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. 1982 Nov-Dec;22(11-12):499-504.
doi: 10.1002/j.1552-4604.1982.tb02642.x.

The use of vital and morbidity statistics for the detection of adverse drug reactions and for monitoring of drug safety

The use of vital and morbidity statistics for the detection of adverse drug reactions and for monitoring of drug safety

P D Stolley. J Clin Pharmacol. 1982 Nov-Dec.

Abstract

PIP: Several examples of the use of vital statistics in drug epidemiology are described. The death rates for asthma remained stable from about 1860-1960 in the UK, about 0.5/100,000. In 1961 the rates began to rise, and after 1967 they declined; in the 1970s the rates almost approached pre-epidemic levels. The rates were found to vary with the use of isoproterenol-containing nebulizers. Investigations into the relationship between thromboembolism pulmonary embolism, and myocardial infarction and oral contraceptive (OC) usage showed an increase in death rates beginning after the introduction of OCs in 1960-61 in women at risk. Subacute myelo-optic neuropathy was an unexplained disease until Japanese investigators linked its occurrence to ingestion of the halogenated hydroxyquinoline drugs used to treat nonspecific gastroenteritis; seasonal outbreaks of the disease were linked to seasonal gastroenteritis. Animal experiments conclusively linked the drug to the disease. A Swedish report implicated the antihypertensive drug methyldopa as a possible cause of cancer of the biliary ducts. Links between thalidomide and phocomelia, saccharin or cyclamates and bladder cancer, diethylstilbestrol and vaginal cancer, and estrogens and endometrial cancer are discussed. Drug-monitoring systems, the collection of vital statistics and observations by clinicians all contribute to understanding drug-induced disease. Changes in disease incidence or emergency of new syndromes in areas where certain drugs are heavily used should be compared to areas where they are seldom used.

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