Concerta (methylphenidate hydrochloride) is a potentially dangerous drug used to treat children and adults with attention deficit-hyperactivity disorder (ADHD). As a stimulant and Schedule II controlled substance (meaning it’s dangerous, according to the Drug Enforcement Administration), as well as its design as an extended-release tablet (meaning it’s active in the body for a prolonged period of time), the medication has been linked to several serious and potentially life-threatening side effects.
Side effects can include cardiac arrest, stroke, heart attack, psychosis and thought disorders, seizures, prolonged erections in males, impaired growth in children, visual impairments, gastrointestinal obstructions and low blood cell and platelet counts.
Concerta users may become dependent on the drug because of its euphoric effects. Withdrawal in such circumstances can lead to severe depression and possibly suicide.
Serious Cardiovascular Events
Concerta has been linked to sudden death at usual doses in children and adolescents with structural cardiac abnormalities or other serious heart problems. In adults, sudden deaths, stroke and heart attacks have been reported after taking stimulant drugs, such as Concerta, at usual doses to treat ADHD.
In adult cases, the cause is unknown. However, adults have a greater likelihood than children of having serious structural cardiac abnormalities, cardiomyopathy (a group of disease affecting the heart muscle), serious heart rhythm abnormalities, coronary artery disease (damaged or diseased major blood vessels that supply the heart with blood, oxygen and nutrients), or other serious heart problems.
Complications are more likely to occur in patients with underlying medical conditions, such as preexisting high blood pressure, heart failure, recent heart attack or abnormal rapid heart rhythms that occur in the lower chambers of the heart.
Patients who develop symptoms such as chest pain along with physical effort, unexplained fainting or other signs suggestive of heart disease while taking Concerta or other stimulants, should receive immediate medical treatment.
Cardiovascular Warning Signs
A cardiovascular event is any incident that may cause damage to the heart muscle. An interruption of blood flow in the heart or through the arteries can lead to injury and/or a heart attack (also known as a myocardial infarction, or coronary or cardiovascular event).
Strokes can also be caused by an interruption of blood flow in the brain, such as a blood clot, or bleeding on the brain. High blood pressure, also referred to as hypertension, is one of the risk factors for heart attack and stroke.
- Chest pain that starts in the chest and may spread to the arms, left shoulder, elbows, jaw or back
- Chest heaviness or tightness
- Difficulty breathing or shortness of breath
- Feeling sick or vomiting
- Feeling lightheaded, dizzy or faint
- Breaking into a cold sweat
- Becoming pale
- Numbness of the face, arm or leg, especially on one side of the body
- Confusion, difficulty speaking or understanding speech
- Difficulty seeing with one or both eyes
- Difficulty walking, loss of balance or coordination
- Severe headache
- Psychiatric Adverse Events
Studies have found that symptoms of behavioral disturbance, thought disorder and psychosis may be worsened in patients with preexisting psychotic disorders, such as bipolar illness, after taking Concerta or other stimulant drugs. Patients with bipolar disorder have a greater likelihood of developing mixed or manic episodes.
It has also been found that new psychotic or manic symptoms can surface after treatment with Concerta in patients without a prior history of psychotic illness or mania when Concerta is given at usual doses. These results were found in approximately four out of 3,482 patients treated with methylphenidate (the active ingredient in Concerta) versus zero patients treated with a placebo (dummy pill) in multiple short-term, placebo-controlled studies.
While aggressive behavior is often observed in patients with ADHD in general, it has also been reported in clinical trials and post-marketing reports as a side effect of some medications, such as Concerta, used in the treatment of the brain condition. Accordingly, patients taking Concerta should be regularly monitored for the appearance of or worsening of aggressive behavior or hostility.
In patients with bipolar disorder, or even in patients who have not previously shown any signs of serious mental illness, unusual mood changes may occur. In severe cases, if left untreated, bipolar disorder can lead to suicide.
Signs and symptoms to watch out for may include patients going from very happy (“up”) and active, to very sad and hopeless (“down”) and inactive, and then back again. The “up” feeling is generally referred to as mania, while the “down” feeling is called depression. Normal moods can occur in between an episode.
