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FDA: Ongoing Safety Review of Stalevo and Possible Increased Risk of Heart Attack and Stroke
The U.S. Food and Drug Administration (FDA) is reviewing data from several clinical research studies that suggest patients taking Stalevo (a combination of carbidopa/levodopa and entacapone) may be at an increased risk for heart attack, stroke, and heart-related death compared to those taking carbidopa/levodopa (sold as the combination product, Sinemet). Both Stalevo and Sinemet are effective treatments for the symptoms of Parkinson's disease. Adding entacapone to carbidopa/levodopa can lead to a greater degree of improvement in some of the symptoms of Parkinson's disease. Stalevo contains a combination of the active ingredients entacapone, carbidopa, and levodopa. Entacapone is also available as a single-ingredient product sold under the brand name Comtan. Both Stalevo and Comtan are used to treat symptoms of Parkinson's disease. For more information, please visit: http://www.fda.gov/Drugs/DrugSafety/ucm223060.htm
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Updated Prescribing Information
Baraclude (entecavir) Tablets and Oral Solution Audience: Infectious disease specialists and other healthcare professionals [UPDATE 08/16/2007] FDA and Bristol-Myers Squibb notified healthcare professionals of revisions to the following sections of the Baraclude prescribing information: BOXED WARNINGS, MICROBIOLOGY/Antiviral Activity against HIV (human immunodeficiency virus), WARNINGS/Co-infection with HIV, PRECAUTIONS/Information for Patients, and Patient Package Insert. Baraclude therapy is not recommended for HIV/hepatitis B virus (HBV) co-infected patients who are not also receiving highly active antiretroviral therapy (HAART) due to the potential for the development of HIV resistance. [Posted 02/24/2007] FDA and Bristol-Myers Squibb notified healthcare professionals of revisions to the MICROBIOLOGY/Antiviral Activity and INDICATIONS AND USAGE/Description of Clinical Studies/Special Populations sections of the prescribing information for Baraclude. The revised labeling is the result of a case report in which a human immunodeficiency virus (HIV) variant containing the M184V resistance substitution was documented during Baraclude treatment for chronic hepatitis B virus (HBV) infection in an HIV/HBV co-infected patient who was not simultaneously receiving highly active antiretroviral therapy (HAART). Current treatment guidelines recommend Baraclude as an option for treatment of HBV in the HIV/HBV co-infected adult patient who does not qualify for HAART. Healthcare professionals are advised that when considering therapy with Baraclude in an HIV/HBV co-infected patient not receiving HAART, the risk of developing HIV resistance cannot be excluded based on current information.
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Date Published Title Drug Source
2010-08-20 FDA: Ongoing Safety Review of Stalevo and Possible Increased Risk of Heart Attack and Stroke Entacapone FDA
2007-08-16 Updated Prescribing Information Entecavir FDA
2011-03-17 Primatene Mist With Chlorofluorocarbons No Longer Available After Dec. 31, 2011 Epinephrine FDA
2011-09-22 Users of Primatene Mist Will Need a Prescription Product to Treat Their Asthma Epinephrine FDA
2007-11-09 Strengthened box warning for cancer and chronic kidney failure Epoetin Alfa FDA
2008-08-01 FDA Recommends Limits on Use of Erythropoiesis Stimulating Agents in Cancer Patients Epoetin Alfa FDA
2009-08-27 Two Recent Studies Support Safety Concerns of Erythropoiesis Stimulating Agent Use in Cancer Patient Epoetin Alfa MediGuard CRT
2010-02-16 The FDA Requires a Risk Management Program for Erythropoiesis-Stimulating Agents (ESAs) Epoetin Alfa FDA
2010-09-24 Amgen Issues Epogen/Procrit Voluntary Recall: Glass Flakes Found in VIals Epoetin Alfa Manufacturer
2011-06-24 FDA Modifies Dosing Recommendations for Erythropoiesis-Stimulating Agents Epoetin Alfa FDA
2007-11-09 Strengthened box warning for cancer and chronic kidney failure FDA
2008-01-03 FDA Communication Regarding New Anemia Drug Studies FDA
2008-08-01 FDA Recommends Limits on Use of Erythropoiesis Stimulating Agents in Cancer Patients FDA
2010-06-15 FDA Warns Consumers About Correct Vitamin D Supplementation for Infants Ergocalciferol FDA
2008-09-23 Use Tarceva (Erlotinib) with Caution in Patients with Liver Problems Erlotinib Manufacturer
2009-05-09 New Warnings Added to the Labeling of Tarceva Erlotinib FDA
2012-08-09 Fougera Pharmaceuticals, Inc. Recalls Single Lot of Erythromycin Topical Solution USP, 2% Erythromycin FDA
2009-01-12 New Antidepressant Guide for Patients Escitalopram FDA
2008-09-18 Long-term use of proton pump inhibitors (PPIs) may increase risk of fractures Esomeprazole MediGuard CRT
2008-11-13 Early Communication about Potential Drug Interaction Between PLAVIX and PROTON PUMP INHIBITORS Esomeprazole MediGuard CRT
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