NEWS AND FACTS ABOUT MEDICINES YOU TAKE

“The effects of amphetamines and methamphetamine are similar to cocaine, but their onset is slower and their duration is longer.”

ABOVE:Drug Enforcement Administration (DEA), US Department of Justice (DOJ). “Drug Fact Sheet: Amphetamines,” undated, retrieved 1/5/2013: www.justice .gov/dea/ druginfo/ drug_data_sheets/ Amphetamines.pdf
Adderall
Adderall XR is a powerful blend of four amphetamines that includes Dexedrine and Benzedrine.

Adderall XR Side Effects and Warnings

Schedule II Substance

  • Brand Names: ADDERALL and ADDERALL XR
  • Generic Name: amphetamine mixed salts
  • Category: RESPIRATORY AND CEREBRAL STIMULANTS

Required “Black Box” Warning Label

Adderall 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 federal 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 amphetamine drugs, including Adderall, which means that medical studies indicate Adderall carries a significant risk of serious, or even life-threatening, adverse effects.

WARNING

AMPHETAMINES HAVE A HIGH POTENTIAL FOR ABUSE.

ADMINISTRATION OF AMPHETAMINES FOR PROLONGED PERIODS OF TIME MAY LEAD TO DRUG DEPENDENCE AND MUST BE AVOIDED. PARTICULAR ATTENTION SHOULD BE PAID TO THE POSSIBILITY OF SUBJECTS OBTAINING AMPHETAMINES FOR NONTHERAPEUTIC USE OR DISTRIBUTION TO OTHERS, AND THE DRUGS SHOULD BE PRESCRIBED OR DISPENSED SPARINGLY.

MISUSE OF AMPHETAMINE MAY CAUSE SUDDEN DEATH AND SERIOUS CARDIOVASCULAR ADVERSE EVENTS.

ABOVE: FDA black box warning label means that medical studies indicate the drug carries a significant risk of serious or even life-threatening adverse effects. The bold warning label appears on the manufacturer's wholesale packaging and is the strongest alert the FDA can require. (Emphasis added.)

Using amphetamines once is sufficient to induce some of these symptoms:

Short-Term Effects:

  • Enhanced mood and body movement
  • Increased wakefulness, physical activity
  • Increased respiration
  • Euphoria
  • Insomnia
  • Increased heart rate
  • Increased blood pressure
  • Reduced appetite
  • Cardiovascular collapse, death
  • Dilated pupils

Long-Term Effects:

  • Damage to brain cells containing serotonin
  • Over time, reduced level of dopamine resulting in Parkinson's-like symptoms
  • Weight loss
  • Confusion
  • Tremors
  • Convulsion
  • Paranoia
  • Hallucinations
  • Damage to nerve cells, causing strokes
  • Cardiovascular collapse, death

Effects from Withdrawal:

  • Irritability
  • Anxiety
  • Paranoia
  • Aggressiveness
  • Fatigue and long periods of sleep
  • Depression

Behaviors resulting from amphetamine intoxication such as withdrawal from others, experiencing hallucinations, paranoia, delirium perhaps occurring with violence and stereotyped behaviors such as repeatedly assembling and dissembling electronic equipment may resemble symptoms of schizophrenia. But a skilled clinician should be able to make the proper diagnosis.

ABOVE: Psychology Today’s Diagnosis Dictionary: Amphetamines; last reviewed by Fiery Cushman on Jan. 10, 2005; captured Jan. 8, 2008.

Description

Adderall and Adderall XR are powerful blends of four amphetamines that include Dexedrine and Benzedrine.

Each ADDERALL XR Tablet Contains 5 mg 7.5 mg 10 mg 15 mg 20 mg 30 mg
Amphetamine Aspartate 1.25 mg 1.875 mg 2.5 mg 3.75 mg 5.0 mg 7.5 mg
Dextroamphetamine Sulfate USP 1.25 mg 1.875 mg 2.5 mg 3.75 mg 5.0 mg 7.5 mg
Amphetamine Sulfate USP 1.25 mg 1.875 mg 2.5 mg 3.75 mg 5.0 mg 7.5 mg
Dextroamphetamine Saccharate 1.25 mg 1.875 mg 2.5 mg 3.75 mg 5.0 mg 7.5 mg
TOTAL AMPHETAMINES 3.1 mg 4.7 mg 6.3 mg 9.4 mg 12.6 mg 18.8 mg
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Used For

  • Attention deficit disorder
  • Narcolepsy
  • Depression
  • Obesity

How Amphetamines Work

When we are stressed or under threat, the central nervous system prepares us for physical action by creating particular physiological changes. Amphetamines prompt the brain to initiate this ‘fight or flight’ response. These changes include:

  • The release of adrenalin and other stress hormones
  • Increased heart rate and blood pressure
  • Redirected blood flow into the muscles and away from the gut

In small doses amphetamines can banish tiredness and make the user feel alert and refreshed. However, the burst of energy comes at a price. A “speed crash” always follows the high and may leave the person feeling nauseous, irritable, depressed and extremely exhausted.