- Increased physical and mental activity and energy
- Heightened mood, exaggerated optimism and self-confidence; inflated sense of self-importance
- Excessive irritability, aggressive behavior
- Decreased need for sleep without feeling tired
- Racing speech and thoughts, flight of ideas
- Impulsiveness, reckless behavior, poor judgment, easily distracted
- Delusions and hallucinations
- Prolonged sadness or unexplained crying spells
- Significant changes in appetite and sleep patterns
- Irritability, anger, worry, agitation and anxiety
- Pessimism and indifference
- Loss of energy, persistent fatigue and weakness
- Feelings of guilt, worthlessness
- Inability to concentrate or make decisions
- Inability to take pleasure in former interests, social withdrawal
- Unexplained aches and pains
- Recurring thoughts of death
Some clinical evidence suggests that stimulants may lower the convulsive threshold (meaning the smallest amount of stimulation, electric current or drug is required to bring on a convulsion, similar to a seizure) when a patient has a prior history of seizures, prior EEG (a test that measures and records electrical activity of the brain) abnormalities without seizures, or even in patients without a history of seizures or prior EEG evidence of the same.
Seizures are symptoms of a brain problem and not a disease themselves. They result due to a sudden surge of abnormal electrical activity in the brain. This electrical activity is caused by complex chemical changes that occur in nerve cells.
Brain cells act to stimulate or stop other brain cells from sending messages. There is usually a balance that exists between the cells that excite and those that stop these messages. When a seizure occurs, it is typically the result of too much or too little activity in the brain, causing an imbalance between the exciting and stopping activity, according to the Epilepsy Foundation.
- Specific times of day or night
- Lack of sleep/sleep disturbances
- Fever or other illness
- Flashing bright lights or patterns
- Use of alcohol or drugs
- Menstruation/menstrual cycle in women or other hormonal changes
- Low blood sugar
- Lack of nutrition
- Specific foods, excess caffeine or other products
- Use of certain medications, such as Concerta
Types of Seizures
Seizures are generally classified by how and where they begin in the brain. Other factors include a person’s level of awareness during a seizure and whether movements (convulsions) occur during the seizure. Not all seizures cause convulsions. Some have much milder symptoms.
- Generalized Onset Seizures
- seizure affects both sides of the brain; includes seizure types like tonic-clonic, absence or atonic
- Focal Onset Seizures
- seizure affects one area or group of cells in one side of the brain; one type occurs when the individual is awake and aware called a focal aware seizure and another type results in confusion or affected awareness called a focal impaired awareness seizure
- Unknown Onset Seizures
- the beginning of a seizure is not known; this can also be the case when the seizure is not seen or witnessed by anyone, such as seizures occurring at night in a person’s sleep
Most seizures last from 30 seconds to two minutes and can cause long-term harm. When a seizure lasts longer than five minutes, or if a person suffers from multiple seizures without waking in between them, it is a medical emergency requiring immediate treatment.
Seizures are caused by certain medicines, such as Concerta, high fevers, head injuries and certain diseases. Epilepsy is a condition characterized by recurring seizures due to a diagnosed brain disorder.
- Sustained rhythmical jerking movements
- Muscles becoming weak or limp
- Muscles becoming tense or rigid
- Brief muscle twitching
- Epileptic spasms (the body flexes and extends repeatedly)
- Staring spells
- Repeated automatic movements, such as clapping, rubbing of hands, lip smacking, chewing or running
- Changes in sensation, emotions, thinking or cognition (knowledge and understanding)
- Gastrointestinal sensations
- Racing heart
- Lack of movement
Priapism (Prolonged Erection)
Prolonged and often painful erections have been reported by patients using methylphenidate-containing products, such as Concerta, in both children and adults. This condition, referred to medically as priapism, sometimes requires surgical intervention.
Priapism was not reported with initial drug use but developed after taking the drug for some time, and often following an increase in dosing. It also appeared, in some cases, during a period of drug withdrawal or discontinuation.
The FDA warned that priapism can occur in both children and adult males. The condition is not the result of sexual stimulation. Instead, it happens when blood becomes trapped in the penis, leading to an abnormally long-lasting and sometimes painful erection.
In its review, the FDA also received information of two patients who required surgical intervention, one that required a shunt placement, and one that had to have needle aspiration (a biopsy procedure) of the corpus cavernosum (the sponge-like areas of erectile tissue that contain most of the blood in the penis during an erection).
The agency advised that patients taking Concerta who experience erections that last for abnormally long periods of time, are frequent or are painful should seek immediate medical treatment.
