxo Smith Kline and the Ministry of Health, Labour and Welfare (MHLW) to disclose information on post-marketing clinical trials of the antidepressant Paxil (tablets), carried out on children and adolescents.
< Our Request Outline >
With regard to double-blind placebo controlled studies - clinical evaluations into the safety and effectiveness of Paxil (tablets) on major depression in children and adolescents, we wish to have the following information disclosed:
1. Evidence that the clinical trials were necessary and appropriate (reasons for any conclusions, and details on any studies made into the necessity and appropriateness of the trials).
2. In particular, if any effects on children in Japan had been anticipated as a basis for carrying out the trials, provide the evidence that this was based upon.
3. The current version of trial protocols (including records of past revised details)
4. Recruitment of examinees. (Number of examinees and explanations used at each facility, and the names of participating facilities up to the present time).
5. Information about adverse effects that have been reported until now (number of occurrences and the clinical course of individual cases).
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