Summary Safety Review - Amphetamines - Suicidal Thoughts and Behaviours (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

Amphetamines

Potential Safety Issue

Suicidality

Key Messages

  • Amphetamine products (amphetamine, dextroamphetamine and lisdexamfetamine) 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 amphetamine products.
  • The Canadian prescribing information for all amphetamine products will be updated to inform Canadians that rare cases of suicidality were reported in patients taking amphetamine products. Although there is limited evidence showing that amphetamine 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 amphetamine products used to treat attention-deficit hyperactivity disorder (ADHD). This review was prompted by the reporting of suicidal adverse events associated with amphetamine products to Health Canada.

Use in Canada

  • Amphetamine products are marketed under the brand names of DEXEDRINE (dextroamphetamine sulfate), ADDERALL XR (mixed salts amphetamine extended-release), and VYVANSE (lisdexamfetamine dimesylate).
  • Amphetamine products are used for the treatment of ADHD in adults and children 6 years of age and older.

Safety Review Findings

  • Amphetamine products are commonly used in children in Canada.
  • Cases of suicidality have been reported with the use of amphetamine products 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 amphetamine products may contribute to suicidal thoughts or actions in some patients with ADHD, either alone or in association with other mental conditions.
  • At present, there is little information in the scientific literature to determine the role of amphetamine products in causing suicidality.

Conclusions and actions

  • Cases of suicidality have been reported with the use of amphetamine products for the treatment of ADHD. However, there is limited evidence showing that amphetamines were the cause of suicidality.
  • The Canadian prescribing information for all amphetamine products will be updated to inform Canadians that rare cases of suicidality were reported in patients taking amphetamines, 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 amphetamine products.
  • Health Canada will continue to monitor and evaluate the risk of suicidality associated with the use of amphetamine 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.

Date modified: