RotaShield Withdrawn by American Home Products
May 21, 2001
The three-dose oral vaccine RotaShield, manufactured by a division of American Home Products, was removed from the market after questions of infant safety were raised. The Food and Drug Administration approved RotaShield in 1998 to help infants avoid rotavirus. Between 1998 and July 2000 the FDA received fifteen reports of RotaShield related bowel obstructions. This condition, known as intussusception, occurs when one part of the intestine folds into itself. Intussusception can cause vomiting, abdominal pain, and bloody stools. Some of the infants diagnosed with intussusception required surgery.
Since the removal of RotaShield, a total of 100 cases of intussusception have been documented. In almost all these cases, the infant developed intussusception within two to three weeks after RotaShield was administered. As such, medical professionals believe that there is no ongoing threat posed by RotaShield.
RotaShield was developed by American Home Products and Wyeth-Lederle Vaccines. In the United States alone, over 55,000 infants a year are infected with rotavirus, sometimes requiring hospitalization.
-- Article Courtesy of InjuryBoard.com
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