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 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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Drugs in the same category as Merck &amp; Co. Inc.&#39;s withdrawn Vioxx painkiller will get close scrutiny to see if they can also cause heart attacks, US Food and Drug Administration officials said on Thursday.
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Dr. Steven Galson, acting director of the Food and Drug Administration&#39;s Center for Drug Evaluation, announced Friday that the FDA will review five popular drugs whose safety is being questioned.
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Last weekâs dramatic withdrawal of the COX-2 inhibitor rofecoxib (Vioxx) is discussed in this weekâs lead editorial in THE LANCET, which comments that more vigilant drug licensing is vital to prevent the endangering of patientsâ health.
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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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The federal Food and Drug Administration said Friday that it would strengthen its safety and review process for pharmaceuticals already on the market to learn more about their possible side effects.
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US regulators warned yesterday of possible heart risks with Pfizer&#39;s Bextra, delivering another blow to popular pain drugs cox-2 inhibitors such as Vioxx, withdrawn from the market by Merck in September.
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The Food and Drug Administration on Thursday 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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THURSDAY, Dec. 23 (HealthDayNews) --  The U.S. Food and Drug Administration says it will review all prevention trials involving the prescription pain medications Celebrex and Bextra. These drugs are part of a category of drugs known as Cox-2 inhibitors.
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Drugs in the same category as Merck & Co. Inc.'s withdrawn Vioxx painkiller will get close scrutiny to see if they also can cause heart attacks, U.S. regulators said on Thursday.
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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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Merck &amp; Co. said the US Food and Drug Administration has requested additional safety and efficacy information on its Vioxx successor, Arcoxia, before it considers granting US approval for the drug.
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NEW YORK, December 24  - The Food &amp; Drug Administration (FDA) announced yesterday that it planned to examine the various studies that link the usage of several painkillers with heightened cardiovascular risks, while recommending that
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ROCKVILLE, Md.  - The U.S. 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 & Co. Inc.'s withdrawn painkiller  Vioxx.
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The U.S. 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 & Co. Inc.'s withdrawn painkiller Vioxx.
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The arthritis drug Bextra will begin carrying a warning on the label about possible heart and blood-clotting problems, the Food and Drug Administration said yesterday.