Secret safety warnings on medicines: A case study of information access requests.
Marc TorkaBarbara J MintzesAlice BhasaleAlice FabbriLucy PerryJoel LexchinPublished in: Pharmacoepidemiology and drug safety (2019)
Our experience highlights unacceptable secrecy concerning safety warnings previously sent to thousands of Australian clinicians. In the absence of explicit regulatory policy supporting disclosure, companies differed in their response. These letters warn of serious and often life-threatening harm and guide safer care; full ongoing public access is needed, ideally in searchable online databases.