BY OUR PHARMA CORRESPONDENT
31 August, 2005: The Canadian drug regulator, Health Canada has decided to reinstate the marketing authorization of Shire Pharmaceuticals drug Adderall XR to treat Attention Deficit and Hyperactivity Disorder (ADHD), in Canada effective August 26, 2005.
This announcement follows the acceptance by Health Canada of the recommendations from the New Drug Committee (NDC), which was appointed by Health Canada at Shire’s request to review the February 9, 2005 suspension in Canada , Shire Pharmaceuticals Group plc said in a press release.
The NDC, comprised of three highly qualified, independent experts in the fields of pediatric cardiology, pediatric development and behavioral problems, and pharmacoepidemiology, examined the scientific evidence made available to them by both Shire and Health Canada.
The NDC recommendation for the reinstatement of Adderall XR in Canada, supported by both Health Canada and Shire, includes adoption of the revisions to the Canadian Product Monograph and patient leaflet that Shire previously proposed in November 2004. The NDC has also recommended that Shire distribute a Dear Healthcare Professional Letter and support independent continuing medical education for Canadian physicians to reinforce their understanding of the issues around sudden/cardiac death in the general pediatric population.
Health Canada has agreed to work with Shire to implement the recommendations of the NDC and Shire will work diligently to make Adderall XR available to Canadians in the coming weeks, the release stated.
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 liability. 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. Abuse of amphetamines may lead to dependence. Misuse of amphetamine may cause sudden death and serious cardiovascular adverse events.
Adderall XR generally should not be used in children or adults with structural cardiac abnormalities. The drug is contraindicated in patients with symptomatic cardiovascular disease, moderate to severe hypertension, hyperthyroidism and glaucoma, known hypersensitivity to this class of compounds, agitated states, history of drug abuse, or current or recent use of MAO inhibitors. The drug should be prescribed with close physician supervision, the release alerted.
Shire Pharmaceuticals Group plc (Shire) is a global specialty pharmaceutical company currently focuses on developing and marketing products in the areas of central nervous system (CNS), gastrointestinal (GI), renal diseases and human genetics. Shire has operations in the world’s key pharmaceutical markets (US, Canada, UK, France, Italy, Spain and Germany) as well as a specialist drug delivery unit in the US.
BY OUR PHARMA CORRESPONDENT