Morbidity studies

Studies in Phase IV are all studies (other than routine surveillance) performed after drug approval and related to the approved indication. They are studies that were not considered necessary for approval but are often important for optimizing the drug s use. They may be of any type but should have valid scientific objectives. Commonly conducted studies include additional drug-drug interaction, dose-response or safety studies, and studies designed to support use under the approved indication, for instance, mortality/morbidity studies, epidemiological studies. 

Ott MG, Zober A. 1996. Morbidity study of extruder personnel with potential exposure to brominated dioxins and furans. IE Results of clinical laboratory studies. Occup Environ Med 53(12) 844-846. 

Lathrop GD, Wolfe WH, Albanese RA, et al. 1984. An epidemiological investigation of health effects in Air Force personnel following exposure to herbicides Baseline morbidity study results. USAF School of Aerospace Medicine, Brooks Air Force Base, Texas. 

Hepatic Effects. Chromium(VI) has been reported to cause severe liver effects in four of five workers exposed to chromium trioxide in the chrome plating industry. Derangement of the cells in the liver, necrosis, lymphocytic and histiocytic infiltration, and increases in Kupffer cells were reported. Abnormalities in tests for hepatic dysfunction included increases in sulfobromophthalein retention, gamma globulin, icterus, cephalin cholesterol flocculation, and thymol turbidity (Pascale et al. 1952). In a cohort of 4,227 workers involved in production of stainless steel from 1968 to 1984, excess deaths were observed from cirrhosis of the liver compared to expected deaths (0/E=55/31.6) based on national rates and matched for age, sex, and calender time having an SMR of 174 with confidence limits of 131-226 (Moulin et al. 1993). No measurements of exposure were provided. Based on limited information, however, the production of chromium compounds does not appear to be associated with liver effects. As part of a mortality and morbidity study of workers engaged in the manufacture of chromium(VI) compounds (84%) and chromium(III) compounds (16%) derived from chromium(VI) in Japan, 94 workers who had been exposed for 1-28 years were given a complete series of liver function... 

An ongoing morbidity study among the test subjects is expected to provide a more complete understanding of the long-term consequences of exposure to anticholinergic and anticholinesterase chemicals. 

Workers (mortality stud), 200 (morbidity study), pulp and paper mill Whole body 7.4, trace, and <0.001 in 1958,1962, and 1963 NR 10-yr follow-up mortality and morbidity study. No increased mortality, incidence of specific cause of death, respiratory symptoms, prevalence of chronic nonspecific respiratory disease. Some suggestion that exposure to chlorine or sulfur dioxide might have a slight adverse effect on pulmonary function. Ferris et al. 1979... 

Two studies of workers exposed to low levels of benzene in the workplace showed slight decreases in erythrocyte counts. A morbidity study of 282 workers in a chemical factory reported that 10 persons who were exposed to over 25 ppm of benzene in the workplace for an average of 9 years (range 3-29 years) had an increased mean corpuscular volume at the end of the high exposure period (1963), but normal values 11 years later (1974) (Fishbeck et al. 1978). Further study of these 282 workers revealed slight decreases in erythrocyte counts that were not correlated with levels of benzene exposure (2-35 ppm) or with duration of employment (1 month to over 20 years) (Townsend et al. 1978). 

On the basis of available data, In the judgment of the panel. It Is unlikely that administration of these anticholinergic compounds will have long-term toxicity effects or delayed sequellae. An ongoing morbidity study should provide more definitive Information once It Is completed. 

Lauwerys R, Amery A, Bernard A, Bruaux P, Buchet JP, Claeys F, De Plaen P, Ducoffre G, Fagard R, LIjnen P, Nick L, Roels H, Rondia D, Saint-Remy A, Sartor F, Staessen J. Health effects of environmental exposure to cadmium objectives, design and organization of the Cadmibel study a cross-sectional morbidity study carried out in Belgium from 1985 to 1989. Environ Health Perspect 1990 87 283-289. 

A morbidity study of extruder personnel blending polybutyl-eneterephthalate containing DeBDE during... 

Sakurai H. 1982. A morbidity study of viscose rayon workers exposed to carbon disulfide. BrJIndMed 39 39-44. 

In addition, a morbidity study was recently completed (Ranch Hand study) on pilots who flew spraying missions in Vietnam and on other Air Force personnel. These members of the military were exposed to Agent Orange, a mixture of the herbicides 2,4-D and 2,... 

Herber, R.F.M. (1992). The World Health Organization study on health effects of exposure to cadmium morbidity studies. In Nordberg, G.F., Herber, R.F.M., and Alessio, L. (Eds.) Cadmium in the human environment. Toxicity and carcinogenicity. International Agency for Research on Cancer, Lyon. lARC Scientific Publications No. 118 p. 347-358. 

Morbidity Studies. Morbidity studies are carried out on an active work force and focus on causes of Illness. The sources of data for a morbidity study can be existing records such as health insurance claims or sickness related absence records, if the cause of illness is recorded. 

Morbidity Studies. Morbidity studies have revealed a wide variety of toxic effects in workers exposed to pesticides. 

Mocanu C, Badescu S (1993) A morbidity study of intraocular foreign bodies (in Romanian). Oftalmologia 37 25-32... 

In view of these preliminary results on renal function, it seems logical to hypothesize that the environmental Cd pollution in the Liege area is not only responsible for subclinical signs of intoxication, but may also contribute to an increased mortality by renal diseases. We feel, however, that a more extensive morbidity study combined with an evaluation of the Cd body burden is required before accepting this hypothesis. 

Oberdorster G, Ferin J, Gelein R, Mereer P, Corson N, Godleski J. Low-level ambient air particulate levels and aeute mortality/morbidity studies with ultrafine Teflon partieles. Am J Respir Crit Care Med 1995 15LA66. 

Evidence from mortality and morbidity studies suggest that particulate air pollution affects a sizeable pool of frail and older persons, with underlying chronic... 

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