Hoffman La Roche
Upon advice from the FDA in early March, Roche sent out Dear Doctor letters to US physicians
advising them of labelling changes. The Warnings section will now begin with the following
paragraph in bold type: Psychiatric disorders: Accutane may cause depression,
psychosis and, rarely, suicidal ideation, suicide attempts and suicide. Discontinuation
of Accutane therapy may be necessary. No mechanism of action has been established
for these events. The adverse events section is also revised.