WHO Pharmaceuticals Newsletter 2005, No. 01
(2005; 12 pages) Ver el documento en el formato PDF
Índice de contenido
Abrir esta carpeta y ver su contenidoREGULATORY MATTERS
Cerrar esta carpetaSAFETY OF MEDICINES
Ver el documentoATAZANAVIRRITONAVIR - Not to be coadministered with omeprazole
Ver el documentoCELECOXIB - Increased risk of cardiovascular events
Ver el documentoDARBEPOETIN ALFA - Adverse outcomes associated with off-label dosing strategies
Ver el documentoGALANTAMINE - Ineffective and possibly unsafe in mild cognitive impairment
Ver el documentoGLUCOSAMINE - Concerns about hypercholesterolaemic effects
Ver el documentoNAPROXEN - Long-term study indicates cardiovascular risk
Ver el documentoNEVIRAPINE - Not recommended in women with CD4+ cell counts greater than 250 cells/mm3
Ver el documentoPROPOFOL - Adverse events with both low- and high-rate infusions
Ver el documentoROSUVASTATIN - More reports of rhabdomyolysis
Abrir esta carpeta y ver su contenidoDRUGS OF CURRENT INTEREST
Abrir esta carpeta y ver su contenidoFEATURE
 

NEVIRAPINE - Not recommended in women with CD4+ cell counts greater than 250 cells/mm3

USA. The US FDA issued a public health advisory to inform health-care providers and patients about recent safety-related changes to the nevirapine (Viramune) label and about appropriate use of HIV triple combination therapy containing nevirapine, a treatment option in the United States which is increasingly being used globally. The Indications and Usage section now recommends against starting nevirapine treatment in women with CD4+ cell counts greater than 250 cells/mm3 unless benefits clearly outweigh risks. This recommendation is based on a higher observed risk of serious liver toxicity in patients with higher CD4+ cell counts prior to initiation of therapy. Females have a 3-fold higher risk of symptomatic liver toxicity than males, and females with CD4+ cell counts > 250 cells/mm3 have a 12-fold higher risk of symptomatic liver toxicity than females with CD4+ cell counts < 250 cells/mm3. In addition, the revised label now includes a Medication Guide to inform patients about risks associated with nevirapine when used for the treatment of HIV.

Reference:

FDA Public Health Advisory for Nevirapine, 20 January 2005. Available on the Internet at www.fda.gov

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