Table 4.

Iconic cases of pharmacovigilance engagement at the European Medicines Agency, in chronological order

Iconic case of pharmacovigilance engagement
Risk of lipodystrophy with medicines used for highly active antiretroviral therapy: First-time engagement of patient and healthcare professional representatives in a multistakeholder oversight committee for research requested by EMA for an adverse reaction suspected and notified by patients themselves (1999)
Risk of potential carcinogenicity with contaminated nelfinavir-containing products: First-time engagement of EMA where a patient representative was contacted by EMA immediately after a marketing authorisation holder’s notification of a quality defect and before the risk assessment could be started. [Note: The risk assessment demonstrated that the exposure of patients had been below the toxic threshold] (2007)
Risk of teratogenicity with thalidomide: First-time engagement of EMA where victim and patient representatives were brought together at a dedicated meeting (2007)
Risk of progressive multifocal leukoencephalopathy with natalizumab: First-time invitation of patient representatives in a Scientific Advisory Group meeting at EMA regarding the risk of an authorised medicine (2008)
Risk of venous thromboembolism with combined hormonal contraceptives: First-time dedicated meeting with patient and healthcare professional representatives for EMA’s Pharmacovigilance Risk Assessment Committee established in July 2012 under then new legislation (2013)
Risk of teratogenicity with valproate: First-time public hearing at EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) (2017)

EMA European Medicines Agency