FDA Updates RotaTeq Label

The FDA has added information about Kawasaki disease to the label for the rotavirus vaccine (RotaTeq), but has not issued new warnings or precautions about the vaccine's use and maintains that it is safe.

The updated label includes information about six cases of Kawasaki disease that occurred during the drug's clinical trials and three cases reported since the vaccine was licensed in February 2006. The number of cases reported is no greater than the number that would be expected by chance. There is no known cause-and-effect relationship between the vaccine and the disease.

The FDA will monitor for additional cases of Kawasaki disease, but says that the vaccine is safe and effective and the "best way to protect a child against rotavirus disease."

Source: Physician's First Watch June 18th 2007

Detailed FDA report: http://www.fda.gov/cber/label/rotateqLBinfo.htm