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Avandia (rosiglitazone) REMS (Risk Evaluation and Mitigation Strategy) document. |
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FDA: The goals of the Avandia-Rosiglitazone Medicines Access Program (hereafter referred to as the Rosiglitazone REMS Program) are:.................... 1. To restrict access to rosiglitazone-containing medicines (Avandia, Avandamet, Avandaryl) so that only prescribers who acknowledge the potential increased risk of myocardial infarction associated with the use of rosiglitazone are prescribing rosiglitazone................... 2. To restrict access to patients who have been advised by a healthcare provider about the potential increased risk of myocardial infarction associated with the use of rosiglitazone and are one of the following:................ • either already taking rosiglitazone or............... • if not already taking rosiglitazone, they are unable to achieve glycemic control on other medications and, in consultation with with their healthcare provider, have decided not to take pioglitazone for medical reasons.
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CMS offers new Accountable Care Organization options. |
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Nephronline: After facing criticism about the regulations for accountable care organizations, the Centers for Medicare & Medicaid Services announced three new initiatives designed to help doctors, hospitals and other health care providers become accountable care organizations.
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NKF will suspend U.S. Transplant Games for 2012 due to economic constraints |
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NKF: The National Kidney Foundation will not be hosting the U.S. Transplant Games in 2012. "For 20 years," says NKF CEO John Davis, "the NKF U.S. Transplant Games have educated the public about the life-saving power of organ donation and dramatically demonstrated that those with transplants can and do lead normal and active lives. But the Games represent a multi-million dollar expense for the foundation," he explains, "that also requires a significant commitment of staff resources."
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More on Avandia action by the FDA |
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USA Today: The diabetes drug Avandia will be pulled from retail pharmacy shelves in November because it poses such a big heart attack risk, the federal government announced Tuesday. The federal government is restricting prescriptions for Avandia. By Paul Sakuma, AP The federal government is restricting prescriptions for Avandia. Enlarge By Paul Sakuma, AP The federal government is restricting prescriptions for Avandia. Ads by Google Diabetes Drug LawsuitHeart Attack/Failure, Stroke? Get Your Case Reviewedavandiafdarecall.com What Causes Stroke?Understand the many factors that increase your risk of stroke.www.cdh.org Peripheral Neuropathy?Learn How Dr. Serpe Of Naperville Finally Gave Me Neuropathy ReliefNapervilleNeuropathy.com When the new program goes into effect on Nov. 18, only certified doctors will be allowed to prescribe the drug, and only to patients who've been informed of the risks and who will fill their prescriptions by mail order through specific pharmacies.
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FDA pulls Avandia (rosiglitazone) from retail pharmacy shelves. |
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FDA: FDA has modified the REMS for Avandamet and Avandaryl because previously, the REMS consisted of only a Medication Guide. The REMS, which now includes a restricted access and distribution program, applies to all three rosiglitazone products.
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