Risk Versus Benefits

Blockers may be used by those with reactive airway disease or peripheral vascular disease, but should be used with considerable caution or avoided if patients display active respiratory symptoms. Care must also be used in interpreting shortness of breath in these patients, as the etiology could be either cardiac or pulmonary. A selective (3 r -blocker such as metoprolol is a reasonable option for patients with reactive airway disease. The risk versus benefit of using any (3-blocker in peripheral vascular disease must be weighed based on the severity of the peripheral disease. 

Psychiatric adverse effects occur frequently and may include irritability, depression, and rarely, suicidal ideation. Individuals with a history of uncontrolled psychiatric disorders must weigh the risk versus benefit of treatment, as interferon may exacerbate or worsen the psychiatric condition. Patients who develop mild to moderate symptoms may require antidepressants or anxiolytics. Those with severe symptoms including suicidal ideation should have the treatment discontinued immediately.43... 

What would you tell HT regarding the significance of her symptoms, elevated TSH level, and risk versus benefits of LT4 therapy ... 

Ari pi prazole, olanzapine, quetiapine, risperidone, and ziprasidone are effective as monotherapy or as add-on therapy to lithium or valproate for acute mania. Prophylactic use of antipsychotics can be needed for some patients with recurrent mania or mixed states, but the risks versus benefits must be weighed in view of long-term side effects (e.g., obesity, type 2 diabetes, hyperlipidemia, hyperprolactinemia, cardiac disease, and tardive dyskinesia). 

The regulatory process is the filing of an IND for clinical trials. At the conclusion of clinical trials, the Sponsor files a Biological License Application (BLA) for marketing approval. The CBER evaluates a biologic in terms of risk versus benefits before approving it for marketing. 

TSCA is a balancing-type law. It is concerned with unreasonable risks. It attempts to balance risks versus benefits for all chemicals and uses. The EPA administrator must consider (1) effects on health, (2) effects on the environment, (3) benefits and availability of substitutes, and (4) economic consequences. 

The rational use of any medication requires a risk versus benefit assessment. Among the myriad of risk factors that complicate this assessment, pregnancy is one of the most perplexing. 

The discussion on the balance of the risks versus benefits should spell out explicitly any reasoning and scientific principles used in arriving at the final judgement. 

What are the risks versus benefits for continued use of the agent ... 

The requirements for the format and content of the IND application, as well as the requirements governing the use of the IND, are provided in Title 21 of the Code of Federal Regulations (21 CFR), Section 312. Unlike an NDA, the FDA does not formally approve an IND submission. If the FDA reviewers believe that the proposed clinical trial(s) submitted in the IND are acceptable from a safety and risk versus benefit viewpoint, the IND is in effect, and the compound that is the subject of that IND may be shipped in interstate commerce for the purpose of conducting specific clinical trials. Drugs shipped under an IND have specific labeling requirements, and false or misleading statements, as well as any claims regarding safety and efficacy, are prohibited. 

Some individuals may respond better to 3,200 mg as opposed to 2,400 mg, although well-controlled trials show no better response consider risk versus benefits when using 3,200 mg/day. 

Thus the NNT is 46. That is, treating 46 patients with unstable angina for 9 months with aspirin with clopidogrel should prevent Ml, stroke, or CV death in 1 patient. To balance risks versus benefits of an intervention, we can generate a similar number needed to harm to express the risks associated to the intervention. 

All medications used in the treatment of bipolar disorder are secreted in breast milk, thus the risks versus benefits must be weighed. 

The decision of which regimen to use depends on the perceived risk versus benefit. For example, a 2-week course of gentamicin in an elderly patient with renal impairment may be associated with ototoxicity, worsening renal function, or both. Furthermore, the 2-week regimen is not recommended for patients with complications such as extracardiac foci. On the other hand, a 4-week course of penicillin alone generally entails greater expense, especially if the patient remains in the hospital. Monotherapy with once-daily ceftriaxone offers ease of administration, facilitates home health care treatment, and may be cost-effective. ... 

Eligibility Documents (REDs), which provide discussions of risks versus benefits. Cancer risks greater than 10 are generally deemed worthy of mitigation, which might include reformulation, use restrictions, cancellation, or voluntary withdrawal of the product by the manufacturer. 

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