Philadelphia, US – August 29, 2005 – Shire Pharmaceuticals Inc. announced today that Health Canada, the Canadian drug regulatory agency, reinstated marketing authorization of ADDERALL XR® (mixed salts of a single-entity amphetamine product) in Canada for the treatment of attention deficit hyperactivity disorder (ADHD), effective Friday, August 26, 2005. The reinstatement follows the recommendation from the New Drug Committee (NDC), which Health Canada appointed at Shire’s request to review the drug's safety. The NDC is comprised of three highly qualified, independent experts in the fields of pediatric cardiology, pediatric development and behavioral problems, and pharmacoepidemiology.
“Following a comprehensive review of the safety data on ADDERALL XR, Health Canada has decided that ADDERALL XR will return to the Canadian market,” said Raymond Pratt, M.D., Vice President, Global Clinical Medicine, Shire Pharmaceuticals Inc. “Shire has stood behind the safety of ADDERALL XR and is very pleased that Health Canada responded to the advice of experts and concluded that this medication should be available to patients in Canada again. ADDERALL XR is effective and generally well-tolerated when prescribed and administered as recommended and the reinstatement benefits both patients and physicians in Canada who depend on this medication.”
Health Canada’s announcement occurs less than one month after the US Food and Drug Administration (FDA) confirmed the safety and efficacy of ADDERALL XR by expanding the pediatric and adult indication to include the treatment of adolescents aged 13 to 17 with ADHD. ADDERALL XR is currently the most commonly prescribed brand of ADHD medication in the United States.
“The return of this medication provides Canadian health care professionals with an effective treatment option for patients who suffer from the symptoms of ADHD,” stated Joseph Biederman, M.D., Harvard Medical School, Boston, Massachusetts. “Amphetamines have been used medically for almost 70 years. If untreated, the symptoms of ADHD often continue past childhood into adolescence and adulthood, where they can significantly impact an individual's family, academic performance, job and overall quality of life.”
The NDC recommendation for the reinstatement of ADDERALL XR in Canada, supported by both Health Canada and Shire, includes revisions to the product monograph and patient leaflet that Shire previously proposed in November 2004 to make it consistent with the US package insert. A product monograph is the Canadian equivalent of a US package insert required by the FDA.
Health Canada approved ADDERALL XR in January 2004 but suspended marketing authorization in February 2005 because of concerns about the drug’s safety. Following this action, the US FDA posted a statement on its Web site confirming that “FDA does not feel that any immediate changes are warranted in the FDA labelling or approved use of this drug based upon its preliminary understanding of Health Canada's analyses of adverse event reports and FDA's own knowledge and assessment of the reports received by the agency.”
Since 1996, over 43 million prescriptions have been written for branded Adderall or Adderall XR.
ADHD affects approximately 3 to 7 percent of all school-age children and is considered the most commonly diagnosed psychiatric disorder in children and adolescents. ADHD can have a profound effect on a child’s quality of life and can be serious enough to interfere beyond academics, leading to problems maintaining friendships, difficulties focusing on sports or other after-school activities, and challenges in relating well with other family members.
Untreated ADHD has long-term adverse effects on academic performance, vocational success and social-emotional development. Evidence also suggests that many with untreated ADHD may be at risk for other problems, such as drug abuse, anti-social behavior and poor self-esteem. As they age, up to 65 percent of adolescents with ADHD may still exhibit symptoms into adulthood.
