RotaTeq Safety Labeling Updated to Include Cases of Kawasaki Disease.

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RotaTeq Safety Labeling Updated to Include Cases of Kawasaki Diseasehttp://www.medscape.com/viewarticle/558530?src=mp Yael Waknine Medscape Medical News 2007. © 2007 Medscape June 19, 2007 — Changes have been made to the adverse reactions and postmarketing sections of the safety labeling for a live, oral, pentavalent rotavirus vaccine (RotaTeq, Merck and Company, Inc); it now includes cases of Kawasaki disease, the US Food and Drug Administration (FDA) told healthcare professionals on Friday. The poorly understood disease is uncommon in children, is characterized by high fever and blood vessel inflammation, and affects the lymph

nodes, skin, mouth, and heart. During a phase 3 clinical trial, 5 cases of Kawasaki disease were reported among 36,150 infants who received the vaccine, compared with only 1 case among 35,536 who were given placebo, according to an alert sent from MedWatch, the FDA's safety information and adverse event reporting program. Three other cases have been reported through the Vaccine Adverse Event Reporting System (VAERS) since the vaccine was approved on February 3, 2006. There is no known cause-and-effect relationship between the use of this or any other vaccine and Kawasaki disease, the FDA said, noting that the cases reported to date are not more frequent than what would be expected to occur by coincidence. Rotavirus vaccine is indicated for the prevention of rotavirus gastroenteritis in infants and children, which is caused by the serotypes G1, G2, G3, and G4, when

administered orally as a 3-dose series to infants between the ages of 6 and 32 weeks. Healthcare professionals are encouraged to report cases of Kawasaki disease and other adverse events potentially associated with the vaccine to VAERS by going online at www.vaers.hhs.gov or calling 1-800-822-7967 for a report form. Additional information about the use of the vaccine can be obtained by contacting the FDA’s Center for Biologics Evaluation and Research at 1-800-835-4709 or by e-mail at octma. "A single vaccine given to a

six-pound newborn is the equivalent of giving a 180-pound adult 30 vaccinations on the same day. Include in this the toxic effects of high levels of aluminium and formaldehyde contained in some vaccines, and the synergist toxicity could be increased to unknown levels. Additionally, mercury is a well-known inhibitor of kidney function."--Boyd Haley Ph.D.

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