FDA Approves Required Revised Labeling for RotaTeq Based Final Study Results of a Mini-Sentinel Postlicensure Observational Study of Rotavirus Vaccines and Intussusception

Basic Details
Monday, July 22, 2013
Communication Type
Labeling Change
Safety Communication
FDA Center
Medical Product
rotavirus vaccine
Health Outcome(s)

The purpose of this Drug Safety Communication is to inform the public and healthcare providers that FDA is releasing final study results from a Mini-Sentinel postlicensure observational study of intussusception (a form of bowel obstruction) after vaccination with RotaTeq (Merck and Co., Inc.) and Rotarix (GlaxoSmithKline Biologicals).

RotaTeq and Rotarix are vaccines for the prevention of rotavirus gastroenteritis in infants 6 weeks to 32 weeks of age (RotaTeq) and infants 6 weeks to 24 weeks of age (Rotarix).  The study was conducted in Mini-Sentinel’s Postlicensure Rapid Immunization Safety Monitoring (PRISM) program, the largest vaccine safety surveillance program in the United States.

FDA has approved required revisions to the Prescribing Information and Patient Information for RotaTeq as a result of the new safety data from this Mini-Sentinel PRISM study.  New information was added to the Highlights, the existing intussusception subsection of the Warnings and Precautions section, and the Post-Marketing Experience section of the Full Prescribing Information, as well as to the Patient Information.  The Mini-Sentinel PRISM study is the largest study of intussusception after rotavirus vaccines to date and identified an increased risk of intussusception in the 21 day time period after the first dose of RotaTeq, with most cases occurring in the first 7 days after vaccination.  No increased risk was found after the second or third doses.  These findings translate into 1 to 1.5 additional cases of intussusception per 100,000 first doses of RotaTeq.

The data from the Mini-Sentinel PRISM study regarding the risk of intussusception following the use of Rotarix were inconclusive. Based on this study, no changes were made to the Prescribing Information or to the Patient Information for Rotarix.  However, based on data from an observational study previously conducted in Mexico, it is estimated that 1 to 3 additional cases of intussusception would occur per 100,000 vaccinated infants in the United States within 7 days following the first dose of Rotarix.  In September 2012, FDA announced that it had approved revisions to the Prescribing Information and to the Patient Information for Rotarix to include these results from the study in Mexico. Please see the FDA Update: Information on Rotarix - Labeling Revision Pertaining to Intussusception for further information.

Please see the FDA Safety Communication for further information.

Population / Cohort
Infants 5-36.9 weeks