- “This is highly concerning because prescribing this drug may have put young patients at unnecessary risk from a treatment that was supposed to help them,” he says.
- “Although concerns had already been raised about Study 329, and the way it was reported, the data was not previously made available so researchers and clinicians weren’t able to identify all of the errors in the published report,” said Professor Jureidini in a statement. “It wasn’t until the data was made available for re-examination that it became apparent that paroxetine was linked to serious adverse reactions, with 11 of the patients taking paroxetine engaging in suicidal or self-harming behaviors compared to only one person in the group of patients who took the placebo.”
- Jureidini suggested that the drugs’ side effects can make it easy to work out who is taking them. Potentially this may cast doubt, not just on this individual study, but on all clinical trials of SSRIs, one of the most widely prescribed classes of drugs in the world.
- Publicity from Study 329 contributed to paroxetine being prescribed to “hundreds of thousands” of adolescents, Jureidini said. “We’re only talking about one study, but if this accurately reflects the effects we would expect that many children engaged in suicidal behaviour as a result.”
- Jureidini told IFLScience: “The safety of paroxetine for adults is unclear. The safety analysis may be biased. But we know that the younger you are and the less severe the depression the more likely it is that the harms of SSRIs will outweigh the benefits.”