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- W2415301908 abstract "The drug safety system in the United States has come under fire once again, this time due to problems with Food and Drug Administration (FDA)–approved medications that have been on the market for several years. Adverse drug reactions (ADRs) and unanticipated health problems have occurred with the arthritis medications rofecoxib (Vioxx) and celecoxib (Celebrex), the diabetes medication rosiglitazone maleate (Avandia), selective serotonin reuptake inhibitors used to treat adolescents with depression, and dexfenfluramine (Redux) when used in combination with phentermine for weight loss.1 Vioxx, for example, was on the market for more than five years before Merck officials decided to withdraw the drug due to liability and safety concerns. To date, 88,000 people have developed cardiovascular problems while taking Vioxx, and 13,000 lawsuits have been filed against the manufacturer.2In response to these and other concerns, numerous Congressional hearings have been held on drug safety. One result of these hearings is the FDA Revitalization Act of 2007. This new law includes such measures designed to promote drug safety as mandatory registration of clinical trials of products submitted to the FDA for approval, and restructuring and strengthening of the FDA.3Critics have identified various problems with the U.S. drug safety system, including underfunding of the FDA, financial conflicts of interest on FDA advisory panels and in clinical research, lack of transparency and openness in industry-sponsored research, and an insufficient number of test subjects in premarketing studies.4,5 Most critics also agree that the U.S. postmarketing safety assessment system is woefully inadequate and out of date.6,7 According to one critic, postmarketing safety assessment “is essentially a system developed in the 1950s … the system cannot be used to test hypotheses but simply to generate them.”8 This state of affairs stands in sharp contrast to the scientifically rigorous and innovative premarketing research system used in the U.S., which synthesizes and analyzes data from animal studies and three phases of controlled clinical trials on human subjects." @default.
- W2415301908 created "2016-06-24" @default.
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- W2415301908 date "2008-04-01" @default.
- W2415301908 modified "2023-09-23" @default.
- W2415301908 title "Postmarketing Research and Surveillance: Issues and Challenges." @default.
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