Rotavirus Vaccine Linked To Bowel Problems

Not for the first time, a study has linked the <"">rotavirus vaccination with bowel issues. The vaccine prevents the most prevalent causes of serious diarrhea and dehydration in infants, but can also lead to a possibly life threatening bowel illness, said WebMD.

The study involved US Centers for Disease Control and Prevention (CDC) investigators and Latin American health agencies. The groups discovered that between 1 in 51,000 and 1 in 68,000 babies given the Rotarix, a rotavirus vaccine, made by GlaxoSmithKline, could develop intussusception, said WebMD.

Intussusception is a serious and potentially life-threatening condition that occurs when the intestine gets blocked or twisted. Intestinal obstruction occurs when one portion telescopes into a nearby portion. The most common site is where the small intestine joins the large intestine. Because the two walls of the intestines press against each other, this causes inflammation, swelling, and eventually decreased blood flow. If not detected early, internal bleeding, a hole in the intestines, and infection in the abdomen, may occur due to the intestinal tissue dying from the decreased blood flow.

Rotavirus disease is the leading cause of severe diarrhea and dehydration in young infants worldwide. Prior to rotavirus vaccines becoming available, most children in the US were infected with rotavirus before the age of two resulting in 55,000-70,000 hospitalizations and 20-60 infant deaths annually. Today, rotavirus disease is estimated to be responsible for the deaths of more than 500,000 infants around the world yearly, primarily in poorer countries.

Rotarix was approved for use in the US in 2008. Babies receive the vaccination at two and four months of age to protect from rotavirus disease. According to the CDC, as of June 2009, about 72 percent of US infants five months of age had received at least one dose of rotavirus vaccine.

Wyeth Lab’s RotaShield rotavirus vaccine was withdrawn from the US market in 1999 not even one year after it was introduced, said WebMD, which noted that, in 1999, the US Food and Drug Administration (FDA) said that RotaShield caused intussusception in 1 of every 10,000 babies who were vaccinated with the drug.

This new study also confirmed that the risk of bowel obstruction was not limited to RotaShied, Umesh D. Parashar, MD, of the CDC’s National Center for Immunization and Respiratory Diseases, told WebMD. If the risk of intussusception in the US turns out to be the same as that in Latin America, said Parashar, MD, then it is likely the cause of 50-60 intussusception cases annually around the world, wrote WebMD.

Merck’s RotaTeq is the only other rotavirus vaccination approved for use in the US; RotaTeq was not used in the Latin American group involved in this study; however, said WebMD, Australian researchers have reported a risk with the vaccine, according to Stanford University professor of microbiology and immunology Harry Greenberg, MD, wrote in an editorial published with the study. Both studies appear in the June 16 issue of The New England Journal of Medicine.

Last year, we wrote that the FDA announced that initial results from a Mexican study with Rotarix suggested an increased risk of intussusception, especially during the 31 days following the first Rotarix dose, with most in the first seven days. At the time, the FDA noted those results were included to the product’s label.

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