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Offit's RotaTeq Safety Labeling Updated to Include Cases of Kawasaki Disease

Posted Sep 12 2008 11:30am
Paul Offit, who believes that it is safe to inject babies with more than "100,000" vaccines at once (I emailed him to make sure he was not being misquoted, and he replied, "The figure of 100,000 is correct, and probably a little conservative."), has his vaccine labeling changed to note that it may cause Kawasaki Disease.

RotaTeq Safety Labeling Updated to Include Cases of Kawasaki Disease
http://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@cber.fda.gov.


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