Ritalin (methylphenidate) is an amphetamine-like prescription stimulant commonly used to treat Attention Deficit Hyperactivity Disorder (ADHD) in children and adults.
Were you fully aware of all the “warnings,” “drug dependency risks,” “precautions,” and “adverse reactions” related to the use of RITALIN?
FDA “Black Box” Warning Label
Ritalin is a “Schedule II Substance” which means it has a “high potential for abuse” and “may lead to severe psychological or physical dependence,” and so the government sets limits on the amount that may be manufactured each year. (21 USC Sec. 812)
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.
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.
Attention deficit disorder
How Ritalin Works
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.
Do Not Use If
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.
Common Side Effects
Nervousness including agitation, anxiety and irritability
Trouble sleeping (insomnia)
Other Serious Side Effects Include
Slowing of growth (height and weight) in children
Seizures, mainly in patients with a history of seizures
Eyesight changes or blurred vision
Less Common Side Effects
High blood pressure
Rapid pulse rate (and other heart problems)
Tolerance (constant need to raise the dose)
Feelings of suspicion and paranoia
Visual hallucinations (seeing things that are not there)
Dermatoses (infected or diseased skin)
Urinary tract infection
Infection or viral infection
Elevated ALT enzyme levels in the blood (signaling liver damage)
Overdose Side Effects
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:
Hyperreflexia (overactive reflexes, which can include twitching or spasms)
Symptoms of depression
Seizures or abnormal EEGs
High blood pressure
Rapid heart beat
Swelling of hands/feet/ankles (for example, numbing of the fingertips)
Unexplained muscle pain
Lower abdominal pain
Rhabdomyolysis and kidney damage
Chronic abuse can manifest itself as psychosis, often indistinguishable from schizophrenia
What to Do About Side Effects
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 type of methylphenidate abruptly.
Dependence, Tolerance and Withdrawal
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.
If It Doesn't Work
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.
If It Does Work
“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. Ritalin “is a very powerful drug that undoubtedly works for ADHD, but there are alternatives with less abuse potential that should be tried first.”
What is the Difference Between Ritalin LA and Ritalin SR?
Ritalin LA releases two peak levels of methylphenidate per day:
first a rapid onset and
another release about four hours later.
Ritalin SR delivers methylphenidate into the blood more slowly and continuous over a 6-8 hour period.
Ritalin LA Dosage Conversion Table
Methylphenidate or Ritalin SR
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
ABOVE: National Association of Chain Drug Stores, NACDS Chain Pharmacist Practice Memo (July 2002): nacdsfoundation .org.
Harmful Reactions to Stimulant Drugs: Ritalin, Dexederine, Adderall, Concerta, Metadate
Brain and Mind Reactions
Zombie-like (robotic) behavior with loss of emotional spontaneity
Drowsiness 'dopey,' reduced alertness
Abnormal movements, tics, Tourette’s
Nervous habits (picking at skin, pulling hair)
Mania, psychosis, hallucinations
Agitation, anxiety, nervousness
Irritability, Hostility, Aggression
Confusion, mental impairments (decreased cognition and learning)
Depression, emotional, sensitivity, easy crying, social withdrawal
Stimulant addiction and abuse
Abnormal heart beat
Hypersensitivity reaction with rash
Withdrawal and Rebound Reactions
Rebound worsening of ADHD-like symptoms
Over-activity and irritability
Endocrine and Metabolic Reactions
Pituitary dysfunction, including growth hormone and prolactin disruption, Growth suppression
ABOVE: Breggin, P.R. Talking back to Ritalin: what doctors aren't telling you about stimulants and ADHD, revised ed. Cambridge, MA: Perseus Books Group, (table 1, p. 32) 2001: cited references include: Breggin, P. “Psychostimulants in the treatment of children diagnosed with ADHD: Risks and mechanism of action.” Intl Journal of Risk and Safety in Medicine, 12, 3-35, 1999. Breggin, P. “Psychostimulants in the treatment of children diagnosed with ADHD: Part I: Acute risks and psychological effecs.” Ethical Human Sciences and Services, 1, 13-33, 1999. Arnold, L.E. and Jensen, P.S. Attention-deficit disorders, in H.I. Kaplan and Sadock, B. (Eds.). Comprehensive Textbook of Psychiatry, VI (table 38-5 p. 2306, table 38-7, p 2307), Baltimore: Williams & Wilkins, 1995. Drug Enforcement Administration (DEA), Methylphenidate (a background paper). Washington DC: Drug and Chemical Evaluation Section, Office of Diversion Control, DEA, U.S. Department of Justice, p. 23, 1995. Dulcan, M. “Treatment of children and adolescents,” in R. Hales, Yudofsky, S. and Talbot, J. (Eds.), The American Psychiatric Press textbook of psychiatry, (Second Edition) (table 35-6, p. 1217), Washington DC: American Psychiatric Press, 1994. Maxman, J.S. and Ward, N.G. Psychotropic drugs fast facts, second edition. New York: W.W. Norton (1995). Food and Drug Administration (1997).
Ritalin Side Effects from The Essential Guide to Psychiatric Drugs
STIMULANT ANTIDEPRESSANT DRUGS
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).
