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On February 9, 2005, Health Canada suspended all sales of Adderall XR after data collected by manufacturer Shire Pharmaceuticals linked the drug to 12 sudden deaths in American children between the years of 1999 to 2003.[7] Further research, however, found little data suggesting use of Adderall resulted in an increased risk of cardiac defect. Of the twelve sudden deaths positively linked to pediatric Adderall users during the four year period, five had known pre-existing cardiac conditions, one died after strenuous exercise in 110 degree heat and two had levels suggestive of an overdose. Given the more than 37,000,000 prescriptions for Adderall filled during the four years, the U.S. Food and Drug Administration could find no increased risk of sudden death among Adderall users beyond the normal rate of the general population.[8][9] In August 2005, Health Canada followed the committee report of three independent physicians and lifted the ban on Adderall XR.[10][11] Given that persons with ADHD are more likely to engage in risky or dangerous behavior, it has been suggested that stimulant medications for persons with ADHD may actually result in lower incidence of premature death.[12] The use of Adderall is generally not advised in those persons with pre-existing cardiac or mental illnesses. It is also not advised in persons who have a history of drug abuse.[13] Although FDA safety advisors voted 8 to 7 to issue a black box warning, the FDA’s pediatric advisory committee refused to give the drug its most severe black box warning in March 2006.[14] A Black Box Warning regarding amphetamine abuse potential is in place, however.
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