20 Deaths Linked to Adderall XR
as reported by Associated Press and Bloomberg News on February 10, 2005
Photo: Matt Jeacock
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 XR Side Effects and Warnings
Updated August 16, 2008
Amphetamine/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.
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.
Description
Adderall and Adderall XR are powerful blends of four amphetamines that includes Dexedrine and Benzedrine. Each contains:
| EACH ADDERALL TABLET CONTAINS: |
5 mg |
7.5mg |
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 |
12.6mg |
18.8 mg |
| 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.
SOURCE: 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."
