WHO Pharmaceuticals Newsletter 2005, No. 04
(2005; 15 pages) View the PDF document
Table of Contents
Close this folderREGULATORY MATTERS
View the documentAmfetamine - Reintroduced with revised prescribing and patient information
View the documentAtomoxetine - Risk of suicidal thoughts
View the documentBacitracin, Fusafungine, Gramicidin, Tyrothricin - Locally administered products withdrawn
View the documentDuloxetine - Reports of adverse hepatic effects
View the documentFentanyl transdermal system - Labels updated for safe and appropriate use
View the documentHexavac - Suspended due to concerns about longterm effects against hepatitis B
View the documentMedroxyprogesterone - Loss of bone mineral density
View the documentMeloxicam - Juvenile rheumatoid arthritis indication: label updated
View the documentNabumetone - Stronger labelling for renal effects
View the documentNon-selective NSAIDs - No changes to current prescribing practice
View the documentParoxetine - Potential risk in pregnancy
View the documentThioridazine - Sale discontinued in Canada
Open this folder and view contentsSAFETY OF MEDICINES
Open this folder and view contentsFEATURE
 

Hexavac - Suspended due to concerns about longterm effects against hepatitis B

Europe. The European Medicines Agency has recommended the suspension of the marketing authorization for Hexavac. This is a precautionary measure taken amidst concerns about the vaccine's long-term protection against hepatitis B following the identification of a decreased immunogenicity of the hepatitis B component in the vaccine. Hexavac is a vaccine for infants and children against diphtheria, tetanus, whooping cough (pertussis), hepatitis B virus, polio virus and Hemophilus influenzae type b.

The current concern does not affect the protection against diphtheria, tetanus, whooping cough, polio and Hemophilus influenzae type b. Sanofi Pasteur MSD, the marketing authorization holder, has been directed to design a specific surveillance programme to determine whether infant and children, already vaccinated with Hexavac, would need to be revaccinated at a later stage, to ensure long-term protection against hepatitis B.

Reference:

Press release. European Medicines Agency, 15 September 2005 (http://www.emea.eu.int).

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