Human risk reaction

The evaluation of human risk reaction towards technology raises the question of defensible risks which can be accepted in the course of utilization. For some time this has been the subject of intensive discussion on the part of those active in the humanities, theology, and the engineering sciences, Defensible is intended to mean that developments, conditions, and decisions can be justified by those responsible vis a vis society in such a way that refutation of criticism and predominant agreement can be expected. 

The primary concern with the use of spironolactone is the development of hyperkalemia, which can be fatal. Spironolactone may cause hypersensitivity reactions, gastrointestinal disturbances, peptic ulcer, gynecomastia, decreased libido, and impotence. It also has been implicated in tumor production during chronic toxicity studies in rats, but human risk has not been documented. 

Thermal sensation is the human thermal perception which according to thermal environment surround, triggers a human body reaction (Parsons, 2003). The skin temperature is considered by some authors (Kataoka et al., 1998 Zingano, 2001) as a reference temperature to evaluate human thermal sensation. A thermal comfort sensation is defined as a neutral sensation or the state of satisfaction of an individual when exposed to a thermal environment (ASHRAE, 2001 Chow, Fong, Givoni, Lin, Chan, 2010). On the other hand a stress thermal sensation is the state of dissatisfaction of an individual when exposed to a thermal environment (Meles, 2012 Talaia, Meles, Teixeira, 2013) When an individual are under extreme thermal environments, either hot or cold, the risk of failures and work accidents increase (Riniolo Schmidt, 2006). Furthermore, many studies demonstrate a strong relation between comfort and productivity (Bluyssen, Aries, van Dommelen, 2011). 

In vitro studies in human liver fractions indicated that azacitidine may be metabolized by the liver. Azacitidine and its metabolites are known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. 

The overall objective of clinical trials is to establish a drug therapy that is safe and effective in humans, to the extent that the risk-benefit relationship is acceptable. The ICH process has developed an internationally accepted definition of a clinical trial as Any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of one or more investigational medicinal product(s), and/or to identify any adverse reactions to one or more investigational medicinal product(s) and/or to study absorption, distribution, metabolism and excretion of one or more investigational medicinal product(s) with the object of ascertaining its (their) safety and/or efficacy. ... 

Adding another layer of complexity to the regulation of mast cell activation levels in vivo is the observation that activated mast cells can respond to, and in some cases produce, a myriad of mediators that may serve to amplify FceRI-induced responses. For example, stem cell factor (SCF), the ligand for KIT, both can enhance FceRI-dependent activation of mouse or human mast cells and, under certain circumstances, can directly induce mast cell degranulation [6, 25, 62]. Thus, elevated SCF levels and/or activating KIT mutations (such as those that occur in mastocytosis) may exacerbate mast cell-driven reactions. Indeed, patients (both adult and children) with extensive skin disease associated with mastocytosis are at increased risk to develop severe anaphylaxis [63]. Moreover, it was recently reported that cases of idiopathic anaphylaxis are... 

Generally, the major adverse effects associated with colloids are fluid overload, dilutional coagulopathy, and anaphy-lactoid/anaphylactic reactions.24,32 Although derived from pooled human plasma, there is no risk of disease transmission from commercially available albumin or PPF products since they are heated and sterilized by ultrafiltration prior to distribution.24 Because of direct effects on the coagulation system with the hydroxyethyl starch and dextran products, they should be used cautiously in hemorrhagic shock patients. This is another reason why crystalloids maybe preferred in hemorrhagic shock. Furthermore, hetastarch can result in an increase in amylase not associated with pancreatitis. As such, the adverse-effect profiles of the various fluid types should also be considered when selecting a resuscitation fluid. 

Document any risk factors for allergic reactions such as chronic urticaria, liver or kidney disease, human immunodeficiency virus, or any other immune deficiencies. 

All monoclonal antibodies end in the suffix -mab. The syllable before -mab indicates the source of the monoclonal antibody (see Table 85-4). When administering an antibody for the first time, one should consider the source. The less humanized an antibody, the greater is the chance for the patient to have an allergic-type reaction to the antibody. The more humanized the antibody, the lower is the risk of a reaction. The severity of the reactions may range from fever and chills to life-threatening allergic reactions (which have resulted in death). Premedication with acetaminophen and diphenhydramine is common before the first dose of any antibody. If a severe reaction occurs, the infusion should be stopped and the patient treated with antihistamines, corticosteroids, or other supportive measures. 

Estimates of exposure levels posing minimal risk to humans (MRLs) have been made, where data were believed reliable, for the most sensitive noncancer end point for each exposure duration. MRLs include adjustments to reflect human variability and, where appropriate, the uncertainty of extrapolating from laboratory animal data to humans. Although methods have been established to derive these levels (Barnes et al. 1987 EPA 1989a), uncertainties are associated with the techniques. Furthermore, ATSDR acknowledges additional uncertainties inherent in the application of these procedures to derive less than lifetime MRLs. As an example, acute inhalation MRLs may not be protective for health effects that are delayed in development or are acquired following repeated acute insults, such as hypersensitivity reactions, asthma, or chronic bronchitis. As these kinds of health effects data become available and methods to assess levels of significant human exposure improve, these MRLs will be revised. 

Although specific antisera have proven invaluable in the treatment of a variety of medical conditions (Table 13.1), they can also induce unwanted side effects. Particularly noteworthy is their ability to induce hypersensitivity reactions some such sensitivity reactions (e.g. serum sickness ) are often not acute, whereas others (e.g. anaphylaxis) can be life threatening. Because of such risks, antibody preparations derived from human donors (i.e. immunoglobulins) are usually preferred as passive immunizing agents. 

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