Drugs for Attention Deficit Hyperactivity Disorder or ADHD will come with stronger and clearer warnings on the risks of suicidal thoughts and behaviours, Health Canada says.
The new warnings are based on reports of suicidal thoughts, suicide attempts and in a very small number of cases, completed suicide, the regulator said Monday.
The warning is already in place for one ADHD drug, Strattera (atomoxetine), which had the risk information added to its prescribing information or monograph in 2005.
"New information has emerged since to suggest that the risk of suicidal thoughts and behaviours may apply to all other ADHD drugs," Health Canada said.
"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."
People with ADHD may already have a slightly increased risk of suicidal thoughts and behaviours. The disorder many 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 warning is good for parents to be aware of but there is no reason to panic, said Dr. Brett Belchetz, an emergency room physician in Toronto.
"What they haven't really detailed is how many case reports led to this warning? How severe were the case reports and how different is this from what we were seeing in the past?" Belchetz asked.
He called for research on why we're seeing these case reports and whether they are more common than with untreated ADHD.
ADHD drugs are available by prescription only for adults and children over the age of six years.
The brand and generic drugs available in Canada include:
- 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."
Health Canada recommendations include:
- 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.