Paroxetine is not licenced for use by adolescents or children in the USA or Europe; however, 'off-label' prescribing is not uncommon if a physician perceives there to be benefit to patients. The drug's safety and efficacy in children have been tested in at least five studies sponsored by GSK, only one of which has been published; its results were mixed. Results from other unpublished trials were either mixed or showed no benefit.
The editorial concludes: 'This contest ought to follow the example set by recent tobacco-company litigation. GSK must create a public archive of all documents relating to paroxetine in under-18s. If GSK has nothing to hide, as it claims, it should open its files before being ordered to do so by a court-and do so right now.'
The Lancet