Risk-benefit assessments

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. 

Pharmacologically Predictable Adverse Events or Nonresponse Obtained in Early-Phase Development Affect the Risk/Benefit Assessment and Product Labeling . 213... 

The risk-benefit assessments depend on whether the research involves the use of interventions that have the intent and reasonable possibility of providing a benefit to the participant, or whether it only involves procedures for research purposes. In research containing interventions expected to provide direct benefit to the participants, a certain amoxmt of risk is justifiable. In research where no direct benefits are anticipated, the IRB should evaluate whether the risks presented by procedures only to obtain generalized knowledge are ethically acceptable. ... 

Heavy menstrual blood loss evaluation Prior to prescribing meclofenamate for heavy blood flow and primary dysmenorrhea, make a thorough risk/benefit assessment. 

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. 

Consideration of the implications of teratogenicity in animals leads to the (somewhat vexed) question of maternal toxicity. Since the publication of papers by Khera for example (9), there has been a view expressed in some snbmission documents that if effects on reprodne-tion occur in the presence of maternal toxicity, then these effects can almost be discounted or certainly their significance is minimized. While this might apply in some cases, it certainly does not apply universally and can lead to misleading risk-benefit assessments. 

The risk-benefit assessment is of paramount importance in clinical trial applications, largely because of the uncertainty of the potential benefits. The points covered in the Subheading 4.1 and the Subheading 4.2 analysis should be borne in mind for this section of the IB. 

In most cases, safety monitoring wUt be the major task for a DMC. Even if the safety parameters monitored are not directly related to efficacy, a DMC might need access to unblinded efficacy information to perform a risk/benefit assessment in order to weigh possible safety disadvantages against a possible gain in efficacy. ... 

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]... 

Mos, L., Jack, J., Cullon, D., Montour, L., Alleyne, C., and Ross, P. S. (2004). The importance of marine foods to a near-urban first nation community in coastal British Columbia, Canada Toward a risk-benefit assessment. J. Toxicol. Environ. Health A 67, 791-808. 

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. 

Experts speak of perceived risk versus perceived benefit when attempting to understand the teenage trends of marijuana use. Most of our everyday decisions are based on a balanced scale of these two ideas. When deciding to do something, we weigh the pros and cons—the benefits and risks—and then make our decision. It is commonly believed that this risk/ benefit assessment is a primary factor in determining whether or not a teen will use marijuana. 

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 ... 

Many centres prefer to avoid using NSAIDs in any patient with liver disease because of their side-effect profile. However, if the liver disorder is purely cholestatic in origin and the disease has not progressed to cirrhosis and portal hypertension, NSAIDs may be an option. Any risk-benefit assessment should consider the potential risk of hepatotox-icity, albeit rare. There are no specific contraindications in this patient because they are not cirrhotic, do not have deranged clotting, and are unlikely to be at increased risk of deteriorating renal function. If deemed necessary an NSAID could be used cautiously. 

BETA-BLOCKERS X-RAY CONTRAST SOLUTIONS Beta-blockers are associated with T risk of anaphylactoid reactions to iodinated X-ray contrast materials Uncertain, but postulated that beta-receptors have a role in suppressing the release of mediators of anaphylaxis Consider using low-osmolality contrast media and pretreating with antihistamines and corticosteroids. Stopping beta-blockers a few days before the X-ray is associated with a risk of withdrawal t BP and tachycardia a risk-benefit assessment must therefore be made... 

INTRAVENOUS-KETAMINE THEOPHYLLINE Risk of fits Uncertain A careful risk-benefit assessment should be made before using ketamine. However, there are significant benefits for the use of ketamine to anaesthetize patients for emergency management of life-threatening asthma... 

European Commission, Directorate C Scientific Opinions, Preliminary report on scientific quality of life criteria in risk benefit assessment, meeting 16 May 2002. 

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