Safety Alerts & Recalls
Search all Safety Alerts & Recalls
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
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.