RotaTeq contains up to five strains of rotavirus, an infection that can affect the digestive system in young children and infants. It is used to prevent this disease in children—a disease that can cause severe stomach and intestinal illness. RotaTeq will not treat the disease if it is active in the child, but works by exposing the patient to a small dose of the infection, building up the patient’s immunity to the virus. It is administered to children from 6 weeks to 32 weeks old. The drug was manufactured by Merck and was approved by the FDA in 2006.

In 2007, the FDA issued a warning about RotaTeq stating that the drug had been linked to a life-threatening condition called intussusception—a twisting of the intestines that is the leading cause of infant diarrhea. 28 cases of intussusception were reported to the FDA, including 16 infants that required surgery. Intussusception can occur naturally in infants, and some professionals are still unsure as to whether these cases were cause by the drug or if they were just natural occurrences.

Serious side effects may include:

  • Seizure (black-out or convulsions)
  • Severe or ongoing diarrhea
  • Dark red stools
  • Fever, chills, cough with yellow or green mucus
  • Stabbing chest pain, chest tightness, wheezing, feeling short of breath
  • Stomach pain, weakness, loss of appetite, vomiting
  • Ear pain, swelling, or drainage
  • Runny or stuffy nose, sore throat
  • Pain or burning when you urinate
  • High fever, redness of the skin or eyes, swollen hands, peeling, skin rash, chapped or cracked lips

Other less serious side effects may include crying or mild irritability.

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