Letters Restoring Study 329

Paroxetine and Study 329: what we already knew and when

BMJ 2015; 351 doi: https://doi.org/10.1136/bmj.h5411 (Published 14 October 2015) Cite this as: BMJ 2015;351:h5411
  1. Larry D Sasich, pharmacist1
  1. 1Burlington, ON, Canada L7S 1Z5
  1. larry.sasich{at}gmail.com

The re-analysis of Study 329 using the Restoring Invisible and Abandoned Trials (RIAT) protocol missed crucial aspects of patient drug safety.1 2 3

The fact that paroxetine had not been shown to be safe and effective in paediatric patients was made publicly available on the Food and Drug Administration website in 1998,4 three years before the publication …

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