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RotaTeq FDA Alerts

The FDA Alert(s) below may be specifically about RotaTeq or relate to a group or class of drugs which include RotaTeq (rotavirus vaccine).

MedWatch Safety Alerts are distributed by the FDA and published by Following is a list of possible medication recalls, market withdrawals, alerts and warnings. For the latest FDA MedWatch alerts, go here.

Recent FDA Alert(s) for rotavirus vaccine

Rotarix Vaccine: Update to Clinicians and Public Health Professionals

May 16, 2010

Audience: Pediatric and family practice healthcare professionals, public health professionals

[UPDATED 05/16/2010] FDA has determined it is appropriate for clinicians and health care professionals to resume the use of Rotarix and to continue the use of RotaTeq. Based on a careful evaluation of laboratory results from the manufacturers and its own laboratories, a thorough review of the scientific literature, and input from scientific and public health experts, the agency is revising its recommendation to temporarily suspend use of the Rotarix vaccine. FDA has also determined that RotaTeq vaccine should remain in use. 

In its decision, FDA considered that both vaccines have strong safety records, including clinical trials involving tens of thousands of patients as well as clinical experience with millions of recipients. FDA has no evidence that either porcine circovirus (PCV1 or PCV2) poses a safety risk in humans, and notes that neither is known to cause infection or illness in humans. The benefits of the vaccines are substantial, and include prevention of hospitalization for severe rotavirus disease in the United States and of death in other parts of the world.  he benefits outweigh the risk, which is theoretical. FDA and the manufacturers will continue to investigate the findings of PCV in rotavirus vaccines and will evaluate information from ongoing testing by FDA and the manufacturers.


[Posted 03/22/2010] FDA is recommending that healthcare professionals temporarily suspend the use of Rotarix, a vaccine used to prevent rotavirus disease. FDA's recommendation is a precaution taken while the agency learns more about the situation.

FDA has learned that DNA from porcine circovirus type 1 (PCV1) is present in Rotarix. PCV1 is not known to cause disease in humans. There is no evidence at this time that this finding 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, CDC advises that clinicians can complete the series with RotaTeq for the next two doses.

Rotavirus, Live, Oral, Pentavalent vaccine (RotaTeq) - June 15, 2007

Jun 15, 2007

Audience: Pediatric healthcare professionals, consumers

[Posted 06/15/2007] FDA informed healthcare professionals of changes to the ADVERSE REACTIONS and POST-MARKETING sections of the product's prescribing information. The ADVERSE REACTIONS section was updated to include six cases of Kawasaki disease that were observed during the Phase 3 clinical trial. There were five cases among the 36,150 infants who received RotaTeq and one case among the 35,536 infants who received placebo. The POST-MARKETING section of the prescribing information was revised to reflect three reports of Kawasaki disease to the Vaccine Adverse Event Reporting System (VAERS) since licensure on February 3, 2006. There is not a known cause and effect relationship between receiving RotaTeq, or any vaccine and the occurrence of Kawasaki disease.

Kawasaki disease is a serious, but uncommon illness in children that is poorly understood and the cause has not been determined. It is characterized by high fever and inflammation of the blood vessels and affects the lymph nodes, skin, mouth and heart. The cases reported to date are not more frequent than what could be expected to occur by coincidence. FDA and the Centers for Disease Control and Prevention will continue to monitor the safety of RotaTeq and all vaccines and encourage that all severe adverse events, including any additional cases of Kawasaki disease after administration of RotaTeq, as well as other vaccines, be reported to VAERS.

[June 15, 2007 - Information Page - FDA]

Rotavirus, Live, Oral, Pentavalent vaccine (RotaTeq) - Feb 13, 2007

Feb 13, 2007

Audience: Pediatric healthcare professionals, consumers

[Posted 02/13/2007] FDA issued a Public Health Notification to inform health care providers and consumers about 28 post-marketing reports of intussusception following administration of Rotavirus, Live, Oral, Pentavalent vaccine (RotaTeq). Intussusception is a serious and potentially life-threatening condition that occurs when the intestine gets blocked or twisted.

Because vaccine adverse events are not always reported to FDA, there may be additional cases of intussusception following vaccination of which we are unaware. This information is important in helping FDA and CDC assess whether RotaTeq may be associated with an increased risk of intussusception and, if so, to what degree. Healthcare professionals and others are encouraged to report any cases of intussusception or other serious events that may be associated with the use of RotaTeq to the Vaccine Adverse Event Reporting System (VAERS). Parents should contact their child’s doctor immediately if the child has stomach pain, vomiting, diarrhea, blood in their stool or change in their bowel movements, as these may be signs of intussusception.

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