History of Concerta

Concerta is manufactured by Johnson & Johnson’s Janssen Pharmaceuticals subsidiary, and was approved by the FDA in August 2000, for use in children as young as six and adults 65 or younger. In the years since its approval, Concerta has been plagued by reports of serious side effects in users, including extreme suicidal thoughts and behaviors in children and teens. In 2005, just five years after allowing the ADD medication onto the market, the FDA announced that it would be requiring stronger warnings on the labeling of Concerta and similar medications, highlighting a potential increased risk of psychiatric side effects, including suicidal thoughts, psychotic behavior, hallucinations and aggression.

The problems didn’t end there. In 2006, an expert advisory panel for the FDA recommended that Concerta and other popular ADHD drugs carry a “black box” warning regarding the risk of sudden death, cardiac arrest and other problems associated with the medications. That same year, the FDA released a review of psychiatric adverse event reports submitted to the agency in connection with ADHD drugs, which included such side effects as suicidal thoughts, self-harm behaviors, suicide attempts and completed suicides. Of the 121 reports submitted involving the use of Concerta, 34% involved children aged 10 or younger, and 38% involved patients between the ages of 11 and 20. In 26% of cases, the suicidal thoughts and behaviors stopped when the patients stopped taking Concerta.