February 2007 FDA Intussusception Warning

In 1999, the rotavirus vaccine RotaShield was pulled from the market after being linked to an increase in intussusception in infants. Intussusception is a dangerous twisting of the intestines that can often require intestinal surgery. On February 13, 2007, the government issued a warning that there have been 28 new cases of intussusception recently reported. It is not known if the new rotavirus vaccine RotaTeq may be the cause of this.

The rotavirus causes diarrhea in children and newborns. In the United States, it has infected over 2.7 million children under five years of age. Of these children, 70,000 were hospitalized, with a range of 20 to 70 deaths each year caused by the rotavirus.

RotaTeq was approved by the FDA in 2006 as a new vaccination series against the rotavirus. Tests indicated there were no increases in intussusception in the 70,000 children that were followed after receiving the injection series. Follow-up studies are continuing on these children to determine if there are long term side effects from RotaTeq.

The FDA has noted that the current 28 new cases do not exceed the natural instances of intussusception expected yearly. Dr. Michelle Goveia, the medical director for pediatric medical affairs of Merck & Co. Inc. has stated these numbers indicated a natural background rate for intussusception.

Karen Riley, an FDA spokeswoman, backs this possibility, stating, “It’s a known serious, life-threatening adverse event that is being seen at an expected level of post-marketing.” She continued, “But because it is so serious, we asked the company to change the label.” The FDA is asking Merck to mention these cases of intussusception on the label of RotaTeq. This will encourage further possible cases to be reported, giving both the FDA and Merck more information to study regarding any new intussusception cases.

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