Safety Alerts & Recalls

What does this mean?

At this time, there is no evidence that the PCV1 DNA in Rotarix poses a safety risk. Because available evidence supports the safety of Rotarix, no medical follow-up is needed for patients who have been vaccinated with Rotarix.

There are two licensed vaccines for rotavirus in the United States: RotaTeq and Rotarix. For children who have received one dose of Rotarix, the CDC advises that the vaccination series can be completed with RotaTeq for the next two doses.

If you have any concerns about this alert, please follow up with your doctor or other healthcare professional.

FDA Updates Healthcare Professionals on Suspension of Use of Rotarix Vaccine

The FDA is recommending that healthcare professionals temporarily stop the use of Rotarix, a vaccine used to prevent rotavirus disease. The FDA has learned that DNA from porcine circovirus type 1 (PCV1) is present in Rotarix. PCV1 is not known to cause disease in humans. The FDA's recommendation to stop the use of Rotarix is a precaution while the agency learns more about the issue.

For more information, please visit: more information here

For specific information for patients and caregivers, please visit: more information here

Source: FDA
Publication Date: 2010-04-13
Last Updated: 2010-04-13

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