FDA Orders Review of Painkiller Data, Issues Cox-2 Advisory
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The furor over the safety of arthritis painkilling medications shows no sign of abating. Vioxx is gone from the market, following data linking it to increased cardiovascular risk.
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Officials from Pfizer Inc, Merck & Co Inc and Novartis AG will appear next week before a panel of European drug experts, who are meeting to consider curbs on the use of COX-2 painkillers.
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U.S. health regulators warned on Monday of heart risks connected to over-the-counter painkiller naproxen, creating additional confusion over the safety of similar drugs after recent warnings for two other painkillers.
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Patients taking a class of painkilling drugs called Cox-2 inhibitors have been advised to contact their GP to review their treatment.
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Drugs in the same category as Merck &amp; Co. Inc.&#39;s withdrawn Vioxx painkiller will get close scrutiny to see if they can also cause heart attacks, US Food and Drug Administration officials said on Thursday.
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The story of COX-2 drugs is an example of how difficult it is for the F.D.A. to monitor the safety of drugs after they have been approved for the market.
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The US Food and Drug Administration says it plans to convene a panel of experts in February to discuss the safety of painkillers in the same class as the now-withdrawn drug Vioxx.
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The U.S. Food and Drug Administration on Thursday ordered the review of preventative studies involving Pfizer Inc.'s painkillers Celebrex and Bextra, in light of recent evidence they may increase the risk of heart attack and stroke.
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The U.S. Food and Drug  Administration on Thursday ordered the review of preventative  studies involving Pfizer Inc.'s painkillers Celebrex and  Bextra, in light of recent evidence they may increase the risk  of heart attack and stroke.
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FRIDAY, Nov. 17 (HealthDay News) -- Just-released data from a trial that was stopped early in 2004 for safety reasons is re-igniting debate on the safety of two popular painkillers.
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The Food and Drug Administration has told a researcher that he cannot be part of an advisory panel that will meet early next year to review the safety of a class of drugs, COX-2 inhibitors, used to treat arthritis and pain.
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The Food and Drug Administration told Merck &amp; Co. that the company needs to supply more data for its Arcoxia pain treatment to gain approval, the pharmaceutical company said Friday.
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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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Two years after the withdrawal of the painkiller Vioxx, a dysfunctional Food and Drug Administration still can't adequately track the safety of new drugs and respond quickly to problems, a panel of experts said Friday.
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U.S. health regulators recommended  on Thursday that doctors limit prescribing painkillers like  Pfizer Inc.'s Celebrex and Bextra, in light of recent evidence  that they may increase the risk of heart attack and stroke.
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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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U.S. drug regulators on Wednesday will issue a public health advisory about the potential risks of a pain drug made by Cephalon Inc, an agency official said.