Concerta, a popular ADHD medication that has been prescribed throughout the United States for adolescent ADHD has come under strict scrutiny, according to several published studies, calling into question the alleged increased risk of suicide in adolscents including pre-teens.
As of January 2019, there has not been a recall of Concerta for issues related to children and suicide. Case reports of suicidal thoughts in children taking Concerta have not prompted any changes to the label warning doctors of such risks.
In other parts of the world, the government is addressing this known and serious risk. For example, in 2015 Canada required a warning for Concerta that specifically addresses the drug’s potential to increase the risk of suicide. The Canadian product label warns that patients should be monitored at every adjustment dose of the drug and at least every six months and at every doctor’s visit for development or worsening of psychiatric disorders.
Additionally, the Canadian product label warns about suicidal tendencies and advises that patients with emergent suicidal thoughts or behavior during treatment should be evaluated immediately by a physician.
One study in the Drug Safety Journal found a 162-fold increase in suicide rates for the under-14 age group in patients taking ADHD medications, including methylphenidate (the same active ingredient found in Concerta), when compared to the general population. The study also notes that, “under-reporting was likely to underestimate the incidence of these events.” To read more, click Drug Safety Journal
Another study in Pediatrics analyzed data from 49 randomized, controlled clinical trials in the pediatric development programs for these products. A total of 11 psychosis/mania adverse events occurred during 743 person-years of double-blind treatment with these drugs, and no comparable adverse events occurred in a total of 420 person-years of placebo exposure in the same trials. To read more, click Pediatrics
For a comprehensive review of the studies involving Concerta, click CCHR International