LATEST NEWS AND FACTS ABOUT MEDICINES YOU TAKE
“Amphetamine, as with cocaine, can induce symptoms similar to those seen in obsessive disorder, panic disorder, and phobic disorders.”
Matt Jeacock
20 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.
“High doses and long-term use of amphetamines are associated with erectile disorder and other sexual dysfunctions.”
ADDERALL (a Schedule II controlled substance) is the new name for a Dextroamphetamine/Amphetamine composite medication that has been around for more than 30 years. This formula was also used in a medication known as Obetrol, made in the past by Rexar and developed for weight loss. As a medication for ADHD, Adderall was approved for unrestricted use for treatment of ADHD by the FDA in March 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, according to a 2005 report by the Drug Enforcement Agency (DEA).
Adderall XR is a powerful blend of four amphetamines that includes Dexedrine and Benzedrine.
Adderall XR Side Effects and Warnings
Schedule II Substance
Amphetamine and Dextroamphetamine Composite
- Brand Names: ADDERALL and ADDERALL XR
- Generic Name: AMPHETAMINE MIXED SALTS
- Category: RESPIRATORY AND CEREBRAL STIMULANTS
FDA “Black Box” Warning Label
The Food and Drug Administration (FDA) requires the following "black box" warning on all amphetamines, including Adderall and Adderall XR, which means that medical studies indicate these drugs carry 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.
Description
Adderall and Adderall XR are powerful blends of four amphetamines that includes Dexedrine and Benzedrine. Each contains:
| EACH ADDERALL XR CAPSULE CONTAINS: |
5 mg | 10 mg | 15 mg | 20 mg | 25 mg | 30 mg |
|---|---|---|---|---|---|---|
| Amphetamine Aspartate | 1.25 mg | 2.5 mg | 3.75 mg | 5.0 mg | 6.25 mg | 7.5 mg |
| Dextroamphetamine Sulfate USP | 1.25 mg | 2.5 mg | 3.75 mg | 5.0 mg | 6.25 mg | 7.5 mg |
| Amphetamine Sulfate USP | 1.25 mg | 2.5 mg | 3.75 mg | 5.0 mg | 6.25 mg | 7.5 mg |
| Dextroamphetamine Saccharate | 1.25 mg | 2.5 mg | 3.75 mg | 5.0 mg | 6.25 mg | 7.5 mg |
| TOTAL AMPHETAMINES | 3.1 mg | 6.3 mg | 9.4 mg | 12.5 mg | 15.6 mg | 18.8 mg |
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)
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 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.
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.
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."
- SOURCES:
- Drug Enforcement Administration, US Department of Justice. “Amphetamines,” Drugs of Abuse Publication. National Drug Intelligence Center, 2005 ed.: www.usdoj.gov/dea/pubs/abuse.
- 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.: www.nimh.nih.gov/health/publications/medications/medications.pdf.
- Australian Drug Foundation, Victorian Minister for Health. "Amphetamines Fact Sheet," 2007 ed.: www.betterhealth.vic.gov.au/bhcv2/bhcarticles.nsf/pages/Amphetamines.
- Physicians' Desk Reference, 58th ed. Montvale, NJ: Thomson PDR, 2004.
- Johns Hopkins Medicine, Health Alerts, "Heart Attack: Symptoms and Remedies": www.johnshopkinshealthalerts.com/symptoms_remedies/heart_attack/83-1.html#3 (2008).
- U.S. Food and Drug Association, Center for Drug Evaluation and Research. "Public Health Advisory for Adderall and Adderall XR", 02/09/2005: www.fda.gov/Drugs/DrugSafety/PublicHealthAdvisories/ucm051672.htm.
- Adderall XR Medication Guide, Rev. 03/2009: www.adderallxr.com/pdf/AXR_FPI.pdf.
- Sadock, B.J., et al. Kaplan and Sadock's Synopsis of Psychiatry: Behavioral Sciences/Clinical Psychiatry (Synopsis of Psychiatry), 10th ed. Philadelphia, PA; Lippincott Williams & Wilkins, 2007.
- American Psychiatric Association, Diagnostic and Statistical Manual of Mental Disorders. 4th ed. Washington, DC, 2000, as cited above.
- S., L.K., et al. "Adderall-Induced Psychosis in an Adolescent," The Journal of the American Board of Family Medicine. Vol. 15 No. 6, Nov-Dec 02: www.jabfm.org/cgi/reprint/15/6/498.pdf.
- Gorman, Jack M. The Essential Guide to Psychiatric Drugs—Rev. and updated, 4th ed. New York, NY: St. Martin's Press, 2007.
What do Amphetamines Include?
| BRAND NAME | GENERIC NAME |
|---|---|
| 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] |
|
|
What is the most important information I should know about ADDERALL XR?
ADDERALL XR is a stimulant medicine. The following have been reported with use of stimulant medicines [AMPHETAMINES].
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.
How much do the “neuro-enhancing” drugs really help? And there's the question of what we mean by “smarter.”
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.”
Could enhancing one kind of thinking exact a toll on others?
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).
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