The FDA has notified physicians and parents of potentially life-threatening twisting of the intestines (intussusception) in infants who received Merck’s vaccine, RotaTeq, to protect against a virus that is the leading cause of early childhood diarrhea.
Rotavirus affects millions of children worldwide, mostly in developing countries. In the U.S., the virus is responsible for more than 400,000 doctor’s visits and as many as 60 deaths.
The FDA said that the RotaTeq label would mention the possibility of intussusception. canadian pharmacy viagra
It is unknown whether the vaccine, approved last year, caused the 28 new cases. Some of the infants needed intestinal surgery. There have been no reports of deaths.
Eight years ago, Wyeth withdrew its own rotavirus vaccine because of similar reports of intestinal blockage.