ProCentra is a new name for an old psychiatric drug known to have a high potential for severe dependence. Now in bubblegum-flavored liquid for small children and promoted by the drug-maker as “easier to swallow.”
DEA Schedule II Control Substance means this drug has a “high potential for abuse” that “may lead to severe psychological or physical dependence,” and the federal government sets limits on the amount that may be manufactured each year.
FDA “Black Box” Warning
The Food and Drug Administration (FDA) requires the following “black box” warning on all amphetamine drugs, including ProCentra, which means that medical studies indicate ProCentra 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 appears on the manufacturer's wholesale packaging and is the strongest alert the FDA can require. (Emphasis added.)
Description
ProCentra is an amphetamine in a clear, sugar-free, bubblegum-flavored liquid solution. Available in 16 fluid oz. bottles, each 5mL contains 5mg dextroamphetamine.
Procentra (as with all amphetamines) works by by initiating the acute stress response (“fight or flight” response). The central nervous system prepares the body for physical action by creating physiological changes as if it were stressed or under threat. These changes include:
The release of adrenaline, raises cortisol levels and other stress hormones
Increased heart rate and blood pressure
Redirected blood flow into the muscles and away from the brain
Small doses of ProCentra 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 typically leaves the user feeling nauseous, irritable, depressed and extremely exhausted.
Do Not Use If
Your child has not tried other psychotherapy, has high blood pressure or any form of heart disease, is very nervous or has severe insomnia, has a history of addiction to drugs or alcohol, or has Tourette syndrome. Do not combine with monoamine oxidase inhibitors.
ProCentra is not recommended for use as an anorectic (loss of appetite) agent in children under 12 years of age.
Tolerance Warning
Tolerance to the anorectic (loss of appetite) effect usually develops within a few weeks. When this occurs, the recommended dose should not be exceeded in an attempt to increase the effect; rather, the drug should be discontinued (see DEPENDENCE, TOLERANCE AND WITHDRAWAL).
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)
“High doses and long-term use of amphetamines are associated with erectile disorder and other sexual dysfunctions.”
ABOVE: American Psychiatric Association's Diagnostic and Statistical Manual of Mental Disorders as cited in Kaplan and Sadock's Synopsis of Psychiatry (2007).
Overdose Side Effects
Dextroamphetamine drugs have been extensively abused. Extreme psychological dependence and severe social disability have resulted. Abuse of dextroamphetamine 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
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.
Amphetamine-Induced Psychosis
Induction of schizophrenic-like states in children on prescribed doses of stimulant medications, including amphetamines, have been observed, though not as well documented as with amphetamine abusers, according to The Journal of the American Board of Family Medicine.
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."
“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. “Drug Fact Sheet: Amphetamines,” undated, retrieved January 15, 2013 www.justice.gov/dea/druginfo/drug_data_sheets/Amphetamines.pdf.
Dependence, Tolerance and Withdrawal
Amphetamine drugs have been extensively abused. Tolerance, extreme psychological dependence, and severe social disability have occurred. There are reports of patients who have increased the dosage to many times that recommended. Abrupt cessation following prolonged high dosage administration results in extreme fatigue and mental depression; changes are also noted on the sleep EEG. Manifestations of chronic intoxication with methamphetamine include severe dermatoses [skin disease], marked insomnia, irritability, hyperactivity, and personality changes. The most severe manifestation of chronic intoxication is psychosis often clinically indistinguishable from schizophrenia.
Tolerance 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 ProCentra 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 amphetamines (ProCentra) 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, [amphetamine] 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. Amphetamine “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.”
ProCentra (amphetamines) produces gross reductions in blood flow to the brain.
Decreased blood flow to the brain plays a major role in cognitive impairment, dementia and Alzheimer's.
ABOVE: Abreu BE, et al. Influence of amphetamine sulfate on cerebral metabolism and blood flow in man. J Pharm Sci, 1949;38:186–188. Mazza M, et al. Primary cerebral blood flow deficiency and Alzheimer's disease: shadows and lights. Journal of Alzheimer's Disease 2011;23(3):375-89.
What is the most important information I should know about PROCENTRA?
The following have been reported with use of PROCENTRA 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 PROCENTRA.
Your doctor should check you or your child's blood pressure and heart rate
regularly during treatment with PROCENTRA.
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 PROCENTRA.
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 PROCENTRA, especially seeing or hearing things that are not real, believing things that
are not real, or are suspicious.
ABOVE: ProCentra Medication Guide, Rev. 01/2009.
What are the differences between the various Amphetamines?
“All amphetamines 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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Most people may not know that Strattera (atomoxetine) appears to cause unsatisfactory sexual function (decreased libido, ejaculatory problems and impotence). [More]
Drug Enforcement Administration, US Department of Justice. “Stimulants,” Drugs of Abuse Publication. National Drug Intelligence Center, 2005 ed.
Drug Enforcement Administration, US Department of Justice. “Drug Fact Sheet: Amphetamines,” undated, retrieved January 15, 2013 www.justice.gov/dea/druginfo/drug_data_sheets/Amphetamines.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.: 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.
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.
ProCentra Medication Guide, Rev. 01/2009.
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.
