After recommendations from the FDA, the makers of Adderall XR have upgraded the drug’s black-box label. The “black-box” section of prescription drug labeling is where the most serious side effects of drugs must be listed. Adderall XR is the best-selling prescription drug for the treatment of attention-deficit hyperactivity disorder (ADHD). The FDA urged all manufacturers of ADHD drugs to warn patients that these products may cause psychological side effects including psychosis, bipolar illness and aggression. Misuse or abuse of ADHD drugs can also cause serious cardiovascular side effects such as heart attack, stroke and sudden cardiac death. On August 21, 2006, Shire PLC announced it would add language to include warnings that misuse of Adderall XR could lead to sudden death.

An estimated five million people use ADHD drugs in the U.S., with over three million users under 19 years old. Adderall XR was pulled from the prescription drug market in Canada in February 2005 after 20 patient deaths were reported, but it was returned to the market in August of that year. In May 2006, Health Canada, the oversight agency similar to the U.S. FDA, strengthened Adderall XR’s warning label for patients in Canada.

Source: Shannon Pettypiece and Justin Blum, “Glaxo, Shire Strengthen Risk Warnings on ADHD Drugs,” Bloomberg.com, August 21, 2006.