What is Concerta?
Concerta is a brand-name prescription medication indicated to treat attention deficit hyperactivity disorder, or ADHD, in children ages six and older, adolescents and adults younger than 65. It may also be used to treat the sleep disorder narcolepsy in adults.
Concerta is an extended release version of methylphenidate (generic Ritalin). The drug’s time-release formula means patients only need to take one pill per day, as opposed to three pills, three times a day as with other ADHD medications.
How does Concerta work?
Concerta’s main ingredient, methylphenidate, belongs to a class of drugs called stimulants. It can help increase a person’s ability to pay attention, stay focused and control behavior problems.
Stimulants like Concerta work by blocking the reuptake of the neurotransmitters dopamine and norepinephrine in the brain. They do this by acting on the brain’s dopamine and norepinephrine transporters, which are responsible for picking up their respective neurotransmitters from the synapse – the space between two nerve cells — and carrying them back into the cells. Blocking the reuptake and transport leaves more dopamine and norepinephrine in the synapse which leads to increased communication between cells. Scientists believe it is this increase in communication and neurotransmitter activity that helps patients with ADHD.
The half life of methylphenidate is about 3.5 hours on average, but Concerta’s extended release formula means it can work in the body for up to 8 to 12 hours. Concerta usually takes about one hour to kick in and gradually increases in concentration for the next 5 to 9 hours before concentrations begin to decrease.
What is ADHD?
Attention deficit hyperactivity disorder, or ADHD, is a behavioral disorder and one of the most common childhood disorders in the US. In 2011, approximately 11% of 4 to 17 year olds in the US had been diagnosed with ADHD.
ADHD, formerly known as attention deficit disorder, or ADD, is marked by three characteristics: inattentiveness, hyperactivity and impulsivity. ADHD begins in childhood, though sometimes adults are diagnosed later in life with the condition.
The symptoms of ADHD, inattention, hyperactivity and impulsiveness, are often severe enough to interfere with a child’s school work, relationships and self-esteem. Adults with ADHD whose symptoms are not managed may have trouble holding down a job or maintaining meaningful relationships.
In order to be diagnosed with ADHD, a child must meet certain criteria, and symptoms must be present for at least six months and be inappropriate for the child’s developmental level.
According to Healthline.com, symptoms of inattention include:
- Easily distracted
- Forgetful, even in daily activities
- Fails to give close attention to details in school work or activities
- Has trouble keeping attention on tasks or activities
- Does not follow instructions, fails to finish schoolwork or chores, and loses focus or is easily side-tracked
- Has trouble with organization
- Dislikes and avoids tasks that require long periods of mental effort
- Loses vital things needed for tasks and activities, like books, keys, wallet or phone
Symptoms of hyperactivity and impulsivity include:
- Appears to always be on the go
- Excessively talks
- Has severe difficulty waiting their turn
- Squirms in their seat, taps their hands or feet or fidgets
- Runs around or climbs in inappropriate situations
- Is unable to quietly play or take part in leisure activities
- Blurts out an answer before a question has been finished
- Intrudes on and interrupts others constantly
What are the possible side effects of Concerta?
Concerta carries the risk of certain side effects, some of which can be serious. The following are the most common side effects and possible serious side effects associated with Concerta as stated on the drug’s package insert.
Common Side Effects
- Decreased appetite
- Dry mouth
- Trouble sleeping
- Dizziness
- Stomach ache
- Increased sweating
- Headache
- Nausea
- Anxiety
- Weight loss
- Irritability
Serious side effects
- Slowing of growth (height and weight) in children
- Seizures, usually in patients with history of seizures
- Eyesight changes or blurred vision
- Blockage of the esophagus, stomach, small or large intestine in patients who already have a narrowing of these organs
- Circulation problems in fingers and toes
- Priapism, or prolonged and painful erections
- Heart-related problems
- Sudden death in patients with heart problems or heart defects
- Stroke and heart attack in adults
- Increased blood pressure and heart rate
- Mental or psychiatric problems
- New or worse behavior and thought problems
- New or worse bipolar illness
- New or worse aggressive behavior or hostility
- New manic or psychotic symptoms in children and teenagers, like hearing voices, believing things that are not true, or being suspicious
Does Concerta cause psychiatric problems or suicidal thoughts in children and teens?
