Lawsuits are being filed against Concerta after the Attention Deficit Disorder (ADD) medication was linked to an increased risk of suicidal thoughts, gynecomastia and heart attacks. Janssen Pharmaceuticals (a subsidiary of Johnson & Johnson), however, never added this side effect to the medication’s label. Many attorneys brought their cases to court arguing that the absence of a proper warning led many patients to take this medicine without adequate knowledge of its dangers. Since methylphenidate is usually used to treat children and adolescents, doctors may have chosen to prescribe them a different therapy for their condition.

If you or one of your kids suffered from priapism, suicidal thoughts or cardiovascular issues after taking this prescription stimulant, you should seek the help of a competent Concerta lawyer to file a claim. We can offer our legal services for free, call us now for a hour-long, complete consultation about your rights.

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What is Concerta?

Concerta (methylphenidate) is a psychostimulant medication used to treat Attention Deficit Disorder (ADD) and Attention Deficit Hyperactivity Disorder (ADHD). It acts by increasing vigilance and wakefulness, and it’s also indicated for the treatment of narcolepsy. Methylphenidate is a dopaminergic drug that is also contained in the other very similar medicine Ritalin. It increases the levels of dopamine inside the patient’s brain by inhibiting the reuptake of this neurotransmitter. Albeit to a lesser extent, it also increases the levels of norepinephrine. The U.S. Food and Drug Administration (FDA) granted approval to market Concerta on August 2000. Methylphenidate, however, has been already used to treat ADHD for more than 30 years although it may cause withdrawal symptoms, tolerance, and even overdose.

A common misconception about prescription stimulants is they can be used to improve their school grades by enhancing their ability to learn and focus on the homework (cognitive enhancement). However, this is just a myth. In healthy individuals, these drugs have no effect except promoting wakefulness and the National Institute of Drug Abuse even warned about a serious risk of adverse reactions such as seizures, hostility, paranoia and heart attacks. Recent studies also pointed out that students who abuse psychostimulant medications usually show poorer academic results in school and are often victimized by bullies.

Concerta Side Effects

  • Heart attack
  • Suicidal thoughts
  • Priapism
  • Arrhythmia
  • Anxiety
  • Violent behavior
  • Agitation / Mania
  • Psychosis
  • Hallucinations
  • Drug addiction and abuse
  • Depression
  • Disturbed sleep
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Why should I file a litigation against Janssen Pharmaceuticals?

This drug, as well as many other prescription stimulants, have been officially and unofficially overprescribed over the course of the last 30 years. According to data from the Centers for Disease Control and Prevention, adolescents diagnosed with this condition increased to 3.5 million from 600,000 in 20 years. The number of prescriptions keeps growing each year, and nearly 15% of high-school students suffer from ADHD. Unless we’re facing a true epidemic of impressive proportions, most of these diagnoses and prescriptions are just preposterous. A 2014 study published in the journal SpringerPlus analyzed data in the French Pharmacovigilance Database between 1985 and 2011 and found that at leat one-third of adverse reactions reported were caused by off-label methylphenidate prescriptions. These medications are not devoid of dangers, though, and may have many harmful or even lethal side effects such as suicidal behaviors, heart attacks or priapism that were never included on the original label. As Steven Galson, Director of the Center for Drug Evaluation and Research (CDER), explained ADHD medications might be beneficial to some patients but “they may have serious risks as well.” However, patients and doctors were advised about the precautions to take when using those dangerous drugs way too late.

The pharmaceutical companies found a real gold mine in ADHD patients, and this is not the first time that they’re brought to trial on account of their misconduct. In 2014, the U.S. Department of Justice held Shire Pharmaceutical LLC responsible for illegal marketing and promotion of two other psychostimulant medications: Vyvanse and Adderall. To resolve civil allegations about a violation of the False Claims Act, the company opted to pay a settlement of $56.5 million since it overstated the efficacy of Adderall XR promoting it without approval from the FDA. Filing a litigation could be more than just a shortcut to receive a proper cash compensation for all the damage you or your children suffered. Bringing your case in court should be a civil duty to prevent the Big Pharma from keeping up with their unscrupulous behavior. They only care about profit even when your children’s safety is at stake and must be held accountable for their conduct.

Why is this drug dangerous?

In February 2007, the FDA ordered the all the pharmaceutical companies that manufacture prescription stimulants to warn patients affected by ADHD about a new serious risk of heart attacks and extreme suicidal thoughts. A study published in the journal Archives of General Psychiatry in 1995, showed that methylphenidate’s effects on the human body share many similarities to those caused by cocaine. Its cardiovascular effects may then increase the heart rate and led to arrhythmia, tachycardia, and hypertension. A study published in the American Journal of Psychiatry showed the use of Concerta was associated with a 1.8-fold increase in the risk of abnormal heart rhythm and sudden cardiovascular death.

Concerta and suicidal thoughts

ADHD is a childhood neurodevelopmental disorders of characterized by the inability to pay attention and to focus on tasks, inappropriate behavior, impulsiveness and excessive activity. Teens and children affected often show worse school performance than their peers, as well as significant issues with interpersonal relationships and social interactions. ADHD is commonly associated with other disorders (comorbidity) such as anxiety disorders, learning disabilities, obsessive-compulsive disorder (OCD) and self-harming. Suicidal behaviors are often associated with ADHD, so this population of patients is especially vulnerable to this potentially lethal side effect. According to data provided by the FDA as well as the journal Drug Safety, Concerta can predispose to teenage suicide especially in all teenagers with co-existing mood behavior disorders such as depression or antisocial behavior (which affects more than 65 percent of them).

Concerta could cause priapism and psychological damage

In 2013, the FDA issued another warning about an increased risk of priapism in male youths taking Concerta and other methylphenidate-based drugs. Priapism is a medical emergency that causes the male genitalia to get filled with blood, forcing a long-lasting, painful erection even in the absence of psychological or physical stimulation. It may cause life-altering psychological effects especially in kids which cannot tell an adult about their condition, and may also lead to permanent erectile dysfunction.

Health Canada issues a warning against prescription stimulants

In March 2015 Health Canada, the Canadian equivalent of the FDA, required the manufacturers of several prescription stimulants including Concerta, Ritalin, Vyvanse, and Adderall to add an additional warning about their risks. To avoid a potential worsening of their psychiatric disorders, patients under treatment with these medicines must be continuously monitored by a physician, and their conditions re-evaluated every six months.

Written by: Dr. Claudio Butticè, Pharm.D.
Visuals and Design by: Luke Kist