Click Here to View the Today Show segment on HPV Vaccine
"The FDA's public health notification about the intussusception cases includes these recommendations: "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. It is important to contact the child's doctor if there are any questions or if the child has any of these symptoms at any time after vaccination, even if it has been several weeks since the last vaccine dose." The FDA also asks that any cases of intussusception be reported to the Vaccine Adverse Event Reporting System (VAERS), which is run by the FDA and CDC." - Miranda Hitti, WebMd Medical News
Barbara Loe Fisher Commentary:
Yesterday, (2/13/07) I appeared on NBC's "The Today Show," where I debated NBC resident doctor Nancy Snyderman, M.D. and Texas legislator Jessica Farrar, who introduced a bill in Texas to require sixth grade girls to get HPV vaccine. This debate was a follow-up to the Feb. 5 debate between Rep. Farrar and PROVE president Dawn Richardson, which generated so much email and letters to NBC that they decided to follow-up. This was my fourth debate with physicians on the "Today Show" in the past 15 years, the last one being a decade ago with Johns Hopkin's Neal Halsey, M.D.
NBC was the network which broke the story, in 1982, about vaccine risks. Lea Thompson, a mother and consumer reporter for the NBC affiliate in Washington, D.C., produced an Emmy award winning documentary "DPT: Vaccine Roulette." That show served as the foundation for the vaccine safety and informed consent movement, which parents launched with the founding of a parent-led organization now known as the National Vaccine Information Center. The medical literature NBC reporter Thompson used to document DPT vaccine risks served as my foundