• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Safety

  • Print
  • Share
  • E-mail

Rotavirus, Live, Oral, Pentavalent vaccine (RotaTeq) February 2007

Audience: Pediatric healthcare professionals, consumers

[Posted 02/13/2007] FDA issued a Public Health Notification to inform health care providers and consumers about 28 post-marketing reports of intussusception following administration of Rotavirus, Live, Oral, Pentavalent vaccine (RotaTeq). Intussusception is a serious and potentially life-threatening condition that occurs when the intestine gets blocked or twisted.

Because vaccine adverse events are not always reported to FDA, there may be additional cases of intussusception following vaccination of which we are unaware. This information is important in helping FDA and CDC assess whether RotaTeq may be associated with an increased risk of intussusception and, if so, to what degree. Healthcare professionals and others are encouraged to report any cases of intussusception or other serious events that may be associated with the use of RotaTeq to the Vaccine Adverse Event Reporting System (VAERS). Parents should contact their child’s doctor immediately if the child has stomach pain, vomiting, diarrhea, blood in their stool or change in their bowel movements, as these may be signs of intussusception.

[February 13, 2007 – Public Health Notification – FDA]
[January 2007 – Label – Merck]
[January 2007 – Patient Product Information – Merck]