Concerta, a popular ADHD medication being prescribed to adolescents across the country is coming under strict scrutiny as a result of recent studies calling into question the safety of the drug.

A recent 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

A separate 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.

As of January 2019, there has not been a recall of Concerta for issues related to children and suicide. In spite of case reports of suicidal thoughts in children taking Concerta, the drug label has yet to be revised to warn physicians.

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 6 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.

For a comprehensive review of the studies involving Concerta, click CCHR International