While many children and teens occasionally daydream in class, forget to complete their homework, fidget while sitting in front of the television, or act impulsively, these behaviors can be signs of attention deficit hyperactivity disorder (ADHD or ADD). This behavior disorder, which is widely diagnosed in children and teens, might impact school performance and relationships with family or friends. Our knowledgeable and caring Concerta injury lawyers currently are reviewing potential legal claims on behalf of children and adolescents who have experienced serious side effects after taking Concerta that might include psychotic episodes, aggressive behavior, hallucinations, sudden cardiac events, or long-lasting erections which can lead to permanent erectile dysfunction.
Free Confidential Case Evaluations: If your or a loved one have experienced serious physical or psychological side effects that might be linked to taking the ADHD medication Concerta, Stern Law, PLLC invites you to call us for a free case evaluation. Patients who suffer psychiatric disorders, heart attack, or suicide might be entitled to financial compensation. Call 1 (844) 808-7529 for your no obligation consultation.
Understanding the Function of Concerta
Concerta (generic: methylphenidate) is a stimulant that affects chemicals in the brain and nerves related to impulse control and hyperactivity. The drug, which is manufactured by Janssen Pharmaceuticals, a subsidiary of Johnson and Johnson, was approved by the FDA for the treatment of ADHD in August 2000. Methylphenidate, the active ingredient in Concerta, functions as an extended release version of the generic form of Ritalin. Because the drug can remain active in the body for as long as twelve hours, children and adolescents do not need to take a dose during the school day. The medication works by balancing and boosting neurotransmitters in the brain.
FDA Warnings and Regulatory Actions Related to Concerta
The FDA has taken multiple actions to advise consumers of the potential adverse psychiatric effects which include the increased risk of suicide associated with the widely prescribed ADHD drug. The FDA issued a news release in 2008 advising psychiatrists, parents, and patients of the risk of psychiatric problems linked to use of Concerta to treat ADHD. The FDA news release advised of an increased risk of paranoia, hallucinations, mania, and other psychiatric problems associated with child and adolescent use of Concerta even among patients with no prior history of psychiatric disorders. The federal agency required the drug manufacturer to alert physicians and patrons regarding this heightened risk and to include a patient guide when the vehicle is prescribed.
The ADHD drug has carried a Black Box Warning since the drug was approved by the FDA in 2000. This warning advises of a risk of dependence and that the medication should be used with caution by patients with prior drug or alcohol addiction. A Black Box Warning is the most serious warning required by the FDA which is only used when a drug poses a threat of serious injury or death.
Clinical Studies and Scientific Evidence of Psychiatric Side Effects and Increased Suicide Risk
Scientific evidence exists that indicates a link between Concerta and several serious side effects that include an increased risk of suicidal ideation, psychiatric problems, sudden cardiac emergencies, and priapism (erections of an unsafe duration).
A 2009 study published in the Drug Safety Journal reported a 162 times greater risk of suicide among children 14 and under who were taking Concerta compared to children not taking the drug.
The Toronto Star published an investigation in 2012 that examined the link between Concerta and other ADHD drugs and serious psychiatric side effects. The analysis involved the review of approximately 600 adverse incident reports involving children taking ADHD drugs over a ten-year period. The article concluded 76 of the children thought about committing suicide. One in three of these children were under the age of 10. The report included 12 specific cases of suicidal ideation among these children who had taken Concerta. The numbers are particularly concerning because suicide is rare amongst young children.
A study published in the journal Pediatrics analyzed 49 randomized, controlled clinical trials involving these types of products. Eleven psychosis/mania adverse events were reported during 743 person-years of double-blind treatment with no comparable adverse events in 420 person-years of placebo exposure. In a separate study published in the Journal of Academy of Child and Adolescent Psychiatry, the researchers found that Concerta (methylphenidate) use by children resulted in a third of parents indicating their children experienced moderate to severe side effects, which included irritability and emotional outbursts.
Sudden Cardiac Events
A U.S. study published in the American Journal of Psychiatry found a 1.8-fold higher risk of ventricular arrhythmia or sudden death. Another study published in the same journal reported a link between use of stimulants like Concerta and sudden and unexplained death when used by children and adolescents. Pediatrics published research indicating the use of stimulants like Concerta resulted in a higher number of emergency room visits for urgent cardiac events.
Speak with a Proven and Compassionate Concerta Side Effects Attorney
Concerta side effects attorney Ken Stern is accepting lawsuits from patients who have experienced serious adverse events after taking the Concerta including suicidal ideation, psychiatric problems, erectile dysfunction, and sudden cardiac events. Stern Law, PLLC is committed to helping our clients obtain the financial compensation they need quickly. We invite you to contact Stern Law, PLLC today at 1 (844) 808-7529 or submit an online form for assistance.