Recognizing idiosyncratic adverse drug reactions in children: A practice imperative

Abstract

In North America, adverse drug reactions (ADRs) continue to be a major cause of morbidity, hospital admission and death (1). The above statement runs counter to the common assumption of health care professionals and the general public that, when drugs are approved for marketing, their safety has been clearly determined by the Federal Drug Administration in the United States and the Therapeutic Products Programme in Canada. There are some limitations to the drug approval process. With most drugs, approval for marketing is granted following phase III clinical trials. However, these trials are typically short in duration, are conducted in relatively small numbers of patients (usually involving hundreds, not thousands of patients) under conditions that are not clinically routine, and often exclude patients with co-morbidities and co-medications (2). Usually, early regulatory trials exclude children (3). Under the above investigative conditions, the most common ADRs will be observed (2) usually in adult populations exclusively; less common ADRs may be missed altogether.