Do Not Use If

You have not tried other psychotherapy, 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, or have Tourette syndrome. Do not combine with monoamine oxidase inhibitors.

Common Side Effects

  • Dry Mouth
  • Loss of appetite
  • Headache
  • Difficulty falling asleep (insomnia)
  • Nervousness including agitation, anxiety and irritability
  • Addiction

Less Common Side Effects

  • High blood pressure
  • Rapid pulse rate
  • 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 Warning: Links Between ADHD Drugs and Priapism and Sexual Dysfunction

In a recent drug-safety announcement, the FDA announced that drugs containing methylphenidate 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 safety warning also raised concerns about links between priapism and amphetamine drugs, which include Adderall.

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

Amphetamines have been extensively abused. Extreme psychological dependence and severe social disability have resulted. Abuse of amphetamines 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

Amphetamine-Induced Anxiety Disorder

The onset of amphetamine-induced anxiety disorder can occur during amphetamine use or withdrawal, according to best-selling psychiatry text, Kaplan and Sadock's Synopsis of Psychiatry citing the American Psychiatric Association's Diagnostic and Statistical Manual of Mental Disorders.

“Amphetamine, as with cocaine, can induce symptoms similar to those seen in obsessive disorder, panic disorder, and phobic disorders,” states Synopsis of Psychiatry.

Adderall-Induced Psychosis

Induction of schizophrenic-like states in children on prescribed doses of stimulant medications, including Adderall, have been observed, though not as well documented as with amphetamine abusers, according to The Journal of the American Board of Family Medicine in an article entitled, “Adderall-Induced Psychosis in an Adolescent.”

Amphetamine-Induced Sexual Dysfunction

Referring again to American Psychiatric Association’s Manual of Mental Disorders, Synopsis of Psychiatry states: “High doses and long-term use of amphetamines are associated with erectile disorder and other sexual dysfunctions.”

Adderall and Adderall XR are Schedule II Substances, which means that Adderall and Adderall XR have a “high potential for abuse” that “may lead to severe psychological or physical dependence,” and the federal government sets limits on the amount of these amphetamine drugs that may be manufactured each year.

ABOVE: 21 USC Sec. 812 01/22/02. Drug Enforcement Administration (DEA), US Department of Justice (DOJ).

“Amphetamine, as with cocaine, can induce symptoms similar to those seen in obsessive disorder, panic disorder, and phobic disorders.”

ABOVE: Kaplan and Sadock's Synopsis of Psychiatry (2007) citing American Psychiatric Association's Diagnostic and Statistical Manual of Mental Disorders.

Dependence, Tolerance and Withdrawal

It is possible to build up a tolerance to amphetamines, 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 amphetamines 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.

Abrupt cessation of Adderall and Adderall XR can cause extreme fatigue and severe, even suicidal, depression in adult patients.

ABOVE: The Essential Guide to Psychiatric Drugs—Rev. and updated (2007).

If It Does Work

“In the treatment of ADHD for children and young adults, Adderall XR is now prescribed frequently, often as a first-line drug. This is, in my opinion, a very serious mistake,” states Jack M. Gorman, M.D., professor of psychiatry at Columbia University and deputy director of the New York State Psychiatric Institute. “Adderall is now abused throughout college campuses, where it is bought, sold, stolen, borrowed, snorted and injected. It is a very powerful drug that undoubtedly works for ADHD, but there are alternatives with less abuse potential that should be tried first.”

“High doses and long-term use of amphetamines are associated with erectile disorder and other sexual dysfunctions.”

ABOVE: Kaplan and Sadock's Synopsis of Psychiatry (2007) citing American Psychiatric Association's Diagnostic and Statistical Manual of Mental Disorders.
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Emergency Paul Hart
Study finds more than triple the risk of developing a tear in the aorta, the huge artery carrying blood out of the heart. An emergency with high potential for fatality.

Young Abusers Risk Fatal Heart Vessel Condition

In a study published in the American Heart Journal, researchers scanned the medical records of nearly 31 million patients nationwide, ages 18 to 49, and found amphetamine abusers faced 3.3 times the risk of developing a torn aorta.