The FDA issued a news release in 2007 about Concerta and its risk for certain psychiatric problems. The agency said children and teens taking the stimulant are at an increased risk for adverse psychiatric symptoms, including hallucinations, mania and paranoia, even if they had no previous psychiatric problems.
Manufacturers of all ADHD medications, including the makers of Concerta, were required to notify patients and doctors about the increased risk and to include a patient guide with all prescriptions.
On top of the FDA’s warning, numerous studies have found increased risks of suicide in children and teens taking Concerta and other methylphenidate medications.
A 2009 study published in the journal Drug Safety found more cases of suicide among pre-teens and teens taking Concerta or other ADHD drugs. Researchers analyzed more than 18,000 patients aged 2 to 21 years on the UK General Practice Research Database and found more cases of suicide among kids and teens taking ADHD medications, including Concerta, compared to those not taking ADHD medications.
Among 11 to 14 year olds, researchers found there were 16,091% more cases of suicide involving kids taking ADHD medications. Among 15 to 21 year olds, there were 84% more cases of suicide involving teens and young adults taking ADHD medications.
A 2014 study published in the journal SpringerPlus analyzed methylphenidate adverse drug reactions reported to the French Pharmicovigilance Database between 1985 and 2011 and found 181 reported cases. Of those 181 cases, 41% involved neuropsychiatric effects similar to those cited by the FDA.
The majority of cases (143 of 181) involved children with an average age of about 10. Researchers also found that 30% of the reported cases of adverse effects were from patients prescribed methylphenidate off-label. This means almost one-third of reported cases involved drugs that were prescribed for conditions not approved by the FDA.
A 2010 study published in the journal European Psychiatry studied the rate of ADHD in adolescents who have attempted suicide. The study looked at 23 teens who attempted suicide and found 65% of them were diagnosed with ADHD.
According to the study authors, “These preliminary results suggest a significant association between ADHD and suicidal behavior in adolescents.”
These results are especially troubling considering ADHD medications may be exacerbating these suicidal tendencies.
Who makes Concerta?
Concerta is manufactured by corporate giant Johnson & Johnson and its subsidiary Janssen Pharmaceuticals. In the second quarter of 2016, Janssen reported an estimated $129 million in US sales and $238 million in total worldwide sales of Concerta.
When was Concerta approved by the FDA?
The Food and Drug Administration approved Concerta on August 1, 2000, but the drug’s main ingredient methylphenidate has been used as a stimulant to treat attention deficit disorders since 1955 when the FDA approved Ritalin.
How do I take Concerta?
Concerta is an oral, extended release tablet available in 18 mg, 27 mg, 36 mg, and 54 mg dosage strengths. Concerta should be taken once daily in the morning and swallowed whole with a full glass of liquid. Do not crush or chew Concerta, as the entire drug may be released at once, increasing the chance of adverse side effects. Concerta can be taken with or without food, though taking it with food may help it absorb faster.
Withdrawal / ‘Concerta Crash’
Concerta can cause withdrawal symptoms in patients who stop taking the drug. For this reason, a patient’s doctor may reduce the dosage gradually over time. Symptoms of withdrawal include depression, suicidal thoughts or other mental or mood changes.
Some patients report feeling withdrawal symptoms as the drug starts leaving their body towards the end of the day. The phenomenon is called “Concerta crash” and generally occurs when a person’s dose it too high. Concerta crash can also cause withdrawal symptoms like the inability to focus, irritability and hyperactive behavior.
Overdose
It is possible to overdose on Concerta. If you or your child takes too much Concerta or overdoses, call Poison Control or seek emergency medical attention right away.
