Benefits vs. Risk: Adderall XR taken off market in Canada, 2-09-05

Citing 20 cases of sudden death of patients taking Adderall XR, the Canadian equivalent of our FDA suspended sales of this popular ADHD medication. The FDA in the U.S. has reports of 12 sudden deaths in children over a 5-year period where 30 million prescriptions for Adderall were written. It is the current opinion of our FDA that this rate of sudden death is not higher than would be expected in the general population if not on Adderall. Half of the deaths were in patients that had heart defects; one heat exhaustion/heat stroke and most of the others had either other serious health problems or were on other concomitant medications. At this time the FDA does not believe there is any significant risk except possibly in patents with congenital heart defects or other serious compromising medical conditions, such as uncontrolled high blood pressure. The Canadian number of 20 deaths apparently includes some adults, but most, if not all, had multiple complicating factors. It is my opinion that with the few exceptions mentioned above, the benefits of Adderall XR far outweigh any potential risk, and I am advising my patients that there�s no need to discontinue the med or have undue concern. If you want additional information go to FDA.gov or Shire.com
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