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RotaTeq Side Effects Could Lead To Intussusception Lawsuits

RotaTeg | Lawyers, Lawsuits | Side Effects: Intussusception, Intestinal Problems, Intestinal Twisting, Blockage, Intestinal Surgery

RotaTeq gained FDA approval in February 2006 and is manufactured by Merck. At the time, the FDA and Merck said trials of the vaccine involving approximately 70,000 infants indicated it did not increase the risk of intussusception. But Merck and the Centers for Disease Control and Prevention are conducting follow-up studies of tens of thousands more infants to track any long-term effects of the vaccine. The FDA is monitoring reports additionally. About 3.5 million doses of the Merck vaccine have been dispersed in the U.S., though not all have been used, the FDA said.

On February 13, 2007 the U.S. government issued a warning for a potentially life-threatening condition called Intussusception that causes the twisting of the intestines in infants vaccinated against a virus that is the leading cause of early childhood diarrhea. Intussusception originally led to the withdrawal of the first rotavirus vaccine eight years ago. The FDA said it was not know yet whether the newly approved vaccine, called RotaTeq, caused the 28 new cases.

The reports don't surpass the numbers expected to occur naturally each year, the so-called background rate, the FDA said. With this public health notification, the agency said it wanted in part to encourage reporting of any additional cases of intestinal twisting or blockage to help it assess any risks associated with the three-shot vaccine series. It also said the vaccine's label would mention the cases of intussusception. "It's a known serious, life-threatening adverse event that is being seen at an expected level post marketing. But because it is so serious, we asked the company to change the label," FDA spokeswoman Karen Riley said. The 28 cases included 16 infants who needed intestinal surgery. To date there have been no reports of deaths.

It looks like this is the natural background rate that we are seeing," said Dr. Michelle Goveia, medical director for pediatric medical affairs at the vaccine's manufacturer, Merck & Co. Inc. Goveia suggested heightened concerns about the previous vaccine, made by Wyeth, prompted the FDA to act. The earlier rotavirus vaccine, Wyeth's RotaShield, was pulled from the U.S. market in 1999 after it was linked to a small increase in intussusception. It had been on the market a year.

Legal Help For Victims Affected By RotaTeg

If your child was given the vaccine Rotateq and suffered Intussusception, please fill out the form at the right for a free case evaluation by a qualified defective drugs attorney or call us at 1-800-YOURLAWYER (1-800-968-7529).


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Study Backs Use of Rotarix, Despite Bowel Risk

Jun 17, 2011 | Parker Waichman LLP
A new study has found a slight risk of a serious bowl disorder associated with GlaxoSmithKline's rotavirus vaccine, Rotarix.  Still, authors of the Rotarix study, which was published in the New England Journal of Medicine (NEJM), say the benefits of the vaccine far exceed its risks.The study confirms that the risk of the bowel disorder - intussusception - was not limited to the RotaShield vaccine, which was pulled from the U.S. market in 1999.  According to the Food & Drug...

Pig Virus DNA Found in Merck's Rotavirus Vaccine

May 7, 2010 | Parker Waichman LLP
DNA from two types of pig virus have been detected in samples of Merck & Co.’s RotaTeq vaccine. According to The Wall Street Journal, one of the pig-virus types found in the Merck vaccine is the same one found in GlaxoSmithKline’s Rotarix vaccine in March. Both RotaTeq and Rotarix protect infants against rotavirus, which causes severe dehydration and diarrhea. It is estimated that more than 500,000 deaths in infants worldwide each year are the result of rotavirus. According to...

CDC Releases Safety Data on Rotavirus Vaccine; Reported Intussusception Cases Fall Within Expected Range

Mar 16, 2007 |
The Centers for Disease Control and Prevention (CDC) has released new safety data on a recently licensed rotavirus vaccine given to infants that indicate the vaccine does not pose an elevated risk for intussusception, the most common cause of bowel obstruction in infants. The vaccine, sold by Merck and Company under the brand name RotaTeq, was licensed by the Food and Drug Administration (FDA) in February 2006. The Advisory Committee on Immunization Practices (ACIP) recommends RotaTeq for...

State to continue using vaccine against rotavirus

Feb 15, 2007 | The Birmingham News
Alabama's Department of Public Health has dispensed more than 50,000 doses of an early childhood vaccine that is the subject of an FDA public health notification about intestinal problems in infants, an official said Wednesday. Winkler Sims, head of the state Department of Public Health's immunization division, said the state began distributing the RotaTeq vaccine in July to more than 500 sites that participate in the Children's Vaccine Program. Private providers also have been using the...

Intestinal Woes, Vaccine May Be Linked

Feb 14, 2007 | AP
The Food and Drug Administration warned yesterday of potentially life-threatening twisting of the intestines in infants vaccinated against a virus that is the leading cause of early-childhood diarrhea. The condition, called intussusception, is the same that led to the withdrawal of the first rotavirus vaccine eight years ago. The FDA said it was unknown whether the recently approved vaccine, called RotaTeq, caused the 28 new cases of the condition, which also can occur spontaneously. Indeed,...

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