Label Changes for RotaTeq

Jamie Sheller

Attorney
(866) 735-1102 Ext 475

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Health care professionals were recently alerted to RotaTeq label changes. RotaTeq is a vaccine given to infants to prevent illness from the rotavirus. The ADVERSE REACTIONS and POST-MARKETING sections of the RotaTeq prescribing information were changed to reflect cases of Kawasaki disease. Kawasaki disease has not been shown to be caused by RotaTeq or any vaccine. Typically, Kawasaki disease affects children less than 5 years old. Some symptoms include a fever of 104 degrees, lasting 5 days or more, red, cracked and dry lips, a rash on the stomach, chest and genitals, swollen lymph nodes and a swollen tongue with a white coating and big red bumps. Untreated Kawasaki disease can lead to complications involving the heart.

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