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...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
Stopping the drug 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
for use in depression? 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.
Ritalin: The People's Pharmacy
(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
Do these drugs make a difference in the long-term outcome?
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-SR Medication Guide, rev. 4/2007: fda .gov/downloads/ Drugs/DrugSafety/ ucm089095.pdf
National Institute of Mental Health. Medications. Bethesda, MD: National Institute of Mental Health,
National Institutes of Health, US Department of Health and Human Services; NIH Publication No. 02-3929, 2007 ed.
“Ritalin and amphetamine both produce gross reductions in blood flow to the brain, thereby creating the conditions for stroke.”
ABOVE: Breggin, P.R. The Ritalin Fact Book: what your doctors won't tell you about ADHD and stimulant drugs; Cambridge, MA: Perseus Books Group, 2002.
WARNING BOX FROM DRUG MAKER'S GUIDE
IN THE NEWS
Long-Term Effects of Ritalin: Changes in Brain Development
Ongoing research shows early-life use of Ritalin (methylphenidate) has complex effects that endure later into life. A study published in Biological Psychiatry suggests that exposure of Ritalin in youth may later disrupt development of brain cells in the hippocampus, region of the brain critical to memory, spatial navigation, and behavioral inhibition and resulting in memory problems, disorientation and depression in adulthood.
The same damage can be seen in Alzheimer's disease where the hippocampus is one of the first areas of the brain to suffer damage and so memory problems and disorientation appear among the first symptoms.
ABOVE: Lagace, D.C., et al. Juvenile administration of methylphenidate attenuates adult hippocampal neurogenesis. Biol Psychiatry 60:1121-1130, 2006.
Wang L., et al. Changes in hippocampal volume and shape across time distinguish dementia of the Alzheimer type from healthy aging. NeuroImage vol. 19, 2003. Zhao Z. et al. Hippocampus shape analysis and late-life depression. Plos One 3(3): e1837, 2003.
NY Times: Children's A.D.D. Drugs Don't Work Long-Term
The NY Times, in an op-ed article by L. Alan Sroufe, a professor emeritus of psychology at the University of Minnesota's Institute of Child Development:
“Attention-deficit drugs increase concentration in the short term, which is why they work so well for college students cramming for exams. But when given to children over long periods of time, they neither improve school achievement nor reduce behavior problems. The drugs can also have serious side effects...
“Many parents who take their children off the drugs find that behavior worsens, which most likely confirms their belief that the drugs work. But the behavior worsens because the children's bodies have become adapted [because the drugs are habit-forming] to the drug. Adults may have similar reactions if they suddenly cut back on coffee, or stop smoking.”
ABOVE: L. Alan Sroufe, “Ritalin Gone Wrong: Children's A.D.D. Drugs Don't Work Long-Term,” New York Times, pg SR1, NY ed, 1/28/2012.
Children Diagnosed with ADHD up to Three Times More Likely to Use or Abuse Drugs
Children diagnosed with attention deficit hyperactivity disorder (ADHD) are up to three times more likely
than other kids to use, abuse or become dependent on substances such as nicotine,
cocaine and marijuana in adolescence and as young adults, according to new research published in Clinical Psychology Review.
Lee, S.S., et al. “Prospective Association of Childhood Attention-deficit/hyperactivity Disorder (ADHD) and Substance Use and Abuse/Dependence: A Meta-Analytic Review.” Clinical Psychology Review, 2011 Apr;31(3):328-41. doi: 10.1016/ j.cpr. 2011.01.006. Epub 2011 Jan 20. As reported in: Terbush, S. “Kids with ADHD more likely to use drugs, analysis finds,” USA Today, 4/25/2011.
The use of methylphenidate (RITALIN) and clonidine (KAPVAY, CATAPRES) in combination continues to be controversial. Both drugs can adversely affect an irregular heart rate or rhythm (cardiac arrhythmia) and this effect can be worsened when the drugs are combined. Four deaths of children using both drugs were reported to the FDA. More →
“All major classes of psychiatric drugs—antipsychotics, antidepressants, benzodiazepines, and stimulants for ADHD—can trigger new and more severe psychiatric symptoms in a significant percentage of patients.”
ABOVE: Whitaker, R. “Anatomy of an Epidemic: Psychiatric Drugs and the Astonishing Rise of Mental Illness in America,” Ethical Human Psychology and Psychiatry, Vol. 7 No. 1, 2005.
Surge in ADHD Diagnoses Gets a Red Flag
Doctors sounded a warning in the British Medical Journal over a rise in ADHD diagnoses, saying some children may be needlessly taking powerful drugs intended to correct a poorly understood disorder.
The analysis found Ritalin and other drugs were meant to be used only for “severe” ADHD symptoms, which according to research data only occur among about 14 percent of children with the condition.
Yet “about 87 percent of children diagnosed with ADHD in the US in 2010 subsequently received medication,” it said, warning of “unnecessary and possibly harmful medication treatment.”
ABOVE: “Surge in ADHD diagnoses gets a red flag,” France 24 International News, Nov. 6, 2013: www.france24.com/en/20131106-surge-adhd-diagnoses-gets-red-flag.