Symptoms of a Concerta overdose include agitation, hallucinations, psychosis, lethargy, seizures, an abnormally rapid heart rate or irregular heartbeats, hypertension, and hyperthermia.
Tolerance
Patients taking Concerta for a long time may start to develop a tolerance to the drug. If the drug stops working well, a patient’s doctor may consider switching to a new ADHD medication.
Who should NOT take Concerta?
Concerta is contraindicated in certain patients, meaning it can cause serious adverse effects and those patients should not take Concerta. Do not take Concerta if you or your child:
- are very anxious, tense or agitated
- have glaucoma
- have tics or Tourette’s syndrome, or a family history of Tourette’s syndrome
- are allergic to Concerta
- have mental health problems including psychosis, mania, bipolar illness or depression
Which drugs could interact with Concerta?
Certain drugs may interact with Concerta and cause adverse reactions. The makers of Concerta warn that the following drugs may cause interactions when used along with Concerta:
- MAOIs – monoamine oxidase inhibitors, or MAOIs, should not be used while taking Concerta or two weeks prior to taking Concerta.
- Vasopressors – because Concerta can raise a person’s blood pressure, it should be used cautiously in those taking vasopressor agents to raise low blood pressure.
- Some anticoagulants, anticonvulsants, and some antidepressants – Concerta may inhibit the body’s ability to process coumarin anticoagulants, anticonvulsants, and tricyclic and SSRI antidepressants. Dosages of these drugs may need to be lowered when taking Concerta.
- Alcohol – Alcohol may increase nervous system side effects of Concerta, including drowsiness, anxiety, depression and seizures. It may also cause too much of the drug to be released at one time.
Is Concerta safe to take during pregnancy?
Concerta is a pregnancy category C, meaning the risk of adverse effects to the developing fetus cannot be ruled out. Studies conducted on rabbits in the lab found the drug did have adverse effects on the fetus at doses 40 and 100 times the maximum human dose. Studies in rats did not find adverse effects, but the makers of Concerta say the drug should only be used during pregnancy if the benefits outweigh the potential risk to the baby.
Concerta was shown to pass through milk in studies with rats. It is not known whether Concerta passes through breast milk from mother to baby, but the drugmakers say Concerta should be used with caution in breastfeeding or nursing mothers.
Are there alternatives to Concerta on the market?
There are numerous drugs currently on the market used to treat ADHD in children and adults, including other drugs in the same class as Concerta.
Stimulants
Concerta belongs to the class of drugs called stimulants. There are three main types of stimulants: methylphenidates, amphetamines, and methamphetamine (methamphetamine is rarely prescribed).
The following are a list of currently available methylphenidate stimulants, similar to Concerta, used to treat ADHD on the market in the US:
- Ritalin, Ritalin SR, Ritalin LA (methylphenidate)
- Daytrana (methylphenidate transdermal system)
- Focalin and Focalin XR (dexmethylphenidate)
- Metadate CD (methylphenidate)
- Methylin (methylphenidate)
- Quillivant XR (methylphenidate)
The following are amphetamines used to treat ADHD:
- Adderall, Adderal XR (amphetamine/dextroamphetamine)
- Dyanavel XR (amphetamine)
- Evekeo (amphetamine)
- Dexedrine (dextroamphetamine)
- Vyvanse (lisdexamfetamine)
Methamphetamine is prescribed under the brand name Desoxyn. It is used less commonly as a treatment for ADHD and obesity and mainly as a recreational drug.
Other ADHD Medication
Some medications used to treat ADHD are not stimulants. The following is a list of FDA-approved, non-stimulant medications used to treat ADHD:
- Strattera (atomoxetine)
- Intuniv (guanfacine)
- Kapvay (clonidine)
Are there generic versions of Concerta available?
There is a generic version of Concerta on the market today, sold under the drug’s generic name, methylphenidate. Generic drugs typically cost less and must demonstrate that they work equally as well as their brand name counterparts.
