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Concerta Lawsuit


Concerta is a long-acting stimulant for children with ADHD. Unfortunately, there is evidence that it could increase the risk of suicidal thoughts or behaviors, especially in younger patients.

What is Concerta?

Concerta was one of the first extended-release versions of methylphenidate (generic Ritalin). It is active for 12 hours, which is beneficial when treating children with ADHD because they do not need to take the medication in school. Concerta is designed to replace 3 daily doses of immediate-release methylphenidate.

Concerta and Suicide

Concerta side effects include depressed mood, rapid mood swings, and abnormal thoughts or or thoughts of suicide. When combined with underlying impulsivity from ADHD, these side effects may result in suicide attempts or completed suicide — especially in young patients.

Case Reports of Suicidal Behavior

There have been a number of case reports of young children who experienced suicidal behavior:

  • Case Report #1: An 8 year-old boy with ADHD was prescribed 5-mg of methylphenidate per day. In the first two days of treatment, he said without any context, “I wish to commit suicide” and “don’t cremate me if I die.”
  • Case Report #2: A 7 year-old boy with ADHD was prescribed 10-mg of methylphenidate per day. After less than two weeks of treatment, he laid on a bed under six or seven blankets and said “I want to die.” He also started slapping himself and tied a garden hose around his neck.

FDA Investigates Concerta Suicide Risk

In June 2005, the FDA reviewed the use of Concerta in children and found reports of psychiatric adverse events, including suicidal thoughts, hallucinations, and violent behavior. Other methylphenidate ADHD medications were linked to similar reports.

FDA safety investigator Kathleen Phelan said, “Stimulant drugs may exacerbate symptoms and reveal them for the first time in children with previously unrecognized psychiatric illnesses.”

Canada Strengthens Suicide Warnings on Concerta

In March 2015, Health Canada issued stronger, clearer warnings about the risk of suicidal thoughts and behaviors from Concerta and other ADHD medications. The reports involved suicidal thoughts, suicide attempts, and in a very small number of cases, completed suicide. These events mostly occurred at the start of treatment, during dose changes, or after stopping treatment.

Warning Signs of Suicide

One of the most common warning signs of suicide is a change in behavior or new behaviors, especially after a painful event. Other symptoms may include:

  • Talking: Talking about being a burden, feeling trapped, unbearable pain, having no reason to live, or wanting to kill themselves
  • Behavior: Looking for a way to kill themselves, acting recklessly, withdrawing from activities, isolation, sleeping too much or too little, saying goodbye, giving things away, aggression
  • Mood: Depression, loss of interest, rage, irritability, humiliation, anxiety

Cardiovascular Risks

Evidence linking Concerta and cardiovascular risks is inconclusive. Several years ago, the FDA warned that they received 54 reports of non-fatal cardiovascular events in association with methylphenidate. In addition, there were 25 deaths (19 in children) between 1999 and 2003.

In 2011, the FDA found no increased risk based on a study involving more than 1.2 million children. However, they still warn that Concerta should not be used in patients with serious heart problems, or for whom an increase in blood pressure or heart rate would be problematic. In addition, they recommend that patients on Concerta should be periodically monitored for changes in heart rate or blood pressure.


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