Memorandum on Adverse Event Report for Roaccutane

The following document entitled "Review of Adverse Events reported for Roaccutane for children and adolescents aged under 18 years of age" was located within a Paediatric Working Party document produced by the Committee on Safety of Medicines (CSM) at the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK. - See MHRA website

The MHRA, while awaiting finalization of a European Commission for regulation of medicines on paediatric use took the initiative to formally request completed paediatric study data from companies, where it was known to exist. The MHRA identified nine drugs, including Roaccutane. See MHRA website

The MHRA asked the Marketing Authorisation Holder (MAH) for information on the efficacy and safety of Roaccutane in children, in line with the strategy to improve paediatric access to medicines. The MHRA contacted Roche on 4th May 2004 requesting the submission of all completed paediatric data on Roaccutane as well as a cumulative review of safety. Roche replied on 11th August 2004 and included the application which they had submitted to the FDA on 1st May 2001 for an extension of exclusivity as a consequence of the studies they had undertaken in paediatric patients with the drug (62 volumes of data). In addition, Roche provided to the MHRA a review of all suspected adverse reports for Roaccutane in children (<18 years) for the period 1st Nov 2001 to 31st May 2004 (Period of 2 years and 7 months).

The document entitled "Review of Adverse Events reported for Roaccutane for children and adolescents aged under 18 years of age", copy attached, provides all serious and non serious events from both clinical trials and spontaneous suspected adverse reaction reporting where the patient age was stated to be <18 years. Reports between 01/11/2001 and 31/05/2004 were retrieved. The results are shocking. For the age group 13-17, psychiatric events were the most frequently reported serious adverse event. The following serious events were recorded:

  • 27 cases of completed suicide (4.2%)
  • 36 cases of suicidal attempt (6%)
  • 28 cases of suicidal ideation (4.4%)
  • 119 cases of depression (19%)
  • 5 cases of psychotic disorder
  • 6 cases of obsessive compulsive disorder

    For <13 year olds, there were 25 serious reports which included one report of suicidal ideation and one report of suicide attempt.