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FDA ISSUES AN ALERT REGARDING CASES OF INTUSSUSCEPTION IN INFANTS
 
February 13, 2006 FDA issues an alert regarding cases of intussusception in infants vaccinated with RotaTeq® (rotavirus) vaccine.

Intussusception is a disorder in which one part of the intestine, usually the small intestine, slides inside another part. This is sometimes referred to as "telescoping" because it's similar to the way a collapsible telescope folds together. Intussusception is much more common in children, particularly in infants younger than 1 year, than in adults.

For most cases of intussusception in children, the cause is unknown; it occurs spontaneously. Or it may be triggered by a viral infection or a growth in the intestine, such as a polyp, lymph node or tumor. In the past, some cases of intussusception seemed to be associated with a version of the rotavirus vaccine (RotaShield). That vaccine was removed from the market in 1999.

The alert states it is unknown if the vaccine caused the 28 new cases. FDA issued the notification to encourage reporting of any additional cases of intussusception to help assess if there is association with the newly licensed rotavirus vaccine RotaTeq®.

Summary:

  1. Rotavirus is not an innocuous illness;
  2. It is unknown if the vaccine caused the 28 new cases.
  3. The notice does not mean there is a problem with the RotaTeq® vaccine. CDC continues to support the Advisory Committee on Immunization Practices' recommendation for routine immunization of all U.S. infants with three doses of RotaTeq® administered orally at ages 2, 4 and 6 months.

See complete FDA RotaTeq® notification at:

http://www.fda.gov/cber/safety/phnrota021307.htm

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