Summary Safety Review - Methylphenidate - Suicidal Thoughts and Behaviour (Suicidality)

Review decision

A Summary Safety Review complements other safety related information to help Canadians make informed decisions about their use of health products. Each summary outlines what was assessed in Health Canada’s review, what was found and what action was taken by Health Canada, if any.


Issued: 2015-03-30

Product

Methylphenidate

Potential Safety Issue

Suicidality

Key Messages

  • Methylphenidate products are used for the treatment of attention-deficit hyperactivity disorder (ADHD) in adults and children 6 years of age and older.
  • A safety review was initiated after Health Canada received reports of suicidality associated with methylphenidate products.
  • The Canadian prescribing information for brand name and generic methylphenidate products will be updated to inform Canadians that rare cases of suicidality were reported in patients taking methylphenidate products. Although there is limited evidence showing that methylphenidate was the cause of suicidality, it is recommended that patients be monitored for signs of suicidality.

Overview

A safety review was initiated to evaluate the available information regarding the potential risk of suicidal thoughts and behaviours, called suicidality, with the use of methylphenidate products used to treat attention-deficit hyperactivity disorder (ADHD). The findings of a recently completed review of amphetamines and the potential risk of suicidality raised the question of whether other stimulant drugs, like methylphenidate products, had a similar risk. This review was prompted by the reporting of suicidal adverse events associated with methylphenidate products to Health Canada.

Use in Canada

  • Methylphenidate is marketed under the brand names of BIPHENTIN, CONCERTA, RITALIN and RITALIN SR. and 16 generic methylphenidate products in Canada, at the time of this review.
  • Methylphenidate products are used for the treatment of ADHD in adults and children 6 years of age and older.

Safety Review Findings

  • Methylphenidate products are commonly used in children in Canada.
  • Cases of suicidality have been reported with the use of methylphenidate for the treatment of ADHD in Canadaa and internationally.
  • ADHD can be associated with other mental health conditions that may increase the risk of suicidal thoughts and behaviours.
  • While most Canadian reports were about suicidal thoughts, a small number of suicide attempts and suicides were also reported. In general, the review of Canadian cases suggests that the use of methylphenidate products may contribute to suicidal thoughts or actions in some patients with ADHD, either alone or in association with other mental health conditions.

Conclusions and actions

  • Cases of suicidality have been reported with the use of methylphenidate products for the treatment of ADHD. However, there is limited evidence showing that methylphenidate products were the cause of suicidality.
  • The Canadian prescribing information for brand name and generic methylphenidate products will be updated to inform Canadians that rare cases of suicidality were reported in patients taking methylphenidate products, recommend that patients be monitored for signs of suicidality, and encourage patients to report any distressing thoughts or feelings to their healthcare professional.
  • Health Canada has issued a communication to inform Canadians about the risk of suicidality associated with the use of methylphenidate products.
  • Health Canada will continue to monitor and evaluate the risk of suicidality associated with the use of methylphenidate products. It will keep Canadians informed and take action, as appropriate, if any new safety information is identified.

Additional information

The analysis that contributed to this safety review included scientific and medical literature, Canadian and international adverse reaction reports and what is known about the use of this drug both in Canada and internationally.

For additional information, contact the Marketed Health Products Directorate.

Footnotes

  1. Canadian reports can be accessed through the Canada Vigilance Adverse Reaction Database.

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