Attention Deficit

Medical News Today reports that ADDERALL XR® from Shire Pharmaceuticals Group plc has been indicated for use among adolescents aged 13 to 17 with attention deficit hyperactivity disorder (ADHD) by the US Food and Drug Administration. (ADHD - FDA expands indication for ADDERALL XR® (CII) confirming safety and efficacy in adolescents)

The drug was originally approved for treatment in ADHD children aged 6 to 12 years in October of 2001 and since August 2004 in adults 18 years and older. ADDERALL XR is currently the most commonly prescribed brand of ADHD medication in the United States.

"There has long been an unmet need for ADHD research and treatment among the adolescent population despite an increasing awareness of ADHD’s potential impact on quality of life. Therefore, approval of an ADHD treatment for this underidentified age group is an important milestone," explained Dr. Timothy Wilens of Massachusetts General Hospital. "The symptoms of ADHD often continue past childhood into adolescence and adulthood, where they can have a significant impact on an individual’s family, academic performance, and overall quality of life. Stimulant therapies are effective and generally well tolerated, and have been used medically in patients for more than 60 years."

This directly contrasts with Health Canada’s decision to remove ADDERALL from the Canadian market (Health Canada Suspends ADHD drug Adderall XR) due to 20 or so deaths associated with the drug’s use. According to Shire Pharmaceuticals, “ADDERALL XR may not be right for everyone. ADDERALL XR was generally well tolerated in clinical studies. The most common adverse events in pediatric trials included loss of appetite, insomnia, abdominal pain, and emotional lability. The most common side effects in the adolescent trial included loss of appetite, insomnia, abdominal pain, and weight loss. The most common adverse events in the adult trial included dry mouth, loss of appetite, insomnia, headache, and weight loss.

The effectiveness of ADDERALL XR for long-term use has not been systematically evaluated in controlled trials. As with other psychostimulants indicated for ADHD, there is a potential for exacerbating motor and phonic tics and Tourette’s syndrome. A side effect seen with the amphetamine class is psychosis. Caution also should be exercised in patients with a history of psychosis.”

One must wonder whether the side effects are worth using a drug whose efficacy has not been evaluated for long-term use. Terms like ‘emotional lability’ appear as an attempt to obfuscate. It is much clearer to say, ‘emotional change or breakdown.’