Johnson & Johnson and its subsidiary Janssen Pharmaceuticals lost exclusivity rights over Concerta several years ago, and struck a deal with Actavis (now the generics division of Allergan, Plc) to sell an “authorized generic” version of Concerta. An authorized generic is one that is produced by a brand company and sold as a generic under a private label. The authorized generic has the same inactive ingredients as Concerta, unlike generic versions which must contain only the same active ingredients.
At the time, two generic versions of Concerta were also on the market. These generics, manufactured by Mallinckrodt Pharmaceuticals and Kudco Ireland Ltd., were found to work differently in some patients than brand name Concerta. In 2014, the FDA warned consumers and physicians that these generics released the drug’s active ingredient methylphenidate more slowly over the course of the day. The FDA determined the two generic versions were not equivalent to Concerta, but they were allowed to remain on the market. The FDA’s ruling made it so pharmacies could not substitute Concerta prescriptions for those generics, leaving only the authorized generic as a possible substitute.
How much does Concerta cost?
The cost of brand name Concerta is about $62 for 10 pills, or $6.20 per pill, without insurance and using an online discount coupon. The price of Concerta depends on the dose and whether or not insurance covers some or all of the cost of the prescription.
There is a generic equivalent of Concerta available, which generally costs about half of the brand name prescription, or roughly $3 per pill using a discount coupon.
Has Concerta been recalled?
Concerta has not been recalled by the FDA for any safety reasons and remains on the market.
Has the FDA issued any warnings about Concerta?
The FDA has issued several warnings concerning Concerta since it was approved in 2000, including warnings about new or worsening mental health issues, heart problems and prolonged erections in boys and men.
Concerta Psychiatric problems
In 2007, the FDA said it would require the makers of all stimulants used to treat ADHD to notify patients of potential psychiatric problems when using their drugs. The manufacturers created patient guides warning of the increased risk of certain mental health problems, even in patients with not prior history. The FDA’s decision was based on the agency’s Pediatric Advisory Committee and Drug Safety Risk Management Advisory Committee.
Concerta Heart problems/sudden death
In the same 2007 press release, the FDA said it would require the makers of all stimulants to warn of the risks of certain heart problems and sudden death in children and adults taking the medications for ADHD.
The FDA subsequently conducted several trials on children and adults to assess the risk of heart attack, stroke and sudden cardiac death. In 2011, it came back with its results and said it did not find an increased risk for certain heart problems in kids or adults taking ADHD medications, however, people with a history of serious heart problems or heart defects generally should not take the drugs.
Priapism
In 2013, the FDA warned consumers of the increased risk of priapism in boys taking Concerta and other similar ADHD medications. Priapism is a potentially life-altering condition that occurs when blood gets trapped in the penis and causes a painful erection that lasts for four hours or more. If left untreated, priapism can cause permanent erectile dysfunction. The FDA warned priapism was especially dangerous in kids, because they may not tell an adult if symptoms occur.
Concerta Black Box Warning
Since its approval in 2000, Concerta has carried a black box warning about the risk of addiction, especially in those with a history of drug or alcohol dependence. Concerta is a schedule II narcotic, meaning it has a high potential for abuse and may lead to severe dependence when used recreationally or for medical purposes.
Are there lawsuits against the makers of Concerta?
Previous lawsuits have been filed against the maker of Concerta due to the drug’s potential to cause heart problems and priapism.
With recent studies linking the ADHD medication to suicidal thoughts and actions in kids and teens and the FDA’s warning about psychiatric problems, new lawsuits may be filed in 2016 by those harmed by Concerta.
How do I file a Concerta lawsuit?
National Injury Help is currently investigating cases for a potential lawsuit against corporate giant Johnson & Johnson and its pharmaceuticals division Janssen, the makers of Concerta.
If you or someone you love took Concerta and suffered from suicidal thoughts, you may be entitled to financial compensation. Call National Injury Help today to speak with a member of our legal team. We can answer your questions and help you determine if your case qualifies for a possible Concerta Lawsuit.
Call National Injury Help today at 1-800-214-1010 or use the form on the right-hand side of your screen.
