NEWS AND FACTS ABOUT MEDICINES YOU TAKE
U.S. DEPT. OF JUSTICE: Ritalin Shares Same Abuse Potential as Amphetamines

“Of particular concern is that ADHD literature prepared for public consumption does not address the potential or actual abuse of methylphenidate. Instead, methylphenidate is routinely portrayed as a benign, mild substance that is not associated with abuse or serious side effects. In reality, however, the scientific literature indicates that methylphenidate [Ritalin] shares the same abuse potential as other Schedule II stimulants. Further, case reports document that methylphenidate abuse can lead to tolerance and severe psychological dependence.”

ABOVE: Drug Enforcement Administration, US Department of Justice. “Methylphenidate, A Background Paper,” NCJRS (National Criminal Justice Reference System) Abstract, NCJ 166349 (1995).
Ritalin
According to most estimates, more than 75 percent of Ritalin prescriptions are for children. Boys are about four times as likely to take Ritalin as girls.

Ritalin Side Effects and Warnings

Schedule II Substance

  • Brand Names: RITALIN, RITALIN LA, RITALIN SR
  • Generic Name: methylphenidate hci (hydrochloride)
  • Category: CEREBRAL STIMULANTS

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

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.

WARNING

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.

ABOVE: FDA black box warning label appears on the manufacturer's wholesale packaging and is the strongest alert the FDA can require.
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's highly addictive.

Used For

  • Attention deficit disorder
  • Narcolepsy

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

  • Addiction
  • Nervousness including agitation, anxiety and irritability
  • Trouble sleeping (insomnia)
  • Decreased appetite
  • Headache
  • Stomach ache
  • Nausea
  • Dizziness
  • Heart palpitations

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)
  • Depression
  • Cocaine craving
  • Dermatoses (infected or diseased skin)
  • Urinary tract infection
  • Infection or viral infection
  • Elevated ALT enzyme levels in the blood (signaling liver damage)

FDA: Links Between ADHD Drugs and Priapism and Sexual Dysfunction

In a 2013 drug-safety announcement, the FDA announced that drugs containing methylphenidate (Ritalin, Concerta, Daytrana, Focalin, Metadate, Methylin, Quillivant) must including warnings about the risk of priapism. It's a serious problem. Priapism is a persistent, usually painful, erection that lasts for more than four hours and occurs without sexual stimulation. If the condition is not treated immediately, it can lead to scarring and permanent erectile dysfunction.

The FDA included an even stronger warning about atomoxetine (Strattera): “Priapism appears to be more common in patients taking atomoxetine than in patients taking methylphenidate products. Health care professionals should be cautious when considering changing patients from methylphenidate to atomoxetine (Strattera).”

The safety warning also raised concerns about links between priapism and amphetamine drugs, which include Adderall, Dexedrine, ProCentra and Vyvanse.

ABOVE: U.S. FDA Drug Safety Communication, “FDA warns of rare risk of long-lasting erections in males taking methylphenidate ADHD medications and has approved label changes.” (12/17/2013).

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:

  • Restlessness
  • Tremor
  • Aggression
  • Hallucinations
  • Panic states
  • Hyperreflexia (overactive reflexes, which can include twitching or spasms)
  • Personality changes
  • Symptoms of depression
  • Seizures or abnormal EEGs
  • High blood pressure
  • Rapid heart beat
  • Swelling of hands/feet/ankles (for example, numbing of the fingertips)
  • Delusions
  • Sweating
  • Vomiting
  • Dehydration
  • 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

  1. The last dose of the drug every day should be taken several hours before bedtime to prevent insomnia.
  2. Nervousness usually goes away and appetite often returns so that weight loss is rarely dangerous.
  3. If high blood pressure, rapid pulse, paranoia, or tolerance becomes a problem, the drug is usually stopped.
  4. Nothing can be done about the addiction except to remember not to stop taking any type of methylphenidate abruptly.
Abrupt cessation of stimulant drugs such as Ritalin can cause extreme fatigue and severe, even suicidal, depression in adult patients.
ABOVE: The Essential Guide to Psychiatric Drugs—Rev. and updated (2007).

