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Statin Benefits Still Outweigh New Safety Information
A study published today in the medical journal "The Lancet" has reported that statins, a class of medicine used to treat high cholesterol, may be associated with a slightly increased risk of developing diabetes. Researchers who conducted the study found an extra case of diabetes for every 255 patients treated with a statin after four years - a significant finding - but still substantially lower than the five cardiovascular events these statins were found to prevent in the same group. Statins are a class of cholesterol-lowering medications that include atorvastatin (Lipitor), fluvastatin (Lescol, Lescol XL), lovastatin (Altoprev, Mevacor), pitavastatin (Livalo), pravastatin (Pravachol), rosuvastatin (Crestor), and simvastatin (Zocor). Statins are also included in several combination products including Advicor, Caduet, Simcor, and Vytorin. For more information, please visit: http://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2809%2961965-6/fulltext
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The FDA Requires a Risk Management Program for Erythropoiesis-Stimulating Agents (ESAs)
The FDA is requiring all drugs called Erythropoiesis-Stimulating Agents (ESAs) to be prescribed and used under a risk management program, known as a risk evaluation and mitigation strategy (REMS), to ensure the safe use of these drugs. The ESAs that are part of the REMS are marketed under the names EPOGEN, PROCRIT, and ARANESP. The FDA required the manufacturers of these products to develop a risk management program because studies show that ESAs can increase the risk of tumor growth and shorten survival in patients with cancer who use these products. Studies also show that ESAs can increase the risk of heart attack, heart failure, stroke or blood clots in patients who use these drugs for other conditions. As part of the REMS, a Medication Guide explaining the risks and benefits of ESAs must be provided to all patients receiving EPOGEN, PROCRIT, or ARANESP. In addition to the Medication Guide, the ESA APPRISE (Assisting Providers and Cancer Patients with Risk Information for the Safe use of ESAs) Oncology program will provide special training to healthcare professionals about the use of ESAs in patients with cancer. For more information, please visit: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm200297.htm
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Date Published Title Drug Source
2010-02-17 Statin Benefits Still Outweigh New Safety Information Atorvastatin MediGuard CRT
2010-02-16 The FDA Requires a Risk Management Program for Erythropoiesis-Stimulating Agents (ESAs) Epoetin Alfa FDA
2010-02-05 Risk of Progressive Multifocal Leukoencephalopathy (PML) Increases with the Number of Tysabri (Natalizumab) Infusions Received Natalizumab FDA
2010-02-03 Voluntary Recall of Additional Lots of Sanofi Pasteur H1N1 Vaccine Manufacturer
2010-02-02 Lilly Changes Zyprexa Prescribing Information for Indication for Use in Adolescents (Ages 13 to 17) Fluoxetine with Olanzapine Manufacturer
2010-01-29 Serious Liver Disorder Associated with the Use of Didanosine (Marketed as Videx and Videx EC) Didanosine FDA
2010-01-29 Biogen Idec Announces Monthly Update of Tysabri Monitoring Program Natalizumab Manufacturer
2010-01-28 Recall of Several Lots of Enbrel (etanercept) SureClick Autoinjector, 50 mg/mL Etanercept FDA
2010-01-28 Additional Recall on Milk of Magnesia: Mint Flavor and Original Flavor FDA
2010-01-27 Change to Prescribing Information for VELCADE to Include Dosage Adjustment in Liver Impairment Manufacturer
2010-01-26 Update on FDA Warning About Counterfeit Alli Orlistat FDA
2010-01-26 Recall of GlucoPro Insulin Syringes Insulin Glargine Manufacturer
2010-01-26 Recall of GlucoPro Insulin Syringes NPH Insulin Manufacturer
2010-01-26 Recall of GlucoPro Insulin Syringes Insulin Glulisine Manufacturer
2010-01-26 Recall of GlucoPro Insulin Syringes Manufacturer
2010-01-26 Recall of GlucoPro Insulin Syringes Manufacturer
2010-01-26 Recall of GlucoPro Insulin Syringes Insulin Aspart Manufacturer
2010-01-26 Recall of GlucoPro Insulin Syringes Insulin Lispro Manufacturer
2010-01-26 Recall of GlucoPro Insulin Syringes Insulin Detemir Manufacturer
2010-01-26 Recall of GlucoPro Insulin Syringes Insulin Manufacturer