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Adderall XR Side Effects and Warnings
Generic Name: amphetamine mixed salts
Required “Black Box” Warning LabelAdderall 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.
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."
—Adderall.net
I have presented the above quote to show that a commonly prescribed and used medication must be considered in an informed way by those who use it for themselves or their children. This is the meaning of "informed consent" and is a necessary part of good clinical practice. My aim here is to increase awareness of a common disorder (DSM-5 states: 5% in children; 2.5% in adults) and a common treatment that has effects and side effects, sometimes not made clear.
FDA black box warning labels mean that medical studies indicate the drug carries a significant risk of serious or even life-threatening adverse effects. The bold warning label appears on wholesale packaging and is the strongest alert the FDA can require.
I found this alert astounding. Adderall is arguably one of the most frequently prescribed ADD and ADHD (attention deficit and attention-deficit/hyperactivity disorder) medications prescribed by doctors—pediatricians and psychiatrists. The new DSM-5 criteria for diagnosing ADHD requires fewer current symptoms, a significant decrease (65%) from the previous DSM-IV of two years ago.
A recent medical journal watch review stated “Using private insurance and Medicaid data from 2008 to 2014, researchers examined claims for children aged 2-5 years receiving care for ADHD. Roughly 55% of children received recommended psychological services (e.g., parent behavior training), while 75% had a prescription claim for ADHD medication.”
I remember reading an article in the British Medical Journal (BMJ 2013; 347:6172), “Attention-deficit/hyperactivity disorder: are we helping or harming? It made some of the following points:
1) Reducing the threshold for diagnosis devalues the diagnosis.
2) Overdiagnosis is possible because the criteria are subjective.
3) Commercial influence is a serious concern.
Last, it addressed factors such as social, political environment, educational funding and resources, disability services, and different treatment options.
While abuse and dependence are mentioned in the above quote, side effects are common: loss of appetite, weight loss, insomnia*, anxiety, nervousness, mood irritability, excitability, mood swings, and less often psychosis and delusions. It is common to see a child on a stimulant medication along with a sleeping pill or sedative.
I personally have seen about a dozen teenagers with symptoms of significant hair pulling and others with constant scratching to the point of removing skin and creating scabs. When the stimulant medication was removed, after about eight weeks, these symptoms went away and did not return.
If any medication is indicated, there are non-stimulant options from different drug classes that do not have these side effects (e.g., guanfacine or guanfacine ER, among others).
To be clear, doctors are ethically oriented to do no harm. To ensure excellent and quality patient care, careful diagnosis is required. This means distinguishing unfocused attentional concerns from impulsive, overactive behaviors that may be dangerous. The causation of each may be different. If they occur together, there may be multiple causes, some of which demand psychosocial and behavioral interventions. The specific age and age-range are critical to note because in early and mid-childhood healthy physical activity is developmentally expected. In the adolescent years, meticulous evaluation is important because so many other emotional and social (and substance abuse) issues may be at stake. In adulthood, the rational, informed assessment between patient and doctor may add greater clarity to presenting problems.
All these considerations are noteworthy. There are no "smart drugs" that increase intelligence. Many children, when tested, show uneven or lower IQ scores. Learning disabilities are commonly encountered. It is important not to ignore or to underestimate these facts. The remediation for these cognitive concerns is educational and academic, not psychopharmacologic. Side effects are often dangerous, particularly to the developing nervous systems and emotional lives of children and families.
* Becker SP1, Froehlich TE, Epstein JN. “Effects of Methylphenidate on Sleep Functioning in Children with Attention-Deficit/Hyperactivity Disorder.” J Dev Behav Pediatr. 2016 Jun;37(5):395-404.
On Twitter: @constantine123A
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