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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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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…
