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Rotarix Warnings and Precautions

Specific Rotarix Warnings and Precautions

Warnings and precautions to be aware of prior to taking Rotarix include the following:
 
  • A previously marketed rotavirus vaccine (RotaShield®) was taken off the market due to the risk of a serious intestinal side effect known as intussusception (when one portion of the bowel slides over the other, creating a blockage).

Preliminary results from a study in Mexico indicate there may be an increased risk of intussusceptions in the first 31 days after the first dose of Rotarix. Most of these cases occurred within the first 7 days of the 31-day period. It is important to seek immediate medical attention if your child develops symptoms of this problem, such as:

    • Intense abdominal pain (stomach pain)
    • Inconsolable shrieking
    • Bringing the knees to the chest
    • Bright-red "currant jelly" stool
    • Vomiting of green bile.

 

  • Rotarix was not adequately studied in children with blood disorders (such as leukemia) or immune-suppressing conditions, nor has it been studied in children who take immune-suppressing medications (see Rotarix Drug Interactions). It is unknown if Rotarix is safe and effective for such children.
     
  • Rotarix is a live virus vaccine and can potentially cause a rotavirus infection, particularly in children with weakened immune systems.
     
  • Occasionally, children who have been vaccinated may shed the virus in the stool and could potentially transmit it to others. If your child has close contacts (friends and relatives) with weakened immune systems, be sure to ask your child's healthcare provider if postponing (or not giving) the vaccine would be a good idea.
     
  • Very rare cases of Kawasaki disease have also been reported (too rare to know if there is any link to the vaccine). This disorder can be life-threatening if left untreated. Signs of Kawasaki disease include:

 

    • Fever
    • Rash
    • Red mouth and eyes
    • Swollen hands and feet
    • Swollen glands.

 

  • It is unknown if Rotarix is safe or effective in children who have current digestive illnesses, chronic diarrhea, failure to thrive (poor weight gain), or a history of abdominal surgery or intussusception.

 

  • Parents who are concerned about exposing their children to thimerosal can be confident that this vaccine contains no thimerosal (a mercury-containing preservative), not even in trace amounts. Some parents are concerned about aluminum content of vaccines; this vaccine contains no aluminum.
     
  • This vaccine is not made from human fetal components, as some vaccines are. It is, however, grown on a line of monkey kidney cells.

 

  • Your child can receive Rotarix if he or she has a mild illness (such as the common cold). However, it is usually best to postpone the vaccine in the case of a moderate or severe illness.
     
  • Make sure the healthcare provider knows if your child has ever had any serious reactions to any vaccines in the past.
     
  • Rotarix is considered a pregnancy Category C medication. This means it is unknown if it is safe for use during pregnancy. However, this is a childhood vaccine and should not be given to pregnant women.
     
  • At this time, it is unknown if Rotarix passes through breast milk. However, this is a childhood vaccine and should not be given to breastfeeding women.
     
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