FDA Aims To Improve Drug Safety In Light Of Vioxx Recall
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The US Food and Drug Administration today announced a five-step program to bolster drug safety evaluations. The news comes after controversy over the recall of the arthritis drug Vioxx and risks to children on antidepressants.
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Just as the Enron scandal triggered an overhaul of corporate accounting practices, the nation's prescription drug crisis may prompt a sweeping revamp of the way the Food and Drug Administration ensures drug safety, some say.
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A day after the popular arthritis drug Vioxx was yanked from the market because of safety concerns, doctors, patients and insurance companies were busy trying to figure out the next step.
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The U.S. Food and Drug Administration on Friday asked an outside group to review the way the agency monitors safety risks of medicines after they hit the market, such as Merck & Co. Inc.'s withdrawn painkiller Vioxx.
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NEW YORK - The recall of Vioxx and the news that Celebrex likewise doubled or tripled the risk of heart attack in a long-term study were bad enough.
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The U.S. Food and Drug Administration said on Tuesday it would make organizational changes to improve internal communication about potential risks that emerge after a new drug reaches the market.
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Prescription-drug recalls aren&#39;t common, and they&#39;re almost always controversial. Now that Merck (MRK ) is voluntarily withdrawing its Vioxx pain medication around the world, due to a heightened risk of cardiovascular
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Drug giant Merck says the Food and Drug Administration wants more information, but is prepared to approve the company&#39;s successor drug to recalled pain reliever Vioxx.
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Merck&#39;s recall of its arthritis pain drug, Vioxx, because of elevated risks of heart attack and stroke has obscured another important issue that Congress, in investigating the matter, must face squarely and deal with: What happens when pharmaceutical
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WASHINGTON -- A Food and Drug Administration official is defending the agency&#39;s action with regards to Vioxx. The drug was taken off the market Sept.
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The Food and Drug Administration is responding to the widespread criticism of the government's handling of drug safety problems.
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The US 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 &amp; Co.
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WASHINGTON -- A veteran Food and Drug Administration safety officer yesterday told a Senate hearing inquiring into the abrupt recall of the arthritis drug Vioxx that five other widely used drugs should be either withdrawn or sharply restricted because they have dangerous side effects.
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The recent Vioxx withdrawal and  testimony from an FDA insider accusing the agency of failing to  protect public health are fueling such heightened concern over  drug safety that valuable medicines could be kept from  patients, doctors said on Friday.
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WASHINGTON -- After months of heightened concerns about the safety and effectiveness of Vioxx and similar best-selling painkillers, and intense criticism of how the Food and Drug Administration has handled them, the agency will launch critical meetings beginning tomorrow on what to do next.
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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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The recall of Merck&#39;s arthritis drug Vioxx has drawn attention to drug overall safety, more specifically, a similar drug known as Celebrex, by the drug maker Pfizer.