GSK response to paroxetine study 329 reanalysis

GSK responds to research group’s paroxetine study 329 reanalysis published in the BMJ

We were able to help this team to carry out their reanalysis by providing access to the detailed data from the original trial. This reflects our commitment to data transparency – we publish the results of all our studies regardless of whether they are positive or negative and we are the only pharmaceutical company to be part of the AllTrials campaign. We have also led the way in giving external researchers access to the very detailed patient-level data behind our studies, granting access to more than 50 research teams around the world so they can independently use our data in their research. 

Importantly, the findings from this team’s analysis appear to be in line with the longstanding view that there is an increased risk of suicidality in paediatric and adolescent patients given antidepressants like paroxetine. This is widely known and clear warnings have been in place on the product label for more than a decade. As such we don’t believe this reanalysis affects patient safety.

This particular trial, which was conducted in the 1990s, was included in detailed reviews carried out many years ago by regulators and by GSK which identified the increased risk. It’s something the medical community and regulators are aware of.

 Learn more about our commitment to data transparency.