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:

  1. first a rapid onset and
  2. 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 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
ABOVE: National Association of Chain Drug Stores, NACDS Chain Pharmacist Practice Memo (July 2002).
“Physiological effects of oral cocaine and methylphenidate (Ritalin) were similar.”
ABOVE: Rush, C.R., et al. “Behavioral pharmacological similarities between methylphenidate and cocaine in cocaine abusers,” Exp. Clin. Psychopharmacol: Feb;9(1):59-73(2001).

Harmful Reactions to ADHD Stimulant Drugs

Brain and Mind Reactions

Obsessive-compulsive behavior
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)
Convulsions
Headache
Stroke
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

Cardiovascular Reactions

Hypertension
Abnormal heart beat
Cardiac Arrest

Other Reactions

Blurred vision
Hair Loss
Dizziness
Hypersensitivity reaction with rash

Withdrawal and Rebound Reactions

Insomnia
Excessive sleep
Evening crash
Depression
Rebound worsening of ADHD-like symptoms
Over-activity and irritability

Endocrine and Metabolic Reactions

Pituitary dysfunction, including growth hormone and prolactin disruption, Growth suppression
Weight loss
Disturbed sexual function

Gastrointestinal Reactions

Anorexia, Nausea, vomiting, bad taste
Stomach ache, Cramps, Dry Mouth, Constipation, diarrhea, Liver dysfunction

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).
Emergency room visits by children ages 10-14 involving Ritalin intoxication or overdoses have now reached the same level as those for cocaine—indicating escalating abuse of the addictive drug.
ABOVE: Diller, L.H. Running on Ritalin: A Physician Reflects on Children, Society, and Performance in a Pill; Bantam Doubleday Dell Pub. Group, Inc. (1998); citing Feussner, G. “Actual Abuse Issues,” Conference Report: Stimulant Use in the Treatment of ADHD, Drug Enforcement Administration, US Department of Justice, Washington DC, Dec. 1996.
Street names for Ritalin include: rits, rids, west coast, jif, mph, diet coke, kiddie coke, kiddie cocaine, vitamin R, R-ball, poor man's cocaine, skippy, skittles, smarties and the smart drug.
ABOVE: U.S. Department of Justice, National Drug Intelligence Center. “Ritalin Fast Facts,” NDIC Product No. 2003-L0559-026 (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, stated the following:

“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.”

Parents might want to consider another approach.

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.
“Ritalin and amphetamine both produce gross reductions in blood flow to the brain thereby creating the conditions for stroke.”
Decreased blood flow to the brain plays a major role in brain disorders, including Alzheimer's.
ABOVE: Breggin, P.R. The Ritalin Fact Book: what your doctors won't tell you about ADHD and stimulant drugs; Perseus Books Group, 2002. Lombard, J. et al. The Brain Wellness Plan; Kensington Pub. Corp., 1998. Mazza M., et al. Primary cerebral blood flow deficiency and Alzheimer's disease: shadows and lights. J Alzheimers Dis. 2011;23(3):375-89. doi: 10.3233/JAD-2010-090700.

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.

What are the differences between the various methylphenidate drugs?

BRAND GENERIC
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]
Methylin methylphenidate hydrochloride
[instant release]
Methylin ER methylphenidate hydrochloride
[extended release]
Quillivant XR methylphenidate hydrochloride
[extended release; liquid]
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
Vyvanse dextroamphetamine
with lysine (lisdexamfetamine)
[extended release]
†Not sold in U.S.
Warnings from Drug Maker's Guide

What is the most important information I should know about RITALIN-SR?

The following have been reported with use of RITALIN-SR and other stimulant medicines.

1. Heart-related problems:

  • sudden death in patients who have heart problems or heart defects
  • stroke and heart attack in adults
  • increased blood pressure and heart rate

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

  • new or worse behavior and thought problems
  • new or worse bipolar illness
  • new or worse aggressive behavior or hostility

Children and Teenagers

  • new psychotic symptoms (such as hearing voices, believing things that are not true, are suspicious) or new manic symptoms

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.

ABOVE: Ritalin-SR Medication Guide, rev. 4/2007.