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FDA Warns of Psychiatric Adverse Events from ADHD Medications

Medications commonly used for ADHD (attention deficit/hyperactivity disorder) may carry an increased risk of triggering some of the same psychiatric symptoms as those seen in schizophrenia and mood disorders, even in patients who did not have previous psychiatric problems. These psychiatric symptoms include psychotic episodes marked by auditory or visual hallucinations, paranoia, delusions, and mania.
ADHD is a condition that affects approximately 10 percent of the pediatric population in the U.S., according to estimates by the Centers for Disease Control and Prevention (CDC). The primary symptoms of ADHD are inattention, hyperactivity, and impulsivity. Individuals with ADHD may have difficulty functioning in work or school, and suffer with issues of low self-esteem or depression.

On February 21, 2007, the Food and Drug Administration issued a requirement that ADHD drug manufacturers inform patients about the associated adverse psychiatric symptoms (FDA Asks Attention-Deficit Hyperactivity Disorder (ADHD) Drug Manufacturers to Develop Patient Medication Guides). The FDA warned about psychotic events from the use of ADHD medications in its 2006 briefing “Adverse Events Associated with Drug Treatment of ADHD: Review of Post marketing Safety Data,” presented to the Pediatric Advisory Committee: “The most important finding of this review is that signs and symptoms of psychosis or mania, particularly hallucinations, can occur in some patients with no identifiable risk factors, at usual doses of any of the drugs currently used to treat ADHD.”

Stimulant medications prescribed for ADHD include Focalin (dexmethylphenidate hydrochloride), Adderall (amphetamine), Dexedrine (dextroamphetamine), Vyvanse (lisdexamfetamine) and Ritalin (methylphenidate hydrochloride). All these ADHD medications are tested as part of the Rxight® genetic testing panel, which is designed to analyze your body’s ability to metabolize these and over 200 other common prescription and over-the-counter medications.

The Rxight® pharmacogenetic test is grounded in the analysis of a set of genes and their alleles to determine how you will metabolize different medications and assimilate them into the body based on your unique genotype. If you are a so-called “fast metabolizer” of a particular medication, you process the drug and therefore may require a higher than normal dose to achieve therapeutic benefit. Conversely, if you are a “slow metabolizer” you are prone to toxic effects from the medication and its metabolites building up in your system and causing potentially serious adverse reactions, such as a stimulant intoxication in the case of ADHD medications.

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