O FDA informou os profissionais da saúde de mudanças nas informações de prescrição do produto RotaTeq®. A secção de Reações Adversas foi atualizada para incluir 6 casos de doença de Kawasaki que foram observadas durante ensaio clínico de Fase 3. Ocorreram 5 casos entre 36.150 crianças que receberam TotaTeq® e um caso entre 36.536 crianças que receberam placebo. A secção Pós-Marketing foi revisada para incluir 3 casos de doença de Kawasaki relatados ao Vaccine Adverse Event Reporting System (VAERS), desde o seu licenciamento em 03 de Fevereiro de 2006. Não há um relacionamento de causa e efeito conhecido entre a administração de RotaTeq®, ou qualquer vacina e a ocorrência de doença de Kawasaki.
A doença de Kawasaki é uma enfermidade séria, mas incomum em crianças, que é muito pouco compreendida e sem causa determinada pertencente ao grupo das vasculites. Caracteriza-se por febre elevada e inflamação dos vasos sanguíneos afetando os nódulos linfáticos, pele, boca e coração. Os casos relatados até o momento não são mais freqüentes do que poderia se esperar apenas por coincidência. O FDA e o CDC continuarão a monitorizar e encorajar que todos os eventos adversos severos, incluindo qualquer caso adicional de doença de Kawasaki após administração de RotaTeq, assim como outras vacinas, sejam relatados ao VAERS.
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[url=http://my.curse.com/members/LILLIANA1.aspx]STEPHANIE SEYMOUR NUDE[/url]
STEPHANIE SEYMOUR NUDE
[url= http://my.curse.com/members/LILLIANA1.aspx ] STEPHANIE SEYMOUR NUDE [/url]
HELENA CHRISTENSEN NUDE
[url=http://my.curse.com/members/LINDSEY4.aspx]HELENA CHRISTENSEN NUDE[/url]
HELENA CHRISTENSEN NUDE
[url= http://my.curse.com/members/LINDSEY4.aspx ] HELENA CHRISTENSEN NUDE [/url]
BIJOU PHILLIPS NUDE
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BIJOU PHILLIPS NUDE
[url= http://my.curse.com/members/LINETTE6.aspx ] BIJOU PHILLIPS NUDE [/url]
MACKENZIE ROSMAN NUDE
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MACKENZIE ROSMAN NUDE
[url= http://my.curse.com/members/LINNEA2.aspx ] MACKENZIE ROSMAN NUDE [/url]
BRYCE DALLAS HOWARD NUDE
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BRYCE DALLAS HOWARD NUDE
[url= http://my.curse.com/members/LIZZIE1.aspx ] BRYCE DALLAS HOWARD NUDE [/url]
DAISY FUENTES NUDE
[url=http://my.curse.com/members/LONNIE2.aspx]DAISY FUENTES NUDE[/url]
DAISY FUENTES NUDE
[url= http://my.curse.com/members/LONNIE2.aspx ] DAISY FUENTES NUDE [/url]
DANNII MINOGUE NUDE
[url=http://my.curse.com/members/LORAINE1.aspx]DANNII MINOGUE NUDE[/url]
DANNII MINOGUE NUDE
[url= http://my.curse.com/members/LORAINE1.aspx ] DANNII MINOGUE NUDE [/url]
DANNEEL HARRIS NUDE
[url=http://my.curse.com/members/LOREAN1.aspx]DANNEEL HARRIS NUDE[/url]
DANNEEL HARRIS NUDE
[url= http://my.curse.com/members/LOREAN1.aspx ] DANNEEL HARRIS NUDE [/url]
ANGIE HARMON NUDE
[url=http://my.curse.com/members/LOREEN2.aspx]ANGIE HARMON NUDE[/url]
ANGIE HARMON NUDE
[url= http://my.curse.com/members/LOREEN2.aspx ] ANGIE HARMON NUDE [/url]
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