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• W177565504 abstract "The base of evidence for the relative harm versus benefit for commonly used prescription drugs expanded in 2010, including developments late in 2010 that reinforced the value of pharmacovigilance and the need for critical appraisal of warnings of threat to patient safety. In October 2010, the U.S. Food and Drug Administration (FDA) announced additions to the labels of all biphosphonates warning of the increased risk of atypical fracture of the femur, an outcome that although rare (representing less than 1% of all fractures of the hip and femur) had been “predominantly reported in patients taking bisphosphonates.” These drugs already carried a label warning regarding osteonecrosis of the jaw, and the additional warning precipitated widespread discussion among patients and health care professionals regarding the safety of biphosphonates and the observation that these widely used drugs were associated with adverse events that they were intended to prevent. In September 2010, a 4-year controversy over the relative benefit versus harm of rosiglitazone culminated in withdrawal of the drug from the European market and exceptionally restricted use in the United States including the requirement that patients “acknowledge they understand the [cardiovascular] risks” associated with use of rosiglitazone. The clinical irony for rosiglitazone is that it was used by millions of people with type 2 diabetes to prevent the very adverse cardiovascular events that were found to be associated with its use. It is not yet clear how much of the cardiovascular adverse event profile pioglitazone shares with rosiglitazone, and pioglitazone has a black-box warning regarding the possibility to “cause or exacerbate congestive heart failure.”" @default.
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• W177565504 date "2011-01-01" @default.
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• W177565504 title "Protecting Patients from Adverse Drug Events: Propoxyphene, PIMs, and Drugs to Avoid in Older Adults" @default.
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• W177565504 doi "https://doi.org/10.18553/jmcp.2011.17.1.60" @default.
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