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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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Vioxx Trial Scheduled for July 11 in Texas Given Green Light
Texas Judge Denies Merck’s Request to Delay First Vioxx Case On July 5, 2005 a Texas judge declined a request by lawyers for Merck & Co. to postpone the nation’s first Vioxx trial, which…
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Ritalin-Cancer Link: Researchers Emphasize Their Finding was Preliminary, Only
The FDA is Investigating the Possibility of a Ritalin-Cancer Association In late June 2005 it was widely reported that the FDA was examining a potential link between Ritalin and cancer. What did not get…
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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…
