Adderall and Adderall XR Public Health Advisory
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.
THE ABOVE IS FDA DRUG INFORMATION