Label Warnings
Label warnings featuring various behavioural and psychiatric disorders was introduced in France and the warning featured suicide as a possible side effect. When P. Bravard published his study in 1993, the label warning specifically featured depression.
Roche did not inform the FDA or other national Health Agencies of the increased label warning appllied in France featuring suicide as a possible side effect
Most countries applied the increased, explicit label warning for Accutane in February to May 1998 featuring various psychiatric disorders including ‘on rare occasions suicide, suicide attempt and suicide ideation’