WHO Pharmaceuticals Newsletter 2005, No. 01
(2005; 12 pages) View the PDF document
Table of Contents
Open this folder and view contentsREGULATORY MATTERS
Close this folderSAFETY OF MEDICINES
View the documentATAZANAVIRRITONAVIR - Not to be coadministered with omeprazole
View the documentCELECOXIB - Increased risk of cardiovascular events
View the documentDARBEPOETIN ALFA - Adverse outcomes associated with off-label dosing strategies
View the documentGALANTAMINE - Ineffective and possibly unsafe in mild cognitive impairment
View the documentGLUCOSAMINE - Concerns about hypercholesterolaemic effects
View the documentNAPROXEN - Long-term study indicates cardiovascular risk
View the documentNEVIRAPINE - Not recommended in women with CD4+ cell counts greater than 250 cells/mm3
View the documentPROPOFOL - Adverse events with both low- and high-rate infusions
View the documentROSUVASTATIN - More reports of rhabdomyolysis
Open this folder and view contentsDRUGS OF CURRENT INTEREST
Open this folder and view contentsFEATURE
 

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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