Operational criteria for adverse drug reactions in evaluating suspected toxicity of a popular scabicide

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Abstract
A recently developed algorithm for the diagnosis of adverse drug reaction (ADR) was used to study the quality of evidence in reported cases of ADR to 1% .gamma. BHC, a popular scabicide and pediculicide currently under suspicion as a cause of CNS toxicity, especially in children. Of the 53 reported cases of alleged toxicity, 37 were associated with lindane insecticide (> 1% BHC), which is not a pharmaceutical preparation. Of these 37 cases, 34 scored as definite or probable reactions on the algorithm. Of the 26 reports associated with the drug, 1% BHC, none scored as definite and only 6 as probable ADR. Of these 6 probable cases, 5 represented inappropriate application or unintended ingestion. The use of rigorous operational criteria such as those developed in this algorithm permits a scientifically disciplined assessment of whether or not a drug has been fairly indicated, and also provides valuable clinical information about other aspects of suspected drug toxicity.