FDA Updates Rotarix Safety Information

The U.S. Food and Drug Administration (FDA) has added information to the product label for GlaxoSmithKline’s rotavirus vaccine, which is marketed as Rotarix, after an interim analysis of a postmarketing study in Mexico indicated an increased risk of intussusception in the 31 days after the first dose of the vaccine.

MayoClinic.com defines intussusception as a serious disorder in which part of the intestine—either the small intestine or colon—slides into another part of the intestine. This “telescoping” often blocks the intestine, preventing food or fluid from passing through. Intussusception—the most common cause of intestinal obstruction in children—also cuts off the blood supply to the affected part of the intestine.

The agency said that if the risk for U.S. infants is similar to that found in the Mexico study, it would translate to as many as four additional cases of intussusception per 100,000 U.S. infants who receive the first dose of Rotarix.

Given that the relative risk for intussusception remains low and the benefits of rotavirus vaccination are great, the Centers for Disease Control and Prevention (CDC) said in a question-and-answer document for health care professionals that it continues to recommend Rotarix to prevent rotavirus disease, the most common cause of severe diarrhea among children.

Earlier this year, after the FDA learned that components of an extraneous virus (PCV1) were present in Rotarix, the agency recommended that clinicians and public health professionals in the United States temporarily suspend the use of the vaccines to prevent rotavirus disease.

The agency later revised its recommendations for rotavirus vaccines after determining that it is appropriate for clinicians and health care professionals to resume the use of Rotarix.


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