FDA sits and waits amid Adderall deaths. Many are aware of the dangerous side-effects of amphetamines, especially when they are used to treat children with attention-deficit/hyperactivity disorder (ADHD). Yet, it has taken 20 sudden deaths and 12 fatal strokes to jolt Health Canada, the Canadian health-regulatory body, into action, suspending sales of Adderall, the extended-release antihyperactivity drug linked to the fatalities. The worldwide death count is 16 children (14 sudden deaths, 2 strokes) between 1999 and 2003.
That US regulatory body is taking a 'wait-and-see' approach in response to the reports, arguing that as the rate of sudden death in pediatric patients treated with Adderall is based on approximately 30 million prescriptions . . . 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.
In other words, the FDA is telling parents who may have lost their children to Adderall that there aren't enough deaths yet for the agency to take it seriously (www.fda.gov/medwatch/; 10 February 2005).