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Public Health Advisory for
Adderall and Adderall XR
Health Canada, the Canadian drug regulatory agency,
has suspended the sale of Adderall XR in the Canadian market.
Adderall XR is a controlled release amphetamine used to treat
patients with Attention Deficit Hyperactivity Disorder (ADHD). The
Canadian action was based on U.S. post-marketing reports of sudden
deaths in pediatric patients.
Adderall XR is approved in the United States for the treatment of
adults and pediatric patients 6 years of age and older with ADHD,
and Adderall, the immediate-release formulation of the drug, is
approved for pediatric patients with ADHD. The Food and Drug
Administration (FDA) has been aware of these post-marketing cases,
and evaluated the risk of sudden death with Adderall prior to
approving the drug for treatment of ADHD in adults last year.
Of 12 total cases, five occurred in patients with underlying
structural heart defects (abnormal arteries or valves, abnormally
thickened walls, etc.), all conditions that increase the risk for
sudden death. Several of the remaining cases presented problems of
interpretation, including a family history of ventricular
tachycardia, association of death with heat exhaustion, dehydration
and near-drowning, very rigorous exercise, fatty liver, heart
attack, and type 1 diabetes mellitus. One case was reported three to
four years after the event and another had above-toxic blood levels
of amphetamine. The duration of treatment varied from one day to 8
years. The number of cases of sudden deaths reported for Adderall is
only slightly greater, per million prescriptions, than the number
reported for methylphenidate products, which are also commonly used
to treat pediatric patients with ADHD.
The FDA is continuing to evaluate these and other post-marketing
reports of serious adverse events in children, adolescents, and
adults being treated with Adderall and related products. 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
this reason, the FDA has not decided to take any further regulatory
action at this time. However, because it appeared that patients with
underlying heart defects might be at increased risk for sudden
death, the labeling for Adderall XR was changed in August 2004 to
include a warning that these patients might be at particular risk,
and that these patients should ordinarily not be treated with
Adderall products.
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Date created: February 9, 2005 |
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