WHO Pharmaceuticals Newsletter 2005, No. 01
(2005; 12 pages) View the PDF document
Table of Contents
Close this folderREGULATORY MATTERS
View the documentAMIODARONE - Medication Guide to be dispensed along with medicine
View the documentATOMOXETINE - Labelling to include liver injury warning
View the documentBENZATHINE BENZYL-PENICILLIN/PROCAINEBENZYLPENICILLIN - Label changes highlight appropriate use
View the documentMEFLOQUINE - Patient Information Leaflet to help recognize adverse symptoms
View the documentPARACETAMOL-DEXTROPROP-OXYPHENE - To be withdrawn due to risk of toxicity in overdose
View the documentSMALLPOX VACCINE - Label to highlight reports of myopericarditis
View the documentTHIORIDAZINE - Withdrawn due to poor benefit/risk profile
Open this folder and view contentsSAFETY OF MEDICINES
Open this folder and view contentsDRUGS OF CURRENT INTEREST
Open this folder and view contentsFEATURE
 

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.

Reference:

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

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