Were you fully aware of all the "warnings," "drug dependency risks," "precautions," and "adverse reactions" related to the use of RITALIN?
Many think Ritalin (methylphenidate) is safe, or mild, because so many children use it. However, the government classifies the psychoactive drug with cocaine and morphine because it is highly addictive.
Ritalin should not be used in children under six years, since safety and efficacy in this age group have not been established. Sufficient data on safety and efficacy of long-term use of Ritalin in children are not yet available. Although a causal relationship has not been established, suppression of growth (i.e., weight gain, and/or height) has been reported with the long-term use of stimulants in children. Therefore, patients requiring long-term therapy should be carefully monitored.
Nervousness and insomnia are the most common adverse reactions but are usually controlled by reducing dosage and omitting the drug in the afternoon or evening. Other reactions include hypersensitivity (including skin rash, urticaria [hives], fever, arthralgia [intense burning or stabbing pain caused by irritation of or damage to a nerve], exfoliative dermatitis [peeling skin], erythema multiforme [red blotches or blisters all over the skin] with histopathological [microscopic] findings of necrotizing vasculitis [death of blood vessels], and thrombocytopenic purpura [purplish spots or patches]); anorexia [loss of appetite]; nausea; dizziness; palpitations [irregular, hard or rapid heartbeat]; headache; dyskinesia [muscle spasms]; drowsiness; blood pressure and pulse changes, both up and down; tachycardia [rapid heart rate]; angina [caused by an insufficient supply of blood to the heart muscle]; cardiac arrhythmia [irregularity of the heartbeat]; abdominal pain; weight loss during prolonged therapy. There have been rare reports of Tourette's syndrome. Toxic psychosis has been reported. Although a definite causal relationship has not been established, the following have been reported in patients taking this drug: leukopenia [abnormally low number of white blood cells in the circulating blood] and/or anemia; a few instances of scalp hair loss. In children, loss of appetite, abdominal pain, weight loss during prolonged therapy, insomnia, and tachycardia [rapid heart rate] may occur more frequently; however, any of the other adverse reactions listed above may also occur.
Ritalin should be given cautiously to emotionally unstable patients, such as those with a history of drug dependence or alcoholism, because such patients may increase dosage on their own initiative. Chronically abusive use can lead to marked tolerance and psychic dependence with varying degrees of abnormal behavior. Frank psychotic episodes can occur, especially with parental abuse. Careful supervision is required during drug withdrawal, since severe depression as well as the effects of chronic over activity can be unmasked. Long-term follow-up may be required because of the patient's basic personality disturbances.
Depression may also be treated with drugs called psycho-stimulants. Use of such drugs is reserved for only two situations: (1) patients who have failed to respond to at least two other antidepressants and psychotherapy and who are seriously depressed, and (2) patients with serious and usually terminal medical illnesses such as cancer or AIDS who are depressed and too sick to take other kinds of antidepressants.The reason for these restrictions is that the stimulant drugs are addictive. They include amphetamines (Adderall), sometimes called "speed" or "uppers," methylphenidate (Ritalin), and pemoline (Cylert). The drugs produce a short-term mood elevation even in people who are not depressed. College students take them to stay awake all night and finish term papers.In most people the effects of these stimulant drugs are short-lived and there is often a letdown or "crash" after they wear off. During this "crash" the patient can feel very depressed, sleepy, and sluggish. Furthermore, and very much unlike the other drugs discussed so far in this chapter, stimulant drugs have the potential to induce "tolerance." People who abuse amphetamines and other stimulants--usually in attempts to lose weight or stay awake for prolonged periods--often find that a dose that had worked for a while is suddenly ineffective and they need a higher dose. They then become "tolerant" to the higher dose and have to increase the dose again. Soon, the person is addicted to the drug. Stopping it suddenly leads to a severe withdrawal reaction characterized by bad depression and extreme fatigue. Suicides have been reported in people who suddenly stop taking amphetamines. Given all these problems, why even mention the stimulant drugs? Simply because they are the only drugs that work for some depressed patients. A very small group of usually chronically depressed patients seems to be resistant to every other treatment for depression. These people usually function at a fairly low level relative to their ability and they feel sad and blue all of the time. They complain of fatigue, low interest in life, and inability to concentrate. Many say they have been depressed since childhood. Another small group of patients with very serious medical problems also develops depression. Sometimes the medical problems they have make other antidepressant drugs unsafe, or the medical problems so magnify the side effects of the other antidepressants that the dying patient is made even more uncomfortable. Stimulant drugs may actually be the safest choice in this situation. For these two groups of patients stimulant drugs may be the only answer, even though the patient will probably become addicted. This is not to be taken lightly. The decision to place a patient on a stimulant drug for depression is serious and must be done only after all other efforts are declared either unsafe or ineffective. The patient must understand that he will probably become addicted to the medication and that he should never stop taking it abruptly.
