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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U.S. regulators said on Friday they would review whether to take action over Merck & Co Inc's and Schering-Plough Corp's popular cholesterol medicine Vytorin after a study showed it was no better than a generic drug in preventing the build-up of fatty plaque.
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A veteran U.S. Food and Drug  Administration scientist will unveil new data on Thursday  before an expert panel charged with determining whether pain  relievers similar to Merck & Co. Inc.'s now-withdrawn Vioxx  should remain on the market.
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The US Food and Drug Administration is considering further regulatory measures, including withdrawal from the market, of Pfizer&#39;s arthritis treatment Celebrex.
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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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More patients with serious diseases could get experimental drugs under revised rules proposed on Monday by the U.S. Food and Drug Administration that also detail how manufacturers can charge for them.
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The Food and Drug Administration should immediately yank Celebrex and Bextra from the market to protect Americans from the drugs' heart risks, according to a petition filed with the agency yesterday by Public Citizen. The petition also requests that the FDA freeze applications for Arcoxia and Prexige -- two painkillers under development -- for the same reason.
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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.
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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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The Food and Drug Administration yesterday ordered a review of all prevention studies involving drugs such as Celebrex and Bextra, which have been associated with increased risk of heart problems. The agency also urged the public to limit use of over-the-counter pain medications.
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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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Soon after the anti-arthritis and painkiller drug Vioxx was approved by the Food and Drug Administration in 1999, credible questions surfaced about the risk of serious cardiovascular problems in people who took it.
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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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Americans should feel reasonably safe taking government-approved prescription drugs &#151; with a few caveats &#151; 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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The US Food and Drug Administration (news - web sites) 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 &amp; Co.
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Pfizer Inc. PFE.N said on Friday it  is sending additional information to healthcare professionals  about its arthritis drug Bextra, a COX-2 product in the same  class as the withdrawn drug Vioxx.
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Responding to public criticism of its handling of the controversial arthritis drug Vioxx, the US Food and Drug Administration on Wednesday defended its oversight of the monitoring process and said it acted in the best interests of the public&#39;s safety.