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The FDA is issuing a public health advisory concerning use of non-steroidal anti-inflammatory drug products (NSAIDS) including those known as COX-2 selective agents. Recently released data from controlled clinical trials showing that the COX-2 selective agents (Vioxx, Celebrex, and Bextra) may be associated with an increased risk of serious cardiovascular events (heart attack and stroke) especially when they are used for long periods of time or in very high risk settings (immediately after heart surgery). Click here to read the entire advisory. FDA Issues Public Health Advisory Recommending Limited Use of Cox-2 Inhibitors - Agency Requires Evaluation of Prevention Studies Involving Cox-2 Selective AgentsFDA Talk Paper - December 23, 2004The Food and Drug Administration (FDA) today issued a Public Health Advisory summarizing the agency's recent recommendations concerning the use of non-steroidal anti-inflammatory drug products (NSAIDs), including those known as COX-2 selective agents. The public health advisory is an interim measure, pending further review of data that continue to be collected. In addition, FDA today announced that it is requiring evaluation of all prevention studies that involve the Cox-2 selective agents Celebrex (celecoxib) and Bextra (valdecoxib) to ensure that adequate precautions are implemented in the studies and that local Institutional Review Boards reevaluate them in light of the new evidence that these drugs may increase the risk of heart attack and stroke. A prevention trial is one in which healthy people are given medicine to prevent a disease or condition (such as colon polyps or Alzheimer's disease). Click here to read the entire paper. ---------------------------------------------------------------------- FDA Statement on the Halting of a Clinical Trial of the Cox-2 Inhibitor CelebrexFDA Statement - December 17, 2004The FDA today released the following statement on the halting of a clinical trial of the Cox-2 inhibitor Celebrex (celecoxib): The Food and Drug Administration (FDA) learned last night from the National Cancer Institute (NCI) and Pfizer, Inc., that NCI has stopped drug administration in an ongoing clinical trial investigating a new use of Celebrex (celecoxib) to prevent colon polyps because of an increased risk of cardiovascular (CV) events in patients taking Celebrex versus those taking a placebo. Click here to read the entire story. ---------------------------------------------------------------------- Modern drugs provide unmistakable and significant health benefits. It is well recognized that FDA's drug review is a gold standard. Indeed, we believe that FDA maintains the highest worldwide standards for drug approval. FDA grants approval to drugs after a sponsor demonstrates that they are safe and effective. Experience has shown that the full magnitude of some potential risks do not always emerge during the mandatory clinical trials conducted before approval to evaluate these products for safety and effectiveness. Occasionally, serious adverse effects are identified after approval either in post-marketing clinical trials or through spontaneous reporting of adverse events. That is why Congress has supported and FDA has created a strong post-market drug safety program designed to assess adverse events identified after approval for all of the medical products it regulates as a complement to the pre-market safety reviews required for approval of prescription drugs in the United States. Monitoring the drug safety of marketed products requires close collaboration between our clinical reviewers and drug safety staff to evaluate and respond to adverse events identified in ongoing clinical trials or reported to us by physicians and their patients. The most recent actions concerning the drug Vioxx (rofecoxib) illustrates the vital importance of the ongoing assessment of the safety of a product once it is in widespread use. Click here to read the entire statement. ---------------------------------------------------------------------- BERNE (Nov. 5) - Drug giant Merck & Co. Inc. should have pulled its Vioxx painkiller from the market four years ago because data showing it raised the risk of heart attacks has existed since 2000, Swiss scientists said on Friday. In a report for British medical journal The Lancet, researchers at the University of Berne said there was substantial evidence of the dangerous side effects of the drug by the end of 2000, but the mounting data was not analyzed properly. Click here to read the entire story. ---------------------------------------------------------------------- NEW YORK -- Pfizer Inc. defended the safety of its painkiller Celebrex on Thursday after a newspaper reported that documents from Canadian health authorities linked the drug to the deaths of 14 people who were taking it over the past five years. The documents include more than 100 adverse-reaction reports on Celebrex over the past five years, including 19 cases of heart attack, cardiac arrest or heart failure and five strokes, the Canadian newspaper National Post reported. Click here to read the entire story. ---------------------------------------------------------------------- TORONTO - Canadian health officials said Thursday they have received reports linking Pfizer painkiller Celebrex to 14 deaths and numerous heart-related side effects, but that it would be premature to issue a warning or pull it from the shelves. Click here to read the entire story. ----------------------------------------------------------There are many other treatment options for people with arthritis, and physicians are considering them patient by patient.By Susan J. Landers AMNews staff October 25, 2004Washington -- Physicians are pulling out their risk-versus-benefit calculators once more to determine which patients, if any, should be switched to another COX-2 inhibitor in light of the fate of the popular drug Vioxx (rofecoxib), which was pulled from the market abruptly Sept. 30. Click here to read the entire story. ----------------------------------------------------------Merck Pulls Arthritis Drug Vioxx from MarketAll Things Considered - NPR - September 30, 2004Pharmaceutical giant Merck & Co. is pulling its arthritis drug Vioxx from the market after a study confirmed earlier concerns that it raises the risk of heart problems, including heart attacks and stroke. Vioxx is currently used by 2 million people worldwide and has been used by more than 84 million people around the world, according to Merck. Click here to read the entire story.
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