An aortic tear (a tear in the largest artery in the body, also called aortic dissection) is a medical emergency and can quickly lead to death, even with optimal treatment. Complications include rupture, heart attack, permanent kidney failure, stroke and death, according to the National Library of Medicine at the National Institutes of Health. If torn completely open, there is massive and rapid blood loss and an 80 percent mortality rate. Half of patients die before they even reach the hospital.

The torn heart vessel brings on “the most horrible chest pain imaginable,” states a cardiologist at San Francisco General Hospital and the University of California, San Francisco, David Waters, in Science News, reporting on the Journal's study. Patients say, ‘I think I'm going to die,’ and they’re right, he said.

Matt Jeacock
14 of the 20 dead were children. None were associated with misuse or abuse. Initially Canada pulled the psycho-stimulant off the market, but then withdrew its ban.

20 Sudden Deaths Linked to Adderall XR

Adderall XR, a widely used drug for attention deficit hyperactivity disorder, was pulled off the market in Canada after regulators linked the drug to 20 sudden deaths and 12 strokes. Fourteen of the deaths and two of the 12 strokes were in children.

The adverse reactions were not associated with overdose, misuse or abuse of Adderall XR, Canadian regulators said.

The U.S. Food and Drug Administration issued a public health advisory to alert providers to the withdrawal. But the agency also said it had evaluated the same reports as Canadian regulators and did not think the data warranted pulling the drug from the U.S. market.

ADDERALL is a Dextroamphetamine /Amphetamine composite that was originally sold for weight loss. As a medication for ADHD, Adderall was approved for treatment of ADHD in 1996.

“All amphetamines (amphetamine, dextroamphetamine and methamphetamine) have essentially the same chemical properties and their actions are so alike that even experienced users may not feel a difference between them.”

ABOVE: Drug Enforcement Administration (DEA), US Department of Justice (US DOJ). “Amphetamines,” Drugs of Abuse Publication. National Drug Intelligence Center, 2005 ed.
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What do Amphetamines include?
BRAND GENERIC
Adderall amphetamine plus dextroamphetamine
[instant release]
Adderall XR amphetamine plus dextroamphetamine
[extended release]
Benzedrine amphetamine
[instant release]
Biphetamine amphetamine plus dextroamphetamine
Desoxyn methamphetamine
[instant release]
Dexedrine dextroamphetamine
[instant release]
Dexedrine SR dextroamphetamine
[extended release]
Dexedrine Spansule dextroamphetamine
[extended release]
Dextrostat dextroamphetamine
[instant release]
ProCentra dextroamphetamine
[immediate release, bubblegum flavor]
Vyvanse dextroamphetamine
with lysine (lisdexamfetamine)
[extended release]
  • ALTERNATE NAMES:
  • amphetamine = amfetamine = dl-amphetamine
  • dextroamphetamine = dexamfetamine
    = dexamphetamine = d-amphetamine
  • methamphetamine = d-methamphetamine

All amphetamines have essentially the same chemical properties and actions

according the Drug Enforcement Agency (DEA). Amphetamine, dextroamphetamine and methamphetamine are so alike, according to a DEA report, even experienced users may not feel a difference between them.

ABOVE: Drug Enforcement Administration (DEA), US Department of Justice (DOJ). “Amphetamines,” Drugs of Abuse Publication. National Drug Intelligence Center, 2005 ed. usdoj.gov/dea/ pubs/abuse.

What is the most important information I should know about ADDERALL XR?

The following have been reported with use of ADDERALL XR 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 ADDERALL XR.

Your doctor should check you or your child's blood pressure and heart rate regularly during treatment with ADDERALL XR.

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 ADDERALL XR.

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 ADDERALL XR, especially seeing or hearing things that are not real, believing things that are not real, or are suspicious.

ABOVE: Adderall XR Medication Guide, Rev. 03/2009.

“Ritalin and amphetamine (ADDERALL) 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.

High-Fructose Corn Syrup May Hurt Cognition and Memory

Los Angeles, CA—A recent study from the University of California Los Angeles (UCLA) brings new evidence about how high-fructose corn syrup (HFCS) may effect the brain. Researchers measured HFCS influence on insulin signaling, synaptic plasticity in the brain, and behavior. They concluded that HFCS consumption impaired cognitive ability and provided evidence of how HFCS may have more of an effect than previously known on cognition and memory.

ABOVE: Barnes JN, Joyner MJ. “Sugar highs and lows: the impact of diet on cognitive function.” J Physiol 590.12, 2831 (2012). Agrawal R, Gomez-Pinilla F. “Metabolic syndrome in the brain: Deficiency in omega-3-fatty acid exacerbates dysfunctions in insulin receptor signaling and cognition.” J Physiol 590, 2485-2499 (2012).
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