RotaTeq may cause Kawasaki disease in infants, FDA warns.FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. informed health care professionals of changes to the ADVERSE REACTIONS adverse reactions, n.pl unfavorable reactions resulting from administration of a local anesthetic; responsible factors include the drug used, concentration, and route of administration. and POST-MARKETING sections of prescribing information for RotaTeq after six cases of Kawasaki disease Ka·wa·sa·ki disease n. See mucocutaneous lymph node syndrome. Kawasaki disease Mucocutaneous lymph node syndromeA disease of children < age 5 that often follows a 1-2 wk prodrome Etiology Uncertain; bugs implicated were observed during the Phase III clinical trial Noun 1. phase III clinical trial - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the . There were five cases among the 36,150 infants who received RotaTeq and one case among the 35,536 infants who received placebo. The POST-MARKETING section of the prescribing information was revised to reflect three reports of Kawasaki disease to the Vaccine Adverse Event Reporting System The Vaccine Adverse Event Reporting System is a United States program for vaccine safety, co-sponsored by the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA). (VAERS VAERS Vaccine Adverse Event Reporting System (lists hospitalizations or deaths resulting from vaccinations) ) since licensure on Feb. 3, 2006. There is not a known cause and effect relationship between receiving RotaTeq, or any vaccine and the occurrence of Kawasaki disease. Kawasaki disease is a serious but uncommon illness in children that is poorly understood and whose cause has not been determined. It is characterized by high fever and inflammation of the blood vessels and affects the lymph nodes, skin, mouth and heart. The cases reported to date are not more frequent than what could be expected to occur by coincidence. FDA and the Centers for Disease Control will continue to monitor the safety of RotaTeq and all vaccines and encourage that all severe adverse events, including any additional cases of Kawasaki disease after administration of RotaTeq, as well as other vaccines, be reported to VAERS. Read the complete MedWatch 2007 Safety Summary, including a link to the FDA Information Page and Company's revised prescribing information for RotaTeq regarding this issue at: http://www.fda.gov/medwatch/safety/2007/safety 07.htm#RotaTeq2 |
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