Deaths from Drugs. An Analysis of Drug‐Induced Deaths Reported to the Swedish Adverse Drug Reaction Committee During a Five‐Year Period (1966–1970)

Fifty years of pharmacovigilance – Medicines safety and public health

“…Spontaneous reporting is based on clinical judgement, which draws preferential attention to rare events, so that a rare disease is more likely to be reported than more common conditions. The conditions that topped the lists of spontaneous reporting in the sixties and in the early seventies were almost invariably type B ADRs with a low incidence (1 to 20 per million per year) – blood dyscrasias, acute hypersensitivity reactions, acute liver failure, and severe cutaneous reactions . Regulatory action also concentrated on rare type B ADRs .…”

Diagnosis of Acute Drug-Induced Liver Injury

“…In voluntary reporting surveys, acute hepatotoxicity accounts for approximately 6 to 8% of the total number of adverse drug reactions (B6ttiger et al 1974(B6ttiger et al , D0ssing & Andreasen 1982. Only about 2% of jaundiced cases admitted to a general hospital and 5 to 8% admitted to a liver unit had druginduced liver disease (Knill-Jones et at.…”

Detection of drug‐induced disease.

“…Other spontaneous reporting systems have also produced valuable information particularly from Sweden where reporting of suspected adverse effects is compulsory and Finland which has an excellent record-linkage system with other bodies of data. Examples from the Swedish agency include details of drug-related deaths (Bottiger, Norlander, Strandberg & Westerholm, 1974), leucopenia (Westerholm & Reizenstein, 1970) and thrombocytopenia (Bottiger & Westerholm, 1973), and from the Finnish agency include the impressive speed with which agranulocytosis was recognized after use of the drug clozapine and the drug removed from the market (Anderman & Griffiths, 1977; Idanpaan-Heikkila, Alhava, Olkinuora . Using the data from such agencies it is possible for certain rare events to obtain an estimate of the incidence of the condition in the community (Idanpaan-Heikkila Inman, 1977b).…”