Adverse drug reactions and death. A review of 827 cases.

A study of 827 cases of adverse drug reactions (ADRs) in which autopsies were done was carried out to determine the relative frequency of drugs that caused adverse reactions, their sites of action, and the variety of pathologic processes induced by them. Because a variety of nondrug factors played critical roles in generating many of the ADRs, these 827 cases were divided into seven groups. Only one of these groups (25% of the total) met the criteria of ADRs in the usual definitional sense and were also lethal. The validity of the diagnoses of both the ADRs and the basic diseases being treated was strengthened by the addition of morphologic findings to the data base and by the use of an analytic algorithm that was specifically developed for and directed to the evaluation of ADRs.