Category: FDA Drug Safety Oversight
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FDA Mandates NAION Warning on Several Impotence and ED Drugs
Labels on Viagra, Cialis and Levitra are Changed to Address Blindness Issue On July 8, 2005 the FDA ordered warnings be put on the package insert labels of Viagra, Cialis, and Levitra to the…
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Health Canada Advisory Panel Supports Return of Painkiller Vioxx to Market
Canadian Panel Votes Against Bextra Due to Increased Risk of Serious Skin Reactions On July 7, 2005, a panel of medical experts advised Health Canada officials that, in its opinion, the arthritis drug and…
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A Review of the FDA’s Adverse Event Reporting System Database: 1969 to 2002
2.3 million ADE Case Reports Involving Approximately 6000 Prescription Drugs In a recent edition of the Archives of Internal Medicine (Arch Intern Med.2005;165:1363-1369) two researchers from the FDA’s Office of Drug Safety analyzed all…
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FDA Knew of Possible Viagra-Blindness Link as Early as January 2004
Senator Grassley's June 2005 Letter Criticizes FDA's Delay in Alerting Doctors and Patients In January 2004 an FDA safety officer told her FDA supervisors that doctors and patients should be warned of a possible…
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June 2005 BMJ Editorial Calls for Fundamental Changes to Drug Regulation
Current Drug-safety Methods Used by Regulators are Out-dated The July 2, 2005 edition of BMJ, a British medical journal, contains a thoughtful editorial entitled "Drug safety and regulation: New powers and resources are needed".…
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Vioxx Recall Showed Inadequacy of FDA’s Current Drug-safety Monitoring Systems
Expert: Post-marketing Studies Must be Strengthened to Find Meaning of "Signals" Early On On June 29, 2005 Dr. David Wofsy, a rheumatologist associated with the University of California at San Francisco, told an audience…
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Drug Watch: FDA’s New Early-warning System Web Site
Emerging Side-effect Risk Alerts to be Posted by FDA Online In May 2005 the FDA announced the establishment of a new web site, called Drug Watch, which will serve as the FDA’s new online…
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FDA’s Drug Safety Oversight Board Holds First Meeting
No Specific Drug-safety Issues Discussed at Board’s First Meeting On June 17, 2005 the FDA’s Drug Safety Oversight Board (DSOB) held its first meeting, the primary purpose of which was to allow the Board…
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David Graham Speaks at May 2005 Event About Need for Change at FDA
FDA was "the single greatest obstacle" as to Vioxx Withdrawal David Graham says the FDA, itself, was the "single greatest obstacle to doing anything effective" about getting the unsafe prescription drug Vioxx withdrawn from…
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FDA Drug-safety Oversight Efforts Must Improve to Avoid Another Vioxx Debacle
Dr. Garret FitzGerald’s Speech in May 2005 at Edinburgh, Scotland Dr. Garret FitzGerald, a highly regarded medical doctor at the University of Pennsylvania, told a conference in Edinburgh, Scotland that the problems surrounding the…