FDA Bans Vioxx And Bextra Critic From Advisory Panel Meeting
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A drug safety expert says his invitation to participate in a meeting on the risks of arthritis drugs like Vioxx and Bextra has been rescinded by government officials because he publicly expressed concerns about the medications.
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The U.S. Food and Drug Administration said on Tuesday it was creating an independent drug safety board after the agency's monitoring of drugs already in the marketplace was criticized amid the withdrawal of arthritis drug Vioxx.
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Merck &amp; Co.&#39;s recall of the Vioxx painkiller shows why the US Food and Drug Administration needs its safety monitors to be independent of those who approve new medicines, FDA scientist David J. Graham told a Senate hearing.
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Pfizer Inc. on Wednesday defended  its arthritis drug Bextra after a prominent cardiologist said a  pooled analysis of clinical trial results showed patients  taking the drug were twice as likely to have a heart attack or  stroke as those taking a placebo.
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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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An advisory panel of experts recommended unanimously yesterday that the Food and Drug Administration reject a new weight-loss drug after hearing testimony that it increases the risk of suicidal behavior.
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Doctors should limit use of Pfizer Inc.&#39;s Celebrex and Bextra pain drugs while regulators continue to weigh their cardiovascular risks, the US Food and Drug Administration said today.
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The new warning states that Bextra should not be used in patients undergoing heart bypass surgery. In October, Bextra&#39;s manufacturer, Pfizer, announced results of a study showing an increase in heart problems in patients having heart bypass surgery.
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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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Washington - An expert with the United States Food and Drug Administration (FDA) has said on Thursday he was pressured by his agency to stifle study results showing the potential dangers of the anti-inflammatory drug Vioxx.
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NEW YORK  - Pfizer dismissed a report on the safety of its pain reliever Bextra, but the new controversy weighed on the stock price of the US pharmaceutical giant.
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WASHINGTON Dec 9, 2004 - The government is warning of potential heart problems associated with the use of the painkiller Bextra in people who have recently had heart bypass surgery.
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Drug maker Merck &amp; Co. reported Tuesday that its board appointed a special committee to review the company&#39;s actions before withdrawing blockbuster arthritis drug Vioxx from the market Sept.
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US health regulators recommended on Thursday that doctors limit prescribing painkillers like Pfizer Inc.&#39;s Celebrex and Bextra, in light of recent evidence that they may increase the risk of heart attack and stroke.
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BETHESDA, Md.  - A U.S. advisory panel on Friday  urged regulators to reject over-the-counter sales of Merck &  Co. Inc.'s cholesterol-lowering drug Mevacor because of doubts  the medicine could be used safely without a doctor's guidance.
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Oct. 15, 2004 -- Bextra -- one of two US approved Vioxx sister drugs -- may cause rare skin and heart side effects, its manufacturer today warned doctors.
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The Food and Drug Administration yesterday called for an evaluation of all prevention studies involving two controversial painkillers - Celebrex and Bextra - to ensure adequate protection for participants who use the pills.