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Alert for Healthcare
Professionals
Adderall and Adderall XR (amphetamine)
FDA Alert [08/2005]: Health Canada Announces Return of Adderall to the Canadian Market
Adderall will return to the Canadian market for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) (see alert of 02/09/05 below). The Canadian Product Monograph will be revised to include warnings about the misuse of Adderall, and that Adderall generally should not be used in patients with structural cardiac abnormalities.
FDA Alert [02/2005]: Health Canada Suspends Marketing of Adderall
Health Canada has suspended marketing of Adderall XR (extended
release) from the Canadian market due to concern about reports of
sudden unexplained death (SUD) in children taking Adderall and
Adderall XR. SUD has been associated with amphetamine abuse and
reported in children with underlying cardiac abnormalities taking
recommended doses of amphetamines, including Adderall and Adderall
XR. In addition, a very small number of cases of SUD have been
reported in children without structural cardiac abnormalities taking
Adderall. At this time, FDA cannot conclude that recommended doses
of Adderall can cause SUD, but is continuing to carefully evaluate
these data.
Recommendations
FDA is
currently examining the data on these cases occurring in children
who are using Adderall as recommended. As a precaution, FDA
recommends that Adderall products not be used in children or adults
with structural cardiac abnormalities.
Data Summary
A review of the
data from the FDA's Adverse Event Reporting System database for the
years 1999 through 2003 identified 12 cases of sudden death in
pediatric patients (1 to 18 years of age) who were being treated for
ADHD with Adderall or Adderall XR (see table for description of
cases).
Characteristics of domestic pediatric
sudden death cases reported during past five years (n=12)*
Age: |
7-16 years (mean 12. years) |
Gender: |
12 male, 0 female |
Suspect drug: |
Adderall or Adderall XR |
Total daily dose: |
10 mg (1), 20 mg (5), 30 mg (1), 40 mg (1), 50
mg (1) , NR (3) |
Duration of therapy: |
1 day – 8 years (range) |
Autopsy: |
yes (11), not mentioned or not done (1) |
Cardiac structural abnormalities
|
aberrant origin of coronary artery (1),
idiopathic hypertrophic subaortic stenosis (1), bicuspid aortic
valve (1), cardiac hypertrophy (2) |
Other risk factors: |
unexplained increase or toxic amphetamine level
(2), family history of ventricular arrhythmia (1), extreme
exercise and dehydration (1) |
Concomitant meds: |
none mentioned (9), 1 med (3) |
Year reported |
999 (0), 2000 (2), 2001 (6), 2002 (2), 2003 (2) |
*numbers in parentheses represent count of cases
Five of the 12
pediatric sudden death cases described cardiac risk factors
including undiagnosed cardiac abnormalities (e.g., aberrant origin
of coronary artery, bicuspid aortic valve, idiopathic hypertrophic
subaortic stenosis). Seven occurred in children without such
abnormalities, including 1 with a positive family history of
ventricular arrhythmia. Several of the cases were complicated by
other illness, and very rigorous exercise. Unusual and unexplained
accumulation of drug resulting in toxic levels during usual
therapeutic dosing also appears to have played a role in several of
the pediatric sudden death cases. The rare occurrence of sudden
death during stimulant therapy of ADHD deserves continued
evaluation. SUD as a possible effect of amphetamines should be
considered in the assessment of benefit versus risk during
therapeutic decision-making for individual patients. In the
pediatric population, potential risk factors include cardiac
abnormalities that may be undiagnosed, positive family history for
ventricular arrhythmias, and as yet unidentified factors that
may cause excessive levels of stimulant to accumulate in children
who are taking apparently normal doses.
An update and
further analyses of the data are currently in progress.
Report serious adverse events to FDA's MedWatch at
1-800-FDA-1088; or
http://www.fda.gov/medwatch/report/hcp.htm
Questions? Call Drug Information, 1-888-INFO-FDA
(automated) or 301-827-4570
druginfo@fda.hhs.gov
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Date created: February 9, 2005; updated September 23, 2005 |
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