FDA to review licenses to Vioxx, Celebrex, Bextra, other OTC drugs
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The Food and Drug Administration of the US found itself in the midst of a rather unpleasant controversy. Recently the chief of Cleveland Clinic Foundationâs department of cardiovascular medicine blamed this
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The federal Food and Drug Administration approved new labeling Thursday for Pfizer Inc.&#39;s Bextra drug to warn of possible serious skin reactions and heart-related problems for those who&#39;ve experienced coronary bypass surgery.
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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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Medicines used by millions of  Americans to relieve aches and pains will come under intense  scrutiny starting Wednesday as U.S. scientists scour dozens of  studies to determine if the drugs risk damaging the heart like  Merck & Co. Inc.'s withdrawn arthritis pill Vioxx.
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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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Drugmaker Merck has set up an independent committee to review the firm&#39;s actions prior to the withdrawal of its painkiller Vioxx from the market in September.
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London - The European Medicines Agency said on Friday it has been asked by the European Commission to conduct a review of certain arthritis drugs after the worldwide withdrawal of Merck &amp; Company&#39;s Vioxx medication.
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The spotlight is likely to be on Pfizer on Wednesday when federal drug regulators begin hearings on cox-2 drugs, the medicines that include Celebrex and Bextra.
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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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The US Food and Drug Administration on Thursday ordered the review of preventative studies involving Pfizer Inc.&#39;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 withdrawal of Vioxx from the market in September and more recent concerns about its cousin Bextra have raised safety questions about this entire class of painkillers
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Nov. 5, 2004 -- FDA officials announced Friday that they will launch a review of the agency&#39;s drug monitoring policies in the wake of recent high-profile safety concerns about widely used drugs, including antidepressants and Vioxx.
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FRIDAY, Oct. 8 (HealthDayNews) -- A week after drug giant Merck & Co. withdrew its arthritis drug Vioxx from the market, doubts are being raised about the safety of the two other approved medications in this class, Bextra and Celebrex.
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WASHINGTON - Americans should feel reasonably safe taking government-approved prescription drugs - with a few caveats - even after a popular arthritis medication was pulled from the market, medical experts say. But the problems with Vioxx raise questions about the Food and Drug Administration's safety review process and the length of time it took Merck to pull the drug, observers say...
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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 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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NEW YORK - On. Dec. 17, the US Food and Drug Administration released a statement relating to Pfizer&#39;s (nyse: PFE - news - people ) Celebrex.