There have been 10 studies in three countries (United States, Denmark and Australia) on Concerta. These are as follows:
United States, February 1, 2012: The American Journal of Psychiatry published a study where the researchers evaluated a group of new users of Methylphenidate (Concerta) and nonusers. They found that starting Methylphenidate was associated with a 1.8-fold increase in risk of sudden death or ventricular arrhythmia (abnormal heart rate or heart rhythm). Source: Hedi Schelleman, Ph.D.; Warren B. Bilker, Ph.D., et al.,”Methylphenidate and Risk of Serious Cardiovascular Events in Adults,” American Journal of Psychiatry, Vol. 169, No. 2, February 1, 2012.
United States, December 1, 2010: The authors of a study in PLoS One took the Food and Drug Administration’s Adverse Event Reporting System data, and extracted all “serious adverse event” reports for drugs with 200 or more cases received from 2004 through September 2009. They identified 484 drugs, which accounted for 780,169 serious adverse event reports of all kinds, including 1,937 cases meeting their violence criteria. Of the 484 drugs identified, 31 drugs were disproportionately associated with violence. These drugs, accounting for 79% of all the violence cases, included 11 antidepressants, 6 sedative/hypnotics and 3 drugs for attention deficit hyperactivity disorder (including Concerta). The specific cases of violence included: homicide, physical assaults, cases indicating physical abuse, homicidal ideation, and cases described as violence-relates symptoms. The authors concluded, “These data provide new evidence that acts of violence towards others are a genuine and serious adverse drug event that is associated with a relatively small group of drugs. Source: Thomas J. Moore, Joseph Glenmullen, Curt D. Furbert, “Prescription Drugs Associated with Reports of Violence Towards Others,” Public Library of Science ONE, Vol. 5, Iss. 12, December 2010.
Denmark, June 23, 2010: A study in BioMed Central, showed how the prescribing of psychotropic drugs (including Concerta) in infants is rapidly increasing. In attempts to curb the use of these drugs, regulatory authorities have issued various warnings about risks associated with use of these products in childhood. This team of researchers analyzed data submitted to a national adverse drug reactions (ADR) database to categorize ADRs reported for psych drugs in the Danish pediatric population. They found that almost 20% of psychotropic ADRs were reported for children from birth up to 2 years of age and one half of ADRs were reported in adolescents. The authors concluded that, “The high number of serious ADRs reported for psychotropic medicines in the pediatric population should be a concern for health care professionals and physicians.” Source: Lise Aagaard and Ebba H Hansen, “Adverse drug reactions from psychotropic medicines in the paediatric population: analysis of reports to the Danish Medicines Agency over a decade,” BioMed Central Ltd., Vol. 3, No. 176, June 23, 2010.
Australia, February 20, 2010: The Government of Western Australia Department of Health published a study that examined the long-term social, emotional, school-based, growth, and cardiovascular outcomes associated with the use of stimulant medication in the treatment of ADHD. The children were reviewed once they reached 14-years-old. They compared outcomes of children labeled with ADHD and treated with stimulants (including Concerta) and those not treated with stimulants. They found that kids who received a stimulant medication were at increased odds of being identified as performing below age-level by a classroom teacher by a factor of 10.5 times. There was also blood pressure increase in those chronically using stimulant medications. On average, external behavior and attention problems did not change significantly between the ages of 5 and 14 in children with ADHD, regardless of medication use. The results indicating that there is little long-term benefit of stimulant medication in the core symptoms of ADHD. Source: “Rain ADHD Study: Long-term outcomes associated with stimulant medication in the treatment of ADHD in children.” The Government of Western Australia Department of Health, February 20, 2010.
United States,August 29, 2009: The journal Pediatrics assessed the American Association of Poison Control Center’s National Poison Data System for all cases involving people aged 13 to 19 years from 1998-2005. The authors found that calls related to teenaged victims of prescription ADHD drugs (including Concerta) abuse rose 76%. This sharp increase, out of proportion to other calls, suggests a rising problem with teen ADHD stimulant medication abuse. Source: Jennifer Setlik, MD, et al., “Adolescent Prescription ADHD Medication Abuse Is Rising Along With Prescriptions for These Medications,” Pediatrics, August 24, 2009.
United States, June 15, 2009: The American Journal of Psychiatry published a study that provides support for an association between the use of stimulants (such as Concerta) and sudden unexplained death among children and adolescents. Source: Madelyn S. Gould, Ph.D., M.P.H., et al., “Sudden Death and Use of Stimulant Medications in Youths,” The American Journal of Psychiatry, Vol. AiA, June 15, 2009.
United States, February 1, 2009: Pediatrics published a study that found spontaneous case reports of patients treated for ADHD with amphetamine/dextroamphetamine (Adderall), atomoxetine (Straterra), or Methylphenidate (Ritalin/Concerta/Daytrana) indicated a likely causal association between each of these drugs and treatment-emergent onset of signs and symptoms of psychosis or mania, notably hallucinations, in some patients. The authors concluded, “Patients and physicians should be aware that psychosis or mania arising during drug treatment of attention-deficit/hyperactivity disorder may represent adverse drug reactions.” Source: Andrew D. Mosholder, MD, MPH, et al., “Hallucinations and Other Psychotic Symptoms Associated With the Use of Attention-Deficit/Hyperactivity Disorder Drugs in Children,” Pediatrics, Vol. 123, No. 2, pp. 611-616, February 2009.
United States, December 1, 2007: The journal Pediatrics published a study done on children which found that “Stimulants [including Concerta] were associated with an increase in cardiac emergency department visits.” Source: Almut G. Winterstein, et al., “Cardiac Safety of Central Nervous System [CNS] Stimulants in Children and Adolescents With Attention-Deficit/Hyperactivity Disorder,” Pediatrics, Vol. 120, pp. e1494-e1501, December 2007.
United States, November 1, 2006: A Journal of the Academy of Child and Adolescent Psychiatry study found that Methylphenidate (Concerta) used in children caused significant side effects and appeared to slow children’s growth rates. Side effects included insomnia, weight loss and decreased appetite. One child had a seizure thought to be drug related. About a third of parents reported moderate to severe side effects throughout the study, including emotional outbursts and irritability. Source: Tim Wigal, Ph.D., et al., “Safety and Tolerability of Methylphenidate in Preschool Children With ADHD,” Journal of the Academy of Child and Adolescent Psychiatry, 45:11, November 2006.
United States, September 1, 2005: The Oregon Health & Science University, Evidence-Based Practice Center published a report that reviewed 2,287 studies, virtually every study conducted on “ADHD” drugs (including Concerta), and found that there were no trials showing the effectiveness of these drugs and that there was a lack of evidence that they could change “academic performance, risky behaviors, social achievements, etc.” Source: “Drug Class Review on Pharmacologic Treatments for ADHD,” Final Report, Oregon Health & Science University, Evidence-Based Practice Center, September 2005; M. Alexander Otto, “Are ADHD drugs safe?” The News Tribune, September 26, 2005.
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