What is Concerta?
Concerta (methylphenidate hydrochloride extended-release) is an amphetamine-like stimulant that works by enhancing the effects of neurotransmitters in the brain called norepinephrine and dopamine that control attention and behavior. These areas tend to be underactive in children with attention deficit hyperactivity disorder (ADHD), and it is thought that increasing the activity of norepinephrine and dopamine improves the function of these parts of the brain. Concerta is made by Janssen Pharmaceuticals (a Johnson & Johnson company), and was approved by the U.S. Food & Drug Administration (FDA) on August 1, 2016.
What’s the Problem?
Lawsuits filed against Janssen allege that the company failed to adequately warn about the risk of extreme suicidal thoughts in children and young adults who take Concerta. Plaintiffs argue that had the manufacturer properly warned of these risks, teens would have been prescribed a different drug to treat their ADHD.
Concerta and Suicide
In March 2006, FDA issued a review of psychiatric adverse events associated with ADHD medications. With regards to Concerta, the agency identified at least:
- 121 reports of “overdose, suicidal ideation, suicide attempt, completed suicide and self injurious behavior.”
- 6 fatal outcomes
- One life-threatening event
Most incidences occurred in children and adolescents, with 34% in children age 10 or younger and 38% in patients age 11 to 20. The events resolved after Concerta was discontinued in 26% of cases, and a positive rechallenge was reported in 4 cases.
Suicide Warning Signs
- Talking about suicide and/or death
- Extreme risk taking
- Loss of interest in things one used to care about
- Making comments about being hopeless, helpless or worthless
- Putting affairs in order, tying up loose ends, changing a will
- Sudden, unexpected switch from being sad to being calm or appearing to be happy
- Visiting or calling people to say goodbye
Health Canada Strengthens Concerta Suicide Warning
In March 2015, Health Canada added strengthened warnings about the risk of suicidal thoughts and behaviors to the prescribing information of Concerta and other ADHD medications. The reports involved suicidal thoughts, attempted suicide, and in a small number of cases, completed suicide. These incidences typically occurred when patients started taking ADHD drugs, during dose changes, or after discontinuing treatment.
Concerta Side Effects
- Suicidal thoughts and behaviors
- Completed suicide
- Heart problems
- Drug addiction / abuse
- Mania / psychosis
- Disturbed sleep
- Priapism (painful, long-lasting erections)
Priapism (Long-Lasting Erections)
From 1997-2012, FDA received at least 15 reports of priapism (painful, long-lasting erections) in adults and children who took methylphenidate. Twelve of the cases occurred in children (median age 12.5 years). Two patients required surgical intervention, including one who had a shunt implanted to divert blood-flow away from the penis, and another who had needle aspiration to drain blood from the corpus cavernosum.
ADHD Drugs Widely Over-Prescribed: CDC
Prescriptions for ADHD drugs like Concerta have been skyrocketing in recent years. According to the Centers for Disease Control and Prevention (CDC), the number of children diagnosed with ADHD has increased to 3.5 million from 600,000 over the past 20 years. The number of prescriptions for medications to treat the disorder keeps climbing, and nearly 15% of high school students are now said to have ADHD. Unless we’re facing an epidemic of massive proportions, the vast majority of these prescriptions are unnecessary.
August 2000 – Approved by the FDA
August 1, 2000 – Concerta approved by the FDA
March 2006 – FDA issues review
March 3, 2006 – FDA issues review of psychiatric events with Concerta and other ADHD medications.
December 2013 – FDA Drug Safety Communication issued
December 17, 2013 – FDA Drug Safety Communication issued regarding cases of priapism (long-lasting erection) associated with methylphenidate ADHD drugs.
March 2015 – Health Canada requires stronger warnings
March 30, 2015 – Health Canada requires stronger warnings on the labeling of Concerta and other similar medications regarding suicidal thoughts and ideations.
- “Concerta Drug Approval Package”. U.S. Food & Drug Administration (FDA). August 1, 2000.
- “Psychiatric Adverse Events Associated with Drug Treatment of ADHD: Review of Postmarketing Safety Data”. Department of Health and Human Services: FDA Center for Drug Evaluation and Research. March 3, 2006.
- “FDA Drug Safety Communication: FDA warns of rare risk of long-lasting erections in males taking methylphenidate ADHD medications and has approved label changes”. U.S. Food & Drug Administration (FDA). December 17, 2013.
- “ADHD drugs may increase risk of suicidal thoughts and behaviours in some people; benefits still outweigh risks”. Health Canada. March 30, 2015.
- “Attention-Deficit / Hyperactivity Disorder (ADHD)”. Centers for Disease Control and Prevention (CDC).