There have been 28 cases of dangerous twisting of the intestines (intussusception) in infants who received a newly-approved vaccine against rotavirus, the US Food and Drug Administration said Tuesday.
In 16 of those 28 cases, infants required intestinal surgery. There were no deaths.
However, the FDA said it wasn't clear whether the vaccine, RotaTeq, actually caused the 28 cases of intussusception, which can occur naturally, the Associated Press reported. In fact, the reported cases don't exceed the number expected to occur naturally each year in the US, the agency said.
The FDA said it issued the public health notification in part to encourage reporting of any additional cases of intussusception in order to help the agency assess any risks associated with RotaTeq, which was approved by the FDA in February 2006.
The agency asked drug maker Merck & Co. to change the labelling on RotaTeq to mention the cases of intussusception, the AP reported.
A previous rotavirus vaccine, Wyeth's RotaShield, was taken off the market eight years ago after it was linked to intussuception. The rotavirus is the leading cause of diarrhoea in early childhood.Fewer cases than expected
RotaTeq co-inventor Dr Paul Offit, of the Children's Hospital of Philadelphia, said the 28 reported cases were well below the hundreds that would be expected to occur naturally.
"I am actually encouraged by those data: 28 cases, when you would have expected at least 500 cases - that is really reassuring," he told the AP. "I don't see how those numbers suggest something's gone awry. If anything, they suggest nothing's awry." – (HealthDayNews)