Some estimates say up to 10 percent of all children in the United States have attention deficit hyperactivity disorder (ADHD)1. That’s why so many people have turned to medications like Concerta and Ritalin to help manage the mental disorder.
Unfortunately, ADHD drugs like Concerta carry major risks to patients of all ages, especially children and adolescents. Some of the potential side effects remain less publicized by drugmakers, such as suicidal thoughts, heart problems, seizures, and more.
But, patients who have experienced severe and unexpected side effects from Concerta may have some recourse. Those suffering from ADHD and their families have started exploring potential lawsuits against pharmaceutical company Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, over claims that it failed to warn the public of serious side effects.
What is Concerta?
Concerta is a prescription drug used to treat people with ADHD.
ADHD is one of the most common mental disorders affecting children, according to the American Psychiatric Association2. The disorder is defined by inattention, hyperactivity, and impulsivity.
Common Symptoms of ADHD3
- Carelessness or overlooking details
- Losing things
- Easily distracted
- Not following instructions
- Constant talking
- Always moving
- Trouble following conversations
Concerta treats ADHD by acting as a stimulant of the central nervous system. The central nervous system plays an important role in the body by taking in information, processing that information, and reacting accordingly.
Despite being called a stimulant of the central nervous system, Concerta actually calms the brain by releasing chemicals dopamine and norepinephrine. The two chemicals are responsible for regulating movement, attention, pleasure, and mobility. By increasing the chemical levels, it is believed to help increase attention, memory formation, and alertness.
Concerta was first approved for use by the U.S. Food and Drug Administration (FDA) in 2000. It was originally made by the Alza Corporation before it was bought by Johnson & Johnson.
Concerta vs. Adderall
Concerta and Adderall are two ADHD medications that people usually compare and contrast. They are brand names for two generic medications found in other drugs.
The active ingredient of Concerta is methylphenidate. This is the same active ingredient found in Ritalin. The major difference is that Concerta comes in an extended-release formula of methylphenidate, whereas Ritalin is an immediate-release formula. Concerta increases the amount of dopamine over a long period of time, usually 10 to 12 hours.
Adderall, on the other hand, is a mixture of amphetamines. Adderall and Concerta both treat ADHD by increasing the levels of dopamine and norepinephrine in the brain. However, the effects of Concerta are thought to be milder.
Concerta comes in tablet form and is taken by mouth. Because the drug is an extended-release formula, it is usually taken once a day in the morning.
The recommended starting dose for patients is 18 mg for children and teens and 18 to 36 mg for adults. The tablets come in different-sized tablets: 18 mg, 27 mg, 36 mg, and 54 mg.
Doses may be adjusted to get the best treatment results. For example, a child may start with one 18-mg tablet a day the first week, then two 18-mg tablets the second week, and finally three 18-mg tablets the third week4.
Concerta should not be used in children less than 6 years old.
Common Concerta Side Effects
These are some of the most common side effects associated with Concerta:
- Dry mouth
- Stomach pain
- Sore throat
- Common cold
- Blurred vision
- Muscle tightness
- Weight loss
Serious Concerta Side Effects
Concerta also carries more severe consequences that could result in major injury or even death. Here are just some of the major side effects associated with the ADHD drug.
- Cardiovascular Events
- Stomach issues
- Aggressive behavior
Concerta Linked to Suicidal Thoughts
Since the drug was first approved for use, Concerta has been linked to suicidal thoughts and actions.
As early as 2006, the FDA issued a warning of psychiatric side effects after a routine review found more reports of psychiatric reactions like suicidal thoughts and hallucinations than expected5. A study in 2009 also noted an increased risk of suicide in patients under 21 taking ADHD medications6.
The Indian Journal of Psychiatry published two case reports of suicidal ideation in children taking methylphenidate for ADHD7. In one case, an 8-year-old started saying alarming things in the first week of taking the drug in small amounts. The first day, the child said: “I wish to commit suicide.” On the second day, he said: “don’t cremate me if I die.” After stopping the medication, no other suicidal thoughts were expressed.
In the second case, a 7-year-old reportedly said, “I want to die,” while lying in bed under several quilts within the first two weeks of taking methylphenidate. Again, the suicidal expressions stopped shortly after treatment ceased.
By 2015, the regulatory agency of Canada called Health Canada strengthened its warnings on ADHD medications like Concerta to reflect the risk of suicidal thoughts and behaviors in users8.
Regulators Warns of Concerta Addiction Risks
Because many ADHD drugs increase levels of dopamine in the brain, they are susceptible to abuse by patients. In fact, Concerta is labeled as a Schedule II drug under the United States Controlled Substances Act9. This means Concerta has a high potential for addiction and may lead to severe psychological or physical dependence if abused.
The Drug Enforcement Administration warns that “Youngsters have little difficulty obtaining methylphenidate from classmates or friends who have been prescribed it10.”
This is why Concerta carries a black-box warning11 — the strongest warning on a drug label — that the drug “should be given cautiously to patients with a history of drug dependence or alcoholism.”
FDA Issues Warning of Concerta Priapism Risk
Methylphenidate products have also been associated with instances of prolonged erections known as priapism. The rare but potentially painful condition can occur in males at any age taking methylphenidate products like Concerta.
In 2013, the FDA issued a safety communication warning patients about the condition and label changes12.
From 1997 to 2012, there were 15 cases meeting the definition of priapism reported to the FDA. Some of the patients were hospitalized for treatment, including two who required surgical intervention. Four cases reported the condition after stopping treatment with the drug.
“In conclusion, priapism associated with the use of methylphenidate products appears to be rare,” the FDA said. “However, given the potential for serious outcomes, it is important that patients, caregivers, and health care professionals be aware of the need to seek immediate medical attention for priapism to avoid permanent harm.”
As a result of unexpected side effects like suicidal thoughts and cardiovascular issues, users of Concerta and their families have started exploring the possibility of lawsuits.
Drugmakers like Janssen Pharmaceuticals have a responsibility to protect consumers from taking defective or deceptively harmful medications. When they fail to do so, they could be held liable.
Anyone who has suffered an injury from a serious Concerta side effect should contact a qualified attorney to find out about next steps.