The Practitioner's Role in Detection of Adverse Drug Reactions

Abstract

A single letter or telephone call can be lifesaving! A few years ago, a clinician telephoned the Food and Drug Administration to voice his concern about potential dangers resulting from the use of benzyl alcohol in the treatment of neonates. Solutions used to flush intra-arterial lines contained small amounts of benzyl alcohol. This minimal amount was a lethal dosage for some of the tiny patients. The suspicions of the practicing pediatrician were correct, and his "spontaneous report" saved many lives. The dangers of using the drug ticrynafin were identified in a similar fashion, ie, by spontaneous telephone calls and letters from practicing physicians to the FDA. Accumulation of data from single case reports correctly identified serious liver damage as a potential danger of this agent, and the drug was removed from the market in the United States. Clinicians can provide invaluable data in the evaluation of drug effects in treating