Merck & Co. faces a dual threat from health insurers and patients' lawyers, after a U.S. study suggested its Vioxx arthritis drug carries a greater risk than rival medicines. Health insurers on Thursday said they may further restrict payments for the drug, and attorneys already involved in product-liability lawsuits against Merck said the findings would bolster their cases. The study, financed by the U.S. Food and Drug Administration (news - web sites) and released Wednesday, is the latest to link Vioxx to heart attacks. That news pushed Merck shares down 2 percent. Aetna Inc., one of the biggest health insurers, may cast more doubt on Vioxx and similar drugs, when it releases data from a similar analysis within weeks, the company said. The company is submitting its study to a medical journal for review by other doctors. The FDA (news - web sites) and Aetna reviews follow a widely publicized article in 2001 that found the entire class of painkillers known as Cox-2 inhibitors, which include Vioxx and Pfizer Inc's Celebrex, might cause blood clots that trigger heart attack and stroke. The Cox-2 drugs are designed to fight inflammation and pain while reducing the risk of ulcers caused by over-the-counter pain medication, such as aspirin and ibuprofen. Many big health insurers such as WellPoint Health Networks Inc. and Cigna Corp. already make it difficult to get Vioxx because of the safety issues, by requiring a doctor to get special permission from the HMO for a prescription, informs Reuters. According to KFMB TV, One of the nation's biggest HMO’s may be reconsidering it's endorsement of the popular prescription medication, Vioxx, after a new study found some potentially disturbing data. Results from an FDA funded study are showing a potential link between the arthritis drug, Vioxx and heart attacks and deaths in its users. The administration looked at the records of more than a million Kaiser Permanente patients. They discovered that Vioxx users had a 50 percent greater chance of problems than people using a competing Cox-2 inhibitor, like Celebrex. The news raises a red flag for Kaiser decision-makers. “So as with any new study that comes out, Kaiser Permanente will review it's use of Vioxx along with the physicians to come to a determination whether Vioxx will be continued to be used by our patients or not,” said Shawn Briere who is a pharmacist with Kaiser Permanente. Kaiser officials say they want to spend several weeks looking at more data, before deciding whether to discontinue writing prescriptions for Vioxx. However, the theory that Cox-2 inhibitors cause heart problems is not entirely unfounded. The company said more than 24,000 patients have been treated with Vioxx in controlled clinical trials and that there was no significant difference in the rate in adverse cardiovascular events between those patients taking Vioxx versus those on placebo. Merck said the reported increase in cardiovascular adverse events was taken from studies looking at patients who took 50 mg of Vioxx once per day, or twice the recommended chronic dose of Vioxx, compared with patients taking 500 mg of the nonsteroidal anti-inflammatory drug naproxen. At these doses, the company said 45 serious cardiovascular adverse events occurred in 4,047 patients taking Vioxx compared to the 19 events of the 4,029 patients taking naproxen. Out of these events, 18 of the events were nonfatal heart attacks in the Vioxx arm compared to 4 in the naproxen arm. The company said deaths related to these events were nearly similar, with 7 in the Vioxx arm and 6 in the naproxen arm. The company said studies show no increased risk for patients taking Vioxx in the recommended 12.5 mg and 25 mg doses. Shares of Merck were down $1.07, or 2.3 percent, at $44.95 in morning trading on the New York Stock Exchange, reports Forbes.
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