Risk/benefit

It must be remembered that all anesthetics and tranquilizers are used by the practitioner following a risk—benefit evaluation. General anesthesia, even being adininistered by an experienced practitioner, can result in death through cardiac or respiratory depression. The veterinarian is acutely aware of these risks and chooses the dmg and method of adininistration considering the patient s health status, the nature of and need for the procedure, and the likelihood of success. 

In the veterinary as in the human patient, neoplasms are often metastatic and widely disseminated throughout the body. Surgery and irradiation are limited in use to weU-defined neoplastic areas and, therefore, chemotherapy is becoming more prevalent in the management of the veterinary cancer victim (see Chemotherapeutics, anticancer). Because of the expense and time involved, such management must be restricted to individual animals for which a favorable risk—benefit evaluation can be made and treatment seems appropriate to the practitioner and the owner. In general, treatment must be viewed not as curative, but as palliative. 

Fig. 1.4.4-1 Revealed and risk-benefit relationships (from Starr, 1971). Reprinted with permission from Perspectives on Benefit-Risk. Decision Malang, National Academy of Engineering, U.S.A.

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. ... 

Providing the Competent Authorities with other information relevant to maintaining an up-to-date picture of the risk benefit profile of the product. 

To translate this approach into clinical scenarios, the risk-benefit assessment of chemotherapy administration in already immunocompromised patients would favor situations in which cytotoxic drugs are indicated anyhow, such as in AIDS-related lymphomas, where alkylating agents are part of the standard regimens. 

The pharmacoeconomics of the anxiety disorders has received litde attention. In the past drug costs were largely incurred by use of benzodiazepines, most of which are available in generic forms and are cheap. They are effective and acceptable in the short term. Long-term use is associated with the risk of physical dependence, with an adverse risk—benefit ratio and high cost terms to facilitate withdrawal. There is now a trend towards the use of antidepressants in the anxiety disorders. Clinical experience has been followed by formal trial evaluation. 

Clinical trials and meta-analyses have demonstrated that early carotid endarterectomy (CEA) is the preferred treatment for most patients with severe symptomatic internal carotid artery (ICA) stenosis and selected patients with moderate disease.However, CEA is often delayed in chnical practice, or may not be appropriate in some patients due to an unfavorable risk-benefit profile. In these settings, it is reasonable to consider acute antithrombotic treatment to prevent early recurrent stroke. 

SHEEHAN D M (1998) Herbal medicines, phytoestrogens and toxicity risk benefit considerations. Proc Soc Exp Biol Med. 217 (3) 379-85. 

The safety of a diet could be defined as the overall risk-benefit of consuming that diet over a lifetime. This concept is not one that is applied in determining the safety of a chemical in food. Safety is almost invariably considered as the absence, or minimisation, of risk and not as the maximisation of benefit. Consequently, the scientific basis for regulating food chemicals is based on principles that were developed for assessing the risks posed by pharmaceuticals and industrial chemicals, and minimising these, rather than for maximising the benefits. 

Long-term use of oral corticosteroids should be avoided due to an unfavorable risk/benefit ratio. The steroid myopathy that can result from long-term use of oral corticosteroids weakens muscles, further decreasing the respiratory drive in patients with advanced disease. 

Acetaminophen is a centrally acting analgesic that produces analgesia by inhibiting prostaglandin production in the brain and spinal cord. It is an effective and inexpensive analgesic with a favorable risk-benefit profile.9 It should be tried initially at an adequate dose and duration before considering an... 

There is concern regarding administration of dexamethasone to patients with pneumococcal meningitis caused by penicillin- or cephalosporin-resistant strains, for which vancomycin would be required. Animal models indicate that concurrent steroid use reduces vancomycin penetration into the CSF by 42% to 77% and delays CSF sterilization due to reduction in the inflammatory response.23 Treatment failures have been reported in adults with resistant pneumococcal meningitis who were treated with dexamethasone, but the risk-benefit of using dexamethasone in these patients cannot be defined at this time. Animal models indicate a benefit of adding rifampin in patients with resistant pneumococcal meningitis whenever dexamethasone is used.21,23... 

BSE Age greater than or equal to 20 risk/benefit discussion All ages NR... 

The protective efficacy of Engerix B has been demonstrated in a number of trials, in the context of infants, children and adults. Seroprotection rates (measured as serum anti-hepatitis B antibody titres above a value of 10 mlU ml-1) of over 95 per cent were usually recorded. The product was found to be generally well tolerated. The most frequently reported adverse effects were local reactions at the injection sites, fever, headache and dizziness. Special consideration to risk benefit ratio should be given to MS patients, as exacerbations of this condition have been (rarely) reported following administration of hepatitis B and other vaccines. Engerix B is manufactured and marketed by GlaxoSmithKline. 

Clinical evidence indicates that the use of tamoxifen increases survival up to 10 years in women with breast cancer. Tamoxifen also seems to diminish the incidence of breast cancer in healthy women with a high risk of suffering from the tumor. Its use as a therapy in breast cancer should be accompanied by careful periodic vigilance of the endometrium. In healthy women, a careful evaluation of the risk/benefit for each and every woman should be imposed. 

Hormone therapy has proven highly effective in controlling the menopausal syndrome, especially severe hot flushes (MacLennan et al. 2004), even at doses significantly lower than those used until now (Speroff et al. 2000 Utian et al. 2001). Women s Health Initiative studies found that hormone replacement therapy, when administered as a primary prevention intervention for CVD in older women, increases the risk of heart disease and breast cancer. Even if a protective effect on fracture and colon cancer was observed, the risk-benefit ratio led to a recommendation of this treatment only for the short-term relief of menopausal symptoms (Rossouw et al. 2002 Anderson et al. 2004). The role of early administration of ovarian hormones to young postmenopausal women in the prevention of cardiovascular disease or late dementia remains... 

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