WHO Pharmaceuticals Newsletter 2005, No. 01
(2005; 12 pages) Ver el documento en el formato PDF
Índice de contenido
Cerrar esta carpetaREGULATORY MATTERS
Ver el documentoAMIODARONE - Medication Guide to be dispensed along with medicine
Ver el documentoATOMOXETINE - Labelling to include liver injury warning
Ver el documentoBENZATHINE BENZYL-PENICILLIN/PROCAINEBENZYLPENICILLIN - Label changes highlight appropriate use
Ver el documentoMEFLOQUINE - Patient Information Leaflet to help recognize adverse symptoms
Ver el documentoPARACETAMOL-DEXTROPROP-OXYPHENE - To be withdrawn due to risk of toxicity in overdose
Ver el documentoSMALLPOX VACCINE - Label to highlight reports of myopericarditis
Ver el documentoTHIORIDAZINE - Withdrawn due to poor benefit/risk profile
Abrir esta carpeta y ver su contenidoSAFETY OF MEDICINES
Abrir esta carpeta y ver su contenidoDRUGS OF CURRENT INTEREST
Abrir esta carpeta y ver su contenidoFEATURE

SMALLPOX VACCINE - Label to highlight reports of myopericarditis

USA. A black box warning has been added to the labelling of Wyeth's smallpox vaccine, Dryvax, to highlight reports of acute myopericarditis in healthy adults. Although Wyeth no longer manufactures Dryvax, as the World Health Assembly certified the world free of naturally occurring smallpox in the 1980s, the US Government asked Wyeth to test stored batches of the vaccine, and the black box warning applies to those vaccines which have been repackaged for immediate use by firefighters, medical personnel and other first responders. The black box warning states that "acute myopericarditis has been observed after administration of Dryvax to healthy adults", and also warns of encephalitis, progressive vaccinia and severe vaccinial skin infections following vaccination with the agent. The warning states that immunocompromised persons should not receive the vaccine in non-emergency situations.


Smallpox vaccine dried, calf lymph type. Prescribing Information, 15 November 2004. Available on the Internet at www.fda.gov

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