ProCentra is a new name for a 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.”
ProCentra Side Effects and Warnings
FDA “Black Box” Warning Label
The Food and Drug Administration (FDA) requires the following "black box" warning on all amphetamines, including ProCentra, which means that medical studies indicate these drugs carry a significant risk of serious, or even life-threatening, adverse effects.
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 NON-THERAPEUTIC USE OR DISTRIBUTION TO OTHERS, AND THE DRUGS SHOULD BE PRESCRIBED OR DISPENSED SPARINGLY.
MISUSE OF AMPHETAMINES MAY CAUSE SUDDEN DEATH AND SERIOUS CARDIOVASCULAR ADVERSE EVENTS.
ProCentra is an amphetamine in a clear, sugar-free, bubblegum-flavored liquid solution. Available in 16 fluid oz. bottles, each 5mL contains 5mg dextroamphetamine.
- Active Ingredient: dextroamphetamine sulfate.
- Inactive Ingredients: benzoic acid, citric acid anhydrous, purified water, sodium citrate hydrous, sodium saccharin, sorbitol solution, and artificial bubble gum flavor.
- Attention deficit disorder with hyperactivity
How ProCentra Works
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.
Amphetamines are not recommended for use as an anorectic (loss of appetite) agent in children under 12 years of age.
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
- Difficulty falling asleep (insomnia)
- Nervousness including agitation, anxiety and irritability
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)
- 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. (Methylphenidate drugs include: Concerta, Daytrana, Focalin, Metadate, Methylin, Quillivant, and Ritalin.) 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.”
The safety warning also raised concerns about links between priapism and amphetamine drugs, which include Adderall, Dexedrine, ProCentra and Vyvanse.
Overdose Side Effects
Amphetamine drugs 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:
- 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)
- 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.
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."
Dependence, Tolerance and Withdrawal
Amphetamine drugs have been extensively abused. Tolerance, extreme psychological dependance, 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 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 amphetamines can cause extreme fatigue and severe, even suicidal, depression in adult patients.
The effects of amphetamines and methamphetamine are similar to cocaine, but their onset is slower and their duration is longer.—U.S. Drug Enforcement Administration (DEA) fact sheet
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.”