Many side effects and complications have been linked to the ADHD drug Concerta. Some are serious and potentially deadly, including sudden cardiac arrest in children and adults with structural heart deformities, psychosis and suicide.
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.
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.
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.
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.
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 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.
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.
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.
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.
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
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.
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.
Please seek the advice of a medical professional before making health care decisions.
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