Other safety alerts
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| Australia: Rotavirus Vaccination and Risk of Intussusception |
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The Therapeutic Goods Administration, Australia, has undertaken an investigation of a possible association between the use of the rotavirus vaccines Rotarix® (GSK) and RotaTeq® (Merck/CSL) and the occurrence of a rare form of bowel obstruction known as intussusception (IS). Intussusception is a condition caused by the telescoping of one segment of the bowel into another. This interim analysis provides evidence that both registered rotavirus vaccines are likely to be associated with an increase in risk of IS in the 7 days following the first dose of both Rotarix and RotaTeq. Despite the identification of a small increase in risk of IS following the first dose of rotavirus vaccination, the TGA considers that the overall risk benefit balance of both vaccines remains positive. It is also important to note that both the World Health Organization (WHO) and the Australian Technical Advisory Group on Immunisation (ATAGI) have recommended the continued use of rotavirus vaccine for infants. The Product Information documents for both vaccines will be amended to reflect these findings.
Please refer to the following website in Australia for details:
http://www.tga.gov.au/safety/alerts-medicine-rotavirus-110225.htm
In Hong Kong, Rotarix Vaccine Oral Suspension (HK-54546) is registered by Glaxosmithkline Limited, and RotaTeq Oral Vaccine (HK-55037) is registered by Merck Sharp & Dohme (Asia) Limited. Both Rotarix and RotaTeq are prescription drugs. Any further updates made by the TGA and other regulatory authorities will be kept in view. Letter to inform healthcare professionals about the updated safety information will be issued.
Ends/ Monday, February 28, 2011
Issued at HKT 15:00
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