Many FDA scientists had drug concerns
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Almost one-fifth of the Food and Drug Administration scientists surveyed two years ago as part of an official review said they had been pressured to recommend approval of a new
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The latest studies on Avandia, GlaxoSmithKline's blockbuster diabetes drug, have raised enough questions about the drug's safety to worry the American Diabetes Association.
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Heart problems that pushed the painkillers Bextra and Vioxx off the market could have come to light earlier had federal regulators given outside researchers speedier access to raw safety data, according to a commentary written by Boston researchers.
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By , New York Times. Dozens of former and current Food and Drug Administration officials, outside scientists and advocates for patients say that the agency&#39;s efforts to monitor the ill-effects of drugs that
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With Vioxx off the market because of links to heart problems and concerns growing about the related drugs Celebrex and Bextra, a pair of Food and Drug Administration advisory committees are assessing the safety of the popular painkillers.
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Description: A scientist singles out five drugs as unsafe while testifying before a Senate committee on the Food and Drug Administration&#39;s oversight of Vioxx.
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Scientists and European regulators are now questioning the safety of other pain relievers like Vioxx, saying they also might raise the risk of heart attack and stroke.
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Doctors have been taking calls from anxious patients ever since a Senate hearing on Vioxx last week at which an FDA scientist expressed concerns about the safety of five other drugs on the market.
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A day after troubling reports about the popular pain relief drug Celebrex, more questions are being asked about the approval process for such drugs.
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Federal advisers who met last week to consider whether to restrict doses of popular antianemia drugs were themselves under scrutiny during the hearing. The Food and Drug Administration is considering a top-to-bottom reshaping of how it picks and uses the outside scientists who serve on the agency's advisory panels.
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Americans are exposed to dangerous medicines because drug makers do not adequately disclose side effects and regulators are failing to react fast enough to safety risks, according to a prominent medical journal.
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BOSTON - The safety of Celebrex and other pain relievers was questioned Wednesday as scientists in the United States and regulatory agencies in Europe said they feared such drugs might raise the same risk of heart problems as those blamed on the arthritis
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Many doctors who were sanctioned by a medical board were later paid for research by drug makers.
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U.S. drug safety regulators are coming under fire for their response to years of suspicions, confirmed last week, that arthritis drug Vioxx increased the risks of heart attacks and strokes.
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Nearly 20 percent of US Food and Drug Administration scientists surveyed in late 2002 said they were pressured to approve or recommend approval of a medicine despite
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Two-thirds of Food and Drug Administration scientists surveyed two years ago lacked confidence that the FDA adequately monitors the safety of prescription drugs, a report released Thursday shows.
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U.S. lawmakers criticized the Food and Drug Administration's monitoring of the risks of a Sanofi-Aventis antibiotic and some other prescription drugs on Tuesday.