Vidyya Medical News Service
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Volume 7 Issue 64 Published - 14:00 UTC 08:00 EST 5-Mar-2005 Next Update - 14:00 UTC 08:00 EST 6-Mar-2005
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U.S. marshals seize lots of GlaxoSmithKline's Paxil CR and Avandamet tablets because of continuing manufacturing violations
In a response to ongoing concerns about manufacturing quality, the Food and Drug Administration (FDA) and the Department of Justice today initiated seizures of Paxil CR and Avandamet tablets manufactured by GlaxoSmithKline, Inc. (GSK). Manufacturing practices for the two drugs, approved to treat depression and panic disorder (Paxil CR) and Type II Diabetes (Avandamet), failed to meet the standards laid out by FDA that ensure product safety, strength, quality and purity. more

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Questions and answers about the seizure of Paxil CR and Avandamet
FDA and the Department of Justice have filed three actions in federal court to seize remaining stocks of these products (Avandamet and Paxil CR) in three locations. The seizures are meant to prevent further distribution of the products.  more

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Prescribing information: Revised label -- Crestor (rosuvastatin calicum)
FDA issued a public health advisory describing revisions to the warnings, dosage and administration, clinical pharmacology, and precautions sections of the labeling. The revisions include results from a Phase 4 pharmacokinetic study in Asian-Americans and highlight important information on the safe use of Crestor to reduce the risk for serious muscle toxicity (myopathy/rhabdomyolysis), especially at the highest approved dose of 40 mg. At this time, the FDA is also making statements about the muscle and kidney safety of Crestor based on extensive review of available information. more

 


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Preventing diabetes complications could save $2.5 billion annually
A new research synthesis from HHS' Agency for Healthcare Research and Quality estimates that the nation could save nearly $2.5 billion a year by preventing hospitalizations due to severe diabetes complications.  more

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Economic and health costs of diabetes
This Highlight summarizes findings from AHRQ's Healthcare Cost and Utilization Project (HCUP) using hospital care data to examine how diabetes-related complications affect health status, hospitalizations, and economic costs.  more

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Improving the quality of diabetes care: New tools for states
The Agency for Healthcare Research and Quality (AHRQ) has developed Diabetes Care Quality Improvement: A Resource Guide for State Action and its companion workbook, Diabetes Care Quality Improvement: A Workbook for State Action. These materials were designed in partnership with the Council of State Governments to help States assess the quality of diabetes care and create quality improvement strategies.  more

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Improving care for diabetes patients through intensive therapy and a team approach
Diabetes is the sixth leading cause of death in the United States and proper treatment can be complex. This synthesis provides good evidence to show that intensive therapy using a team approach is an effective way to reach the major goals of diabetes therapy: lowering glucose (blood sugar) to appropriate levels and avoiding or postponing the onset of serious complications. more

 
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