Drugs risk-benefit assessment

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. 

A risk-benefit assessment of a drug can be made looking at the risks of the disease being treated, the chance of improvement by the drug, and the risk from the treatment. A risk-benefit assessment can also be comparative between two or more treatments for the same indication and also examine costs to individuals and the community. It is clear that these assessments should have complete contemporary data for all aspects, and that the data should be organised in such a way as to make qualitative and quantitative comparison easy. 

Edwards IR, Wiholm B-E, Martinez C. Concepts in risk-benefit assessment. Drug Saf 1996 15(1) 1-7. 

Winkler M and Rath W. A risk-benefit assessment of oxytocics in obstetric practice. Drug Safety 1999 20 323-345. 

Seetharam, M.N. and Pellock, J.M. (1991) Risk-benefit assessment of carbamazepine in children. Drug Saf 6 148-158. 

Elgart ML A risk-benefit assessment of agents used in the treatment of scabies. Drug Saf 1996 14 386. [PMID 8828016]... 

Eisenberg DL, Camras CB. A preliminary risk-benefit assessment of latanoprost and unoprostone in open-angle glaucoma and ocular hypertension. Drug Sat 1999 20(6) 505—14. 

Ekman P. A risk-benefit assessment of treatment with finasteride in benign prostatic hyperplasia. Drug Saf 1998 18 161-70. 

Barnes TR, Curson DA (1994) Long-term depot antipsychotics. A risk-benefit assessment. Drug Saf 10(6) 464-479... 

This example shows that (1) the mechanistic PK/PD model developed based on literature data of rHu-EPO and predinical information of a new ERA is suitable to provide a better quantification and prediction of the drug disposition and the time course of hemoglobin in adult healthy subjects, and (2) this model can be used to optimize the design of the Phase I studies of new ERAs, with respect to key design features (number of dose levels, selection of dose levels, number of subjects per dose level, PK/PD sampling times). In this way, a quantitative risk-benefit assessment can be obtained by determining the probability of success of a Phase I study with new ERA, conditional on a certain experimental design. 

For a drug that has never been used in humans previously, the initial step that a pharmaceutical company must take is to perform preclinical toxicity studies involving appropriate in vitro systems or whole animals. The FDA usually requires that dose-related toxicity be determined in at least two mammalian species (routinely rodents). The toxicity information obtained from these studies can then be used to make risk/benefit assessments and help determine the acceptability of the drug for testing in humans, and to estimate a safe starting dose. 

Adams ME, Lussier AJ, Peyron JG (2000) A risk-benefit assessment of injections of hyaluronan and its derivatives in the treatment of osteoarthritis of the knee. Drug Safety 23 115-130... 

If the BNF and SPC do contraindicate or caution against the use of the drug in liver disease, then fnrther investigation and research is generally needed. This is becanse the recommendation may be based on a lack of or inconclusive data, rather than adverse data. In these situations, application of knowledge from first principles is often appropriate, and a risk-benefit assessment for yonr specific patient should be considered. Use of drugs outside their product licence may be considered appropriate in some situations. 

Relevant adverse effects are discussed in Chapter 6. It is important to determine whether the drug you are considering can cause any of these effects, and if so, the severity and the likelihood of those effect(s) occurring. This information will influence the risk-benefit assessment of the use of the medication in your patient. In addition, if you choose to use a drug that has potential associated risks, you will need to know which adverse effects to look out for, to ensure safe treatment. For example, which side effects suggest accumulation, which signs/symptoms/test results suggest hepatotoxicity ... 

Pecknold JC. A risk-benefit assessment of buspirone in the treatment of anxiefy disorders. Drug Saf f 997 f6 f f8-32. 

Mauri MC, Bravin S, Bitetto A, Rudelli R, Invernizzi G. A risk-benefit assessment of sulpiride in fhe freafmenf of schizophrenia. Drug Saff996 f4 (5) 288-98. 

Kleiman NS. A risk-benefit assessment of abciximab in angioplasty. Drug Saf 1999 20(l) 43-57. 

Piscitelli SC, Bhat N, Pan A. A risk-benefit assessment of interleukin-2 as an adjunct to antiviral therapy in HIV infection. Drug Saf 2000 22(1) 19-31. 

Abraham R, Basser RL, Green MD. A risk-benefit assessment of anthracychne antibiotics in antineoplastic therapy. Drug Saf 1996 15(6) 406-29. 

Friedman L, Schron E, Yusuf S. Risk-benefit assessment of antiarrhythmic drugs. An epidemiological perspective. Drug Saf 1991 6(5) 323-31. 

Mazzotta P, Magee LA. A risk-benefit assessment of pharmacological and nonpharmacological treatments for nausea and vomiting of pregnancy. Drugs 2000 59(4) 781-800. 

Beguin Y. A risk-benefit assessment of epoetin in the management of anaemia associated with cancer. Drug Saf 1998 19(4) 269-82. 

Simmons WD, Rayhill SC, Sollinger HW. Preliminary risk-benefit assessment of mycophenolate mofetil in transplant rejection. Drug Saf 1997 17(2) 75-92. 

This book has been organized mainly around bodily systems, since many clinical problems in horses are related to disorders of one or more of these systems. The editors have made an effort to include information on pathophysiology and the dosage, best practice guidelines, precautions and potential adverse effects of the drugs discussed. It is hoped that this information will help the reader in making risk/benefit assessments and in determining the therapeutic objectives for each equine treated. 

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