What to Watch Out For
Priapism is a rare condition. However, certain medications, such as Concerta, can increase a patient’s risk of developing priapism. Other causes include sickle cell disease, pelvic tumors, pelvic infections, leukemia, genital trauma (injury), spinal cord trauma or recreational drugs. In a third of the cases, the cause is unknown.
There are two types of priapism including ischemic and non-ischemic. Ischemic priapism involves a little or no blood flow as a part of a nonsexual, persistent and often painful erection. This condition is considered a medical emergency and can result in permanent and significant damage to erectile function if not immediately treated.
Non-ischemic priapism involves unregulated blood flow in the cavernous artery that results in a nonsexual, persistent erection. This type of priapism is usually not painful and is not characterized by a rigid penis. Non-ischemic priapism is typically not an emergency and may resolve itself spontaneously within days or months.
Peripheral Vasculopathy and Raynaud’s Phenomenon
Stimulants like Concerta, used to treat ADHD, are linked to peripheral vasculopathy (a general classification for disorders of the blood vessels in a person’s arms, legs or extremities), including Raynaud’s phenomenon. Effects of these conditions were observed in post-marketing reports at different times and various doses in all age groups throughout the course of treatment with Concerta.
It is important to treat the condition causing Raynaud’s phenomenon, according to the National Institutes of Health (NIH). In patients with secondary Raynaud’s phenomenon, like those being treated with certain medications, such as Concerta, that cause narrowing of arteries, gangrene (death of tissue in part of the body) or skin ulcers may occur if an artery becomes completely blocked
What to Watch Out For
Raynaud’s phenomenon is characterized by usually brief episodes, lasting minutes to hours, of vasospasm, or narrowing of the blood vessels. This constricting of the arteries reduces blood flow to the fingers and toes, causing initial discoloration.
The disorder most commonly affects the fingers, but about 40 percent of individuals with Raynaud’s will also experience its effects in their toes. Rarely, the disorder can also affect the nose, ears, nipples and lips.
Cold temperatures and stress are the most common triggers of what is called a Raynaud’s attack. During an attack, blood flow to affected body parts is restricted. The skin may first turn white before turning blue for a short time. As the blood flow returns, the affected areas may turn red, and throbbing, tingling, burning or a feeling of numbness may result.
Other Potentially Serious Side Effects of Concerta
Precautions and warnings included in drug labeling for Concerta also advise patients prescribed the ADHD medication of the potential risks for long-term suppression of growth, visual impairments, gastrointestinal obstruction and abnormal platelet counts requiring regular hematologic monitoring during prolonged treatment with the stimulant drug.
- Long-Term Suppression of Growth
- In a randomized 14-month clinical study, with subsequent follow-up, involving children aged 7 to 10 years, it was found that among those children consistently treated with methylphenidate (the active ingredient in Concerta), they showed a temporary slowing in growth rate (about 2 cm less growth in height and 2.7 kg less growth in weight). Similar findings were demonstrated in children aged 10 to 13 years as a part of a 36-month study. It was concluded that growth should be monitored during treatment of children using Concerta or other stimulants, and therapy should possibly be interrupted or discontinued in patients not growing or gaining height or weight as expected.
- Visual Impairments
- Reports have linked the use of stimulants, such as Concerta, to difficulties with focusing and blurring of vision. Nearly 2 percent of Concerta users reported having blurred vision after taking the drug in two placebo-controlled, double-blind clinical trials. In those studies, some patients were given Concerta and others were given a dummy pill, but neither the patients nor the researchers had knowledge of who was taking what.
- Potential for Gastrointestinal Obstruction
- Concerta tablets, due to their controlled-release design, are unable to change in shape in a patient’s GI tract and therefore, can cause problems for patients with preexisting severe gastrointestinal narrowing. The FDA has received reports of obstructive symptoms after taking Concerta in patients with known preexisting conditions that cause constriction in the GI tract.
- Hematologic Monitoring
- Double-blind clinical trials as well as post-marketing reports have uncovered adverse reactions that include low platelet counts, low white blood-cell counts, or a combination of low white-blood cell, red-blood cell and platelet counts. These conditions may be termed anemia, leukopenia, thrombocytopenia or pancytopenia. If left untreated, these potentially life-threatening conditions of the blood can cause serious infections and disease, and can result in low oxygen levels in vital organs such as the heart, which can lead to a heart attack.
Please seek the advice of a medical professional before making health care decisions.