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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:
http://www.fda.gov/cder/drug/advisory/adderall.htm
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:
http://www.fda.gov/cder/drug/InfoSheets/HCP/AdderallHCPSheet.pdf
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. |
