Benefits and Risks of Drug Treatments
- 26 November 2008
- journal article
- editorial
- Published by American Medical Association (AMA) in JAMA
- Vol. 300 (20), 2417-2419
- https://doi.org/10.1001/jama.2008.723
Abstract
The central theme of the Institute of Medicine report on the US drug safety system was the need for a life cycle approach to drug evaluation: both the benefits and the risks need to be evaluated and integrated during the entire market life of a drug.1 The Food and Drug Administration Amendments Act of 2007 also called on the agency to improve its methods of communicating risks and benefits to patients and physicians. The Institute of Medicine recommendation to “develop and continually improve a systematic approach to risk-benefit analysis for use throughout the [Food and Drug Administration] in the preapproval and postapproval settings” specifically acknowledges the need for and the challenges of the development of new methods of combining evidence about risks and benefits.1This publication has 10 references indexed in Scilit:
- Reporting of adverse events in systematic reviews can be improved: survey resultsJournal of Clinical Epidemiology, 2008
- Meta‐analysis: gastrointestinal bleeding due to interaction between selective serotonin uptake inhibitors and non‐steroidal anti‐inflammatory drugsAlimentary Pharmacology & Therapeutics, 2007
- Increasing Levels of Restriction in Pharmacoepidemiologic Database Studies of Elderly and Comparison With Randomized Trial ResultsMedical Care, 2007
- What is the best evidence for determining harms of medical treatment?CMAJ : Canadian Medical Association Journal, 2006
- Comparison of evidence on harms of medical interventions in randomized and nonrandomized studiesCMAJ : Canadian Medical Association Journal, 2006
- Challenges in Systematic Reviews That Assess Treatment HarmsAnnals of Internal Medicine, 2005
- When are observational studies as credible as randomised trials?The Lancet, 2004
- A comparison of three different sources of data in assessing the frequencies of adverse reactions to amiodaroneBritish Journal of Clinical Pharmacology, 2004
- Assessment and Control for Confounding by Indication in Observational StudiesJournal of the American Geriatrics Society, 1999
- CASE-CONTROL STUDIES IN THE EVALUATION OF DRUG-INDUCED ILLNESSAmerican Journal of Epidemiology, 1978