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From: Shire Pharmaceuticals

February 11, 2005

Dear RxLink Pharmacist,

I am writing to clarify the recent news regarding Adderall XR (Mixed Salts of a Single-Entity Amphetamine Product), and Health Canada's decision to suspend sales of Adderall XR in Canada. We want to provide you with information about product safety when dispensing Adderall XR to your customers.

Below is important information that will assist you in understanding the situation:

-Over time, there have been rare reports of sudden death in patients taking Adderall and Adderall XR. None of these occurred in Canada. These reports are difficult to interpret and could not be directly or causally linked to Adderall XR, as many of these patients were taking various medications and many had pre-existing health issues. Regardless, as part of standard safety updates, Shire has regularly submitted these data to the FDA since the product has been approved.

-As a reminder, in August 2004, following FDA review of these safety data, Shire updated the product labeling for Adderall XR to include a warning about a risk of sudden death in patients with structural cardiac abnormalities and to strengthen the warning about the risks of misuse of amphetamine.

-The same data that were reviewed by the FDA were also reviewed by Health Canada. We strongly disagree with Health Canada's decision to suspend sales of Adderall XR in Canada. We agree with the FDA that many of the cases of sudden death were difficult to interpret considering poly-pharmacy and co-morbidity issues, and because of that, could not be directly or causally linked to Adderall XR.

Following Health Canada's decision, the FDA reaffirmed their position from August 2004 and does not believe that any additional changes are warranted to the product labeling for Adderall XR. As stated, by the FDA, "When one considers the rate of sudden death in pediatric patients treated with Adderall products based on the approximately 30 million prescriptions written between 1999 and 2003 (the period of time in which these deaths occurred), it does not appear that the number of deaths reported is greater than the number of sudden deaths that would be expected to occur in this population without treatment." For the full text of this FDA statement, please visit the following link:


We at Shire remain confident of the safety and efficacy of Adderall and Adderall XR when used in accordance with the product labels. Finally, I want to provide you with the FDA document developed for healthcare professional that reviews some of the cases of sudden death in greater detail, which will allow you to understand the complexity of many of these cases. To review this document, please visit:


Should you have any further questions please contact the Shire Medical Information Group at 800-828-2088.

Best regards,

David Mays, Pharm D., MBA, BCPS

Director, Medical Information

Important Safety Information

The most common adverse events in pediatric trials included loss of appetite, insomnia, abdominal pain, and emotional lability. 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 amphetamines may cause sudden death and serious cardiovascular adverse events. Adderall XR generally should not be used in children or adults with structural cardiac abnormalities. Adderall XR 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. Adderall XR should be prescribed with close physician supervision.


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