(1976:) Some health professionals fear that these medications may end up being over prescribed. Dr. Carl Kline, an expert in the field of learning disabilities from the University of British Columbia, had this to say:
It is my belief that if these drugs were outlawed, children would not be at all deprived of essential medication, but that doctors would be forced to make more accurate diagnoses and seek better means of handling the hyperactive behavior of a certain small percentage of their little patients.
Until recently, the most important question concerning Ritalin or amphetamine administration has not been asked. Do these drugs make a difference in the long-term outcome? A comprehensive examination of this subject carried out at the Montreal Children's Hospital discovered a startling fact. At the end of five years, hyperactive children who received Ritalin did not differ significantly from children who had not received. Although it appeared that hyperactive kids treated with Ritalin were initially more manageable, the degree of improvement and emotional adjustment was essentially identical at the end of five years to that seen in a group of kids who had received no medication at all.
Parents might want to consider another approach.
Ritalin (methylphenidate) is an amphetamine-like prescription stimulant commonly used to treat Attention Deficit Hyperactivity Disorder (ADHD) in children and adults.
The Food and Drug Administration (FDA) requires the following "black box" warning on all methylphenidate drugs, including Ritalin, which means that medical studies indicate Ritalin carries a significant risk of serious, or even life-threatening, adverse effects.
RITALIN-SR IS A FEDERALLY CONTROLLED SUBSTANCE (CII) BECAUSE IT CAN BE ABUSED OR LEAD TO DEPENDENCE. KEEP RITALIN-SR IN A SAFE PLACE TO PREVENT MISUSE AND ABUSE. SELLING OR GIVING AWAY RITALIN-SR MAY HARM OTHERS, AND IS AGAINST THE LAW.
TELL YOUR DOCTOR IF YOU OR YOUR CHILD HAVE (OR HAVE A FAMILY HISTORY OF) EVER ABUSED OR BEEN DEPENDENT ON ALCOHOL, PRESCRIPTION MEDICINES OR STREET DRUGS.
We don't know exactly why it produces the effects it does. Methylphenidate (Ritalin) was first synthesized in 1944 in an (unsuccessful) attempt to create a stimulant that would not induce addiction or tolerance. Ritalin is very closely related to amphetamine: similar in chemical structure, metabolization and clinical effects. This close connection is the chief reason Ritalin use raises concern among patients and others.
You have high blood pressure or any form of heart disease, are very nervous or have severe insomnia, have a history of addiction to drugs or alcohol. Do not combine with monoamine oxidase inhibitors.
Methylphenidate drugs have been extensively abused. Extreme psychological dependence and severe social disability have resulted. Abuse of methylphenidate drugs may cause a sudden heart attack even in those with no signs of heart disease. Symptoms of overdose that require immediate medical assistance include:
The last dose of the drug every day should be taken several hours before bedtime to prevent insomnia.
Nervousness usually goes away and appetite often returns so that weight loss is rarely dangerous.
If high blood pressure, rapid pulse, paranoia, or tolerance becomes a problem, the drug is usually stopped.
Nothing can be done about the addiction except to remember not to stop taking any version of methylphenidate abruptly.
It is possible to build up a tolerance to methylphenidate, which means the person using the drug needs to take larger doses to achieve the same effect. Over time, the body might come to depend on methylphenidate drugs just to function normally. The person craves the drug and their psychological dependence makes them panic if access is denied, even temporarily.
Withdrawal symptoms can include tiredness, panic attacks, crankiness, extreme hunger, depression and nightmares. Some people experience a pattern of "binge crash" characterized by using continuously for several days without sleep, followed by a period of heavy sleeping.
The drug should be stopped gradually. Withdrawal symptoms are psychological and stopping suddenly can cause extreme fatigue and severe, even suicidal, depression in adult patients.
"Also, in addition to increasing heart rate and blood pressure, causing insomnia and weight loss, and sometimes causing psychotic symptoms, the stimulant medications used for ADHD (methylphenidate and amphetamines) may cause heart disease if taken for a long time. The latter problem led to a debate within the FDA, well covered by newspapers, about whether to issue a special warning to doctors. In the end, the FDA decided not to do this, but the risk remains," reports Jack M. Gorman, M.D., professor of psychiatry at Columbia University and deputy director of the New York State Psychiatric Institute.
HEALTH CANADA (2006): A 16-year-old boy taking extended-release methylphenidate, with no history of sexual dysfunction, experienced priapism (a painful, persistent and abnormal erection unaccompanied by sexual desire or excitation) that would last up to 24 hours whenever he forgot to take his medication. He had been taking 54 mg of the drug daily for about one year for attention deficit hyperactivity disorder (ADHD) and was not taking any other medications. The priapism would resolve after he took his medication. Treatment with extended-release methylphenidate was continued because the product worked well in controlling his ADHD. The patient did not appear to have any sexual dysfunction when he remembered to take his medication. Priapism is not labeled in the Canadian product monograph.
A case of priapism associated with withdrawal from sustained-release methylphenidate has been reported in the literature.
Ritalin LA releases two peak levels of methylphenidate per day:
Ritalin SR delivers methylphenidate into the blood more slowly and continuous over a 6-8 hour period.
Methylphenidate or Ritalin SR |
Ritalin LA |
|---|---|
| 10 mg methylphenidate twice-per-day | 20 mg Ritalin LA once-per-day |
| 20 mg Ritalin SR twice-per-day | 20 mg Ritalin LA once-per-day |
| 15 mg methylphenidate twice-per-day | 30 mg Ritalin LA once-per-day |
| 20 mg methylphenidate twice-per-day | 40 mg Ritalin LA once-per-day |
| 40 mg Ritalin SR twice-per-day | 40 mg Ritalin LA once-per-day |
| 30 mg methylphenidate twice-per-day | 60 mg Ritalin LA once-per-day |
| 60 mg Ritalin SR twice-per-day | 60 mg Ritalin LA once-per-day |
Ritalin may have subtle impacts on cognitive and intellectual processes. Both parents and researchers have noticed that children taking Ritalin sometimes answer questions in ways that seem overly compliant or narrow, suggesting the drug might restrict creative thinking. One study found hyperactive children taking Ritalin offered less varied answers to open-ended questions.
The psycho-stimulants help students bear down on their work, but with odd effects. One college student says he spends “too much time researching a paper rather than actually writing it.” Another student looked back at papers he'd written while on Adderall and found them verbose: “I'd produce two pages on something that could be said in a couple of sentences.”
All these questions need proper scientific answers, but for now much of the discussion is taking place furtively, among an increasing number of Americans who are performing daily experiments on their own brains (or their children's brains).
Not all children with ADD feel better on Ritalin. One teenager said: “It's not the real you. It's a fake person.” Another, after being on Ritalin for seven years, begged his parents not to make him take it, but one of his teachers would not allow him into her classroom unless he had a note signed by the school nurse that he had received Ritalin at school that day. The boys complained of dizziness, stomach upset, inability to sleep, a buzzed feeling, and appetite-loss because of Ritalin.
| BRAND NAME | GENERIC NAME |
|---|---|
| Concerta | methylphenidate hydrochloride (HCI) [extended release] |
| Daytrana | methylphenidate film, transdermal [extended release] |
| Focalin | dextro-methylphenidate (or, dexmethylphenidate) hydrochloride (HCI) [instant release] |
| Focalin XR | dextro-methylphenidate hydrochloride (HCI) or dexmethylphenidate hydrochloride (HCI) [extended release] |
| Metadate CD | methylphenidate hydrochloride (HCI) [extended release: ONE-a-day] |
| Metadate ER | methylphenidate hydrochloride (HCI) [extended release: TWO- or THREE-a-day] |
| Ritalin | methylphenidate hydrochloride (HCI) [instant release] |
| Ritalin LA | methylphenidate hydrochloride (HCI) [extended release: one-a-day, rapid onset with two peak levels] |
| Ritalin SR | methylphenidate hydrochloride (HCI) [extended release: one-a-day, slower onset with more continuous delivery] |
| Attenta† | methylphenidate hydrochloride (HCI) [instant release]; AU |
| Biphentin† | methylphenidate hydrochloride (HCI) [extended release]; CA |
| Equasym† | methylphenidate hydrochloride (HCI) [instant release]; EU |
| Equasym XL† | methylphenidate hydrochloride (HCI) [extended release]; EU |
| Motiron† | methylphenidate hydrochloride (HCI) [instant release]; EU |
| Rubifen† | methylphenidate hydrochloride (HCI) [instant release]; NZ |
The following have been reported with use of RITALIN-SR and other stimulant medicines.
1. Heart-related problems:
Tell your doctor if you or your child have any heart problems, heart defects, high blood pressure, or a family history of these problems. Your doctor should check you or your child carefully for heart problems before starting RITALIN-SR.
Your doctor should check you or your child's blood pressure and heart rate regularly during treatment with RITALIN-SR.
Call your doctor right away if you or your child has any signs of heart problems such as chest pain, shortness of breath, or fainting while taking RITALIN-SR.
2. Mental (Psychiatric) problems:
All Patients
Children and Teenagers
Tell your doctor about any mental problems you or your child have, or about a family history of suicide, bipolar illness, or depression.
Call your doctor right away if you or your child have any new or worsening mental symptoms or problems while taking RITALIN-SR, especially seeing or hearing things that are not real, believing things that are not real, or are suspicious.
