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This week, the U.S. Food and Drug Administration alerted doctors and patients of a possibly fatal bowel condition seen in some infants who received Merck & Co.'s RotaTeq, a new vaccine against a virus that causes severe diarrhea and is one of the leading causes of hospitalization for newborns.

Since the vaccine's FDA approval in February 2006, almost 3.5 million babies and young children in the United States have received RotaTeq.

Life-Threatening Bowel Condition

The FDA warning against RotaTeq came after reports of 28 cases of intussusception, a potentially deadly bowel condition characterized by severe abdominal pain.

Most babies will fully recover if treated within the first 24 hours of developing intussusception. But, delayed treatment could lead to serious complications and risks, including punctures in the bowel, tissue damage, and death.

So far, there have been no death reports. But 16 of the 28 babies needed surgical treatment.

The warning label on the vaccine has been updated by Merck to include the risk of serious adverse events including hematochezia—intestinal bleeding—and intussusception. This same condition caused the first rotavirus vaccine to be recalled from the market in 1999.

The FDA encourages all doctors and consumers to report any more cases of intestinal problems including blockage and twisting to assess the risks linked to RotaTeq.

Has your child suffered injury because of a defective drug? You may be eligible to recover your losses. Please click here to consult with an experienced and compassionate product liability lawyer about your legal rights and options.