Doctors Ponder FDA Drug Controversy
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Startling testimony by an FDA drug safety reviewer about five popular medications has the medical world buzzing about how tightly the agency should be regulating new medications.
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ROCKVILLE, Md.  - The U.S. Food and Drug  Administration on Friday asked an outside group to review the  way it monitors safety risks associated with medicines already  on the market, such as Merck & Co. Inc.'s withdrawn painkiller  Vioxx.
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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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Doctors are struggling to decide which pain relievers to prescribe now that they know that drugs like Vioxx and Celebrex pose serious heart risks.
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Washington, Dec 16 : One-fifth of the US Food and Drug Administration (FDA) scientists surveyed as part of an official review have said they had been pressured to recommend approval of a new drug despite their reservations about its safety, effectiveness
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Following results of recent clinical trials on popular cholesterol drugs, cardiologists are questioning whether a patientâs cholesterol should be all that matters.
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Congress has been investigating the FDA&#39;s decisions in both the Vioxx and antidepressant cases. The probes have focused on agency reviewers who warned about potential problems but claimed their research was ignored or suppressed by other officials.
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Across the country, doctors are struggling to decide which pain relievers to prescribe now that they know that popular drugs like Vioxx and Celebrex pose potentially serious heart risks.
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SOME of Britainâs most popular medicines are to be reviewed by drug regulators after claims by an American scientist that they pose severe risks to patients and should not be prescribed.
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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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The problems with Vioxx, taken off the market last week, raise questions about the Food and Drug Administration's safety review process. Observers say longer clinical trials should be required.
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Federal regulators Thursday urged doctors to think twice before prescribing several popular and controversial painkillers to their patients with histories of heart trouble.
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U.S. health officials said on Friday  they would review whether to take regulatory action over Merck  & Co Inc  and Schering-Plough's  cholesterol  medicine Vytorin following the drug's failure to work better  than a generic drug in a study of plaque build-up in neck  arteries.
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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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With yet more already-marketed medicines raising the ire of consumer advocates and regulators alike, momentum is building for reform of the governmentâs drug approval and monitoring procedures.
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It&#39;s not been a good year for the Food and Drug Administration â-ith a controversy over the use of antidepressants by children and adolescents, the withdrawal
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BusinessWeek Online - The news last week that GlaxoSmithKline&#39;s  popular diabetes drug Avandia may increase the risk of heart attacks is now causing a rift among doctors by specialty, leading to charges by each side that the other is endangering patients. Endocrinologists, who treat diabetics, tend to regard the data, which was published in The New England Journal of Medicine, with skepticism, pointing to weaknesses in the study, particularly when compared to more rigorous clinical trials. Cardiologists and drug safety experts, foremost among them study author Dr. ...