Canada suspended sales of Adderall XR on February 9, 2005, citing concerns regarding 20 reports of sudden death in children and adults taking the drugs, all of them in the United States. (Adderall XR is the only form sold in Canada; Adderall is also available in the US along with the XR form). According to various reports, about 12 to 14 of the deaths were in children. The US FDA has left the drug on the US market. It cites 12 child deaths between 1999 and 2003, and it believes that the deaths cannot be attributed to the drug itself. They have released data on the deaths and indeed, many seem unrelated: five patients had structural heart defects, one had diabetes and one had an apparent heat stroke while at a boot camp. The FDA also points out that the rate of death among young people taking Adderall from 1999 to 2003 was 0.5 deaths per 100,000 patient-years, which is lower than the estimated rate in the general population of young people of 1.3 or higher, according to one study. The FDA has also decided not to change the labeling on the drug at this time; last year, the label was modified to indicate using the drug with caution in people with underlying structural heart defects.
How should we interpret this? First of all, the lesson is made again that every drug, every immunization, every medical procedure, has benefits and risks, and should be used only when the benefits outweigh the risks. Our culture currently desires a drug, a treatment, for almost every condition, and we too easily overlook or forget that these treatments have side effects, some of which are unknown. Every treatment decision should be based on potential benefits vs. potential risks. Unfortunately, the risks of many drugs are unknown, particularly the long-term effects of newer drugs.
Should children taking Adderall or Adderall XR stop the medication? At this point, probably not. The FDA feels at this time that the drug is safe and that it should remain on the market. And while the system in the United States for reporting and tracking drug side effects is far from perfect, it seems to work reasonably well, and the FDA is continuing to monitor the situation and to investigate the safety of Adderall and Adderall XR.
Public health advisory from the FDA
FDA information on Adderall and Adderall XR
