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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…
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Crestor Side Effects: Reports to FDA MedWatch Analyzed by Tufts Doctors
Crestor-Rhabdomyolysis Link: New Study May Support Allegations by Public Citizen Group Rhabdomyolysis, proteinuria, nephropathy, and kidney or renal failure are serious side effects which apparently occur more often with the use of Crestor (rosuvastatin)…
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SSRI Drugs Can Increase Risk of Gastrointestinal Bleeding
Increased Risk of Acute Gastrointestinal Bleeding When Taking Both SSRIs and NSAIDs Long-term use of selective serotonin re-uptake inhibitors, or SSRIs, increases the risk of gastrointestinal bleeding to a degree similar to that caused…
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FDA Advisory Panel Wants To Review Agency’s Drug-safety Monitoring Efforts
Concern Over FDA’s Handling of Serious Side Effects Issues, Including Recent Drug Recalls Involving Vioxx and Bextra Members of an FDA advisory panel have voted unanimously in favor of having the federal agency provide…
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Natrecor “Dear Doctor” Letter Seeks to Address Recent Safety Concerns
Letter Includes New Natrecor Label Revised in April 2005 Natrecor is a treatment, administered by injection, for patients with acutely decompensated congestive heart failure (ADHF) with dyspnea. Recent reports in medical journals have raised…
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Medication Errors in Hospitals Involve Pharmacy-dispensing Errors in Estimated 10-20% of Incidents
Drug Name Confusion is a Common Cause of Drug-related Errors A medication error is generally defined as a deviation from the prescription drug order written by the prescribing physician on the patient’s chart. In…
