The premarketing development program for ADDERALL XRª included exposures in a total of 685 participants in clinical trials (615 patients, 70 healthy adult subjects). These participants received ADDERALL XRª at daily doses up to 30 mg. The 615 patients (ages 6 to 12) were evaluated in two controlled clinical studies, one open-label clinical study, and one single-dose clinical pharmacology study (N= 20).
Safety data on all patients are included in the discussion that follows. Adverse reactions were assessed by collecting adverse events, results of physical examinations, vital signs, weights, laboratory analyses, and ECGs.
Adverse events during exposure were obtained primarily by general inquiry and recorded by clinical investigators using terminology of their own choosing. Consequently, it is not possible to provide a meaningful estimate of the proportion of individuals experiencing adverse events without first grouping similar types of events into a smaller number of standardized event categories.
In the tables and listings that follow, COSTART terminology has been used to classify reported adverse events. The stated frequencies of adverse events represent the proportion of individuals who experienced, at least once, a treatment-emergent adverse event of the type listed.
Adverse events associated with discontinuation of treatment: In two placebo-controlled studies of up to 5 weeks duration, 2.4% (10/ 425) of ADDERALL XRª treated patients discontinued due to adverse events (including 3 patients with loss of appetite, one of whom also reported insomnia) compared to 2.7% (7/ 259) receiving placebo. The most frequent adverse events associated with discontinuation of ADDERALL XRª in controlled and uncontrolled, multiple-dose clinical trials (N= 595) are presented below. Over half of these patients were exposed to ADDERALL XRª for 12 months or more.