Label Changes for:
Rotarix (Rotavirus Vaccine, Live, Oral)
Changes have been made to the WARNINGS, PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Biologics Evaluation and Research (CBER)
5 WARNINGS AND PRECAUTIONS
- In a postmarketing, observational study conducted in Mexico, cases of intussusception were observed in temporal association within 31 days following the first dose of ROTARIX, with a clustering of cases in the first 7 days. [See Adverse Reactions (6.2).]
6 ADVERSE REACTIONS
6.2 Postmarketing Experience
- The temporal association between vaccination with ROTARIX and intussusception was evaluated in a hospital-based active surveillance study thatidentified infants with intussusception at participating hospitals in Mexico. Using a self-controlled case series method, the incidence of ....
History of Intussusception
- Infants with a history of intussusception should not receive Rotarix. In postmarketing experience, intussusception resulting in death following a second dose has been reported following a history of intussusception after the first dose.
WARNINGS AND PRECAUTIONS
- Interim postmarketing safety data from a study conducted in Mexico among a birth cohort of infants suggest an increased risk of intussusception in the 31-day period following administration of the first dose of Rotarix. In this study, within the 31-day period after the first dose, most cases of intussusception occurred in the first 7 days.
- The risk of intussusception with Rotarix has been evaluated in a hospital-based Postmarketing Active Surveillance Study (PASS) in a birth cohort of infants in Mexico. An interim analysis of this study suggests an increased risk of intussusception in the 31-day period following administration of the first dose of Rotarix[Relative Risk: 1.8 (99% CI: 1.0, 3.1)]. In this study, within the 31-day period after the first dose, most cases of intussusception occurred in the first 7 days.
- Applying the relative risk observed from the interim analysis of the PASS in Mexico to estimates of background rates of intussusception in the US would approximate 0 to 4 additional cases of intussusception hospitalizations per 100,000 vaccinated infants within the 31 days after the first dose. In the first year of life, the background rate of intussusception hospitalizations in the US is approximately 34 per 100,000 infants