Risk-benefit profile

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

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. 

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... 

Today s pharmaceuticals are not the routine antibiotics of yesteryear. FDA is now approving more sophisticated and complicated chemical entities with complex risk/benefit profiles. Some products currently on the market, such as Accutane (isotretinoin, Hoffmann-LaRoche, Nutley NJ, U.S.A.), might not be there without patient information accompanying the product. Patients must understand the risks and limitations of medical products so they can use them properly. By necessity, patient education will become more critical as regulatory agencies approve more drugs with complicated regimens and interaction profiles. 

There is limited evidence on the effectiveness of most drugs at the time they are introduced. For example, many drugs are granted marketing authorization based on surrogate endpoints, such as reduction in lipid levels, as the actual effects on health may take a very long time to be measured. The rewards authority would therefore have to make its best estimate as to the risk-benefit profile of the product, and would presumably update the reward level as new information became available. 

Lader, M. Benzodiazepines a risk-benefit profile. CNS Drugs 1994 1 377-87. 

The adverse event needs to be clinically significant enough that the risk-benefit of therapy is percieved to be altered. In this regard, the acceptable risk-benefit profile of anti-cancer therapies is markedly diflFerent than, for example, that of anti-hypertension therapy. 

Ernst E. The risk-benefit profile of commonly used herbal therapies Ginkgo, St. John s wort, ginseng, echinacea, saw palmetto, and kava. Ann Intern Med. 2002 136 42-53. 

New small molecule FXa inhibitors currently in development are able to enter the clot/prothrombinase complex and inhibit free and bound factor Xa regarded as the key enzyme in ACS. Although direct FXa inhibitors do not inhibit platelet aggregation, they abolish platelet-dependent thrombus formation in canine coronary thrombosis. Thus, direct inhibition of FXa may have higher efficacy and better risk/benefit profile than existing antithrombotic therapies in the treatment and prevention of ACS. 

In practice, the regulatory framework governing the first dose of a biopharmaceutical in humans is designed around several fundamental tenets know the safety profile for the test agent, maintain a positive risk-benefit profile in each subject population, and beware of the unknown. 

Ibuprofen is an effective analgesic and antipyretic and has a favourable risk-benefit profile. 

The expected adverse event profile will also determine the study design. A drug for which the prescription is to be initiated in a tertiary referral clinic by leading experts in the field, such as many oncological compounds, will have a different safety profile compared with a product which will be widely used across many different specialties in primary and secondary care. Characterisation of the risk-benefit profile is an important consideration in study design. 

TABLE 27.1 Risk-Benefit Profile of FDCs and Multiple Ligands ... 

Indeed, larger-scale, double-blind, place-bo-controUed chnical trials with Ad5FGF-4 (AGENT 3 and AGENT 4) are currently under way at centers throughout the world. These trials will characterize further the risk-benefit profile of the product, the optimal dose that should be administered, and the patient population likely to derive greatest benefit from this promising new biopharmaceutical therapy. 

Scheen AJ (2010). Cardiovascular risk-benefit profile of sibutra-mine. Am J Cardiovasc Drugs 10(5) 321-334. 

In another one-year, double-blind, randomised study to evaluate the endometrial safety and bleeding pattern, a low-dose combination of 0.25 mg DRSP/0.5mg 17p-oestradiol demonstrated a favourable risk/benefit profile in postmenopausal women [53 ]. 

C. J. Clements and P. B. McIntyre, When science is not enough - a risk/ benefit profile of thiomersal-containing vaccines. Expert Opin. Drug Saf., 2006, 5, 17-29. 

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