ADHD drugs may increase risk of suicidal thoughts and behaviours in some people; benefits still outweigh risks

Starting date:
March 30, 2015
Posting date:
March 30, 2015
Type of communication:
Information Update
Subcategory:
Drugs
Source of recall:
Health Canada
Issue:
Important Safety Information
Audience:
General Public, Healthcare Professionals
Identification number:
RA-52759

Issue

Stronger, clearer warnings on the risk of suicidal thoughts and behaviours are being incorporated into the prescribing information for drugs used in the management of Attention Deficit Hyperactivity Disorder (ADHD).

The new warnings advise that there have been reports of suicide-related events in patients treated with ADHD drugs. The reports involved thoughts of suicide, suicide attempts, and in a very small number of cases, completed suicide. These events have been reported at various times during treatment, particularly at the start or during dose changes, and also after stopping the drug treatment.

There are different types of ADHD drugs and the evidence varies with respect to the risk of suicidal thoughts and behaviours. This risk is already known for one ADHD drug, Strattera (atomoxetine), and was incorporated into its prescribing information and communicated in 2005.

New information has emerged since to suggest that the risk of suicidal thoughts and behaviours may apply to all other ADHD drugs. There is little evidence to establish that these drugs cause suicidal thoughts and behaviours, but it is possible that they may contribute to the risk.

It is important to note that people with ADHD may already have a slightly increased risk of suicidal thoughts and behaviours. ADHD may also affect people who have other mental health conditions that are associated with an increased risk of suicide, such as depression or bipolar disorder.

The prescribing information for all ADHD drugs is being revised to include standardized warnings that better reflect the available evidence on the risk of suicidal thoughts and behaviours, except the monograph for Strattera which already includes detailed safety information on this risk.

ADHD drugs are available by prescription only and are authorized for use in adults and children over the age of six years. There are several brand name and generic drugs available in Canada:

  • ADDERALL XR (mixed salts amphetamine extended-release)
  • BIPHENTIN (methylphenidate controlled release)
  • CONCERTA (methylphenidate extended release)
  • DEXEDRINE (dextroamphetamine sulfate)
  • INTUNIV XR (guanfacine extended release)
  • RITALIN (methylphenidate)
  • RITALIN SR (methylphenidate extended release)
  • STRATTERA (atomoxetine)
  • VYVANSE (lisdexamfetamine dimesylate)

It is Health Canada's view that the benefits of these drugs in the effective management of ADHD continue to outweigh their risks. The possible occurrence of psychiatric side effects with ADHD drugs is included in the prescribing information (product monographs) in a warning section that emphasizes the importance of monitoring moods, behaviours, thoughts and feelings in adults and children taking these medications, and the importance of taking psychiatric disorders into account when prescribing these drugs.

For more information, Health Canada has posted Summary Safety Reviews on the risk of suicidal thoughts and behaviours and ADHD drugs containing amphetamines and methylphenidate.

What you should do

  • Patients taking ADHD medications, as well as their parents, families and friends, should monitor for suicidal thoughts and behaviours.
  • Report any distressing thoughts or feelings immediately to your doctor. This applies even after ADHD therapy has been stopped.
  • Consult your doctor if you are considering stopping your ADHD medication or if you have stopped it, as stopping the medication could worsen your ADHD symptoms.
  • Before starting an ADHD medication, tell the doctor or pharmacist if you or your child have experienced or have a family history of mental health problems, including psychosis, mania, bipolar illness, depression or suicide.
  • Talk to your pharmacist or doctor if you have any questions or concerns about your or your child's ADHD therapy.

What industry professionals should do

Additional information for health professionals:

Healthcare professionals should monitor the mental health of patients taking ADHD medications. If concerns arise, appropriate measures to deal with the underlying mental health condition should be taken, and a possible change in the ADHD treatment should be considered.

Report health or safety concerns

To report a side effect to a health product to Health Canada:

  • Call toll-free at 1-866-234-2345
  • Visit MedEffect Canada's web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax.

Media enquiries

Health Canada
613-957-2983

Public enquiries

613-957-2991
1-866-225-0709

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