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

NAPROXEN - Long-term study indicates cardiovascular risk

USA. The US FDA is alerting healthcare providers to emerging information from a long-term prevention trial, the Alzheimer's Disease Anti- Inflammatory Prevention Trial (ADAPT), that the risk of cardiovascular and cerebrovascular events may increase among patients taking naproxen, a non-steroidal antiinflammatory drug (NSAID).

The US FDA will be analysing all available information from these studies to determine whether additional regulatory action is needed. In the meantime, prescribers are cautioned:

• to carefully weigh the benefits and risks in patients currently on naproxen therapy,
• to always prescribe within the recommended dose of 250-500 mg twice a day and,
• to advise patients to adhere to the recommended daily dose indicated in over-thecounter naproxen preparations.

Several of the cyclooxygenase-2 (enzyme) specific inhibitor drugs (rofecoxib, celecoxib etc.) are currently under investigation for a full understanding of their adverse cardiovascular effects (see WHO Pharmaceuticals Newsletter No. 5, 2004 and section under 'Celecoxib' in this issue). Naproxen, a nonselective over-the-counter NSAID, is also being investigated to determine appropriate regulatory action. The US FDA is planning an advisory committee meeting in February 2005 to discuss the issues surrounding these drugs.


FDA Alert for Health-care Providers (Naproxen), 23 December 2004. Available on the Internet at www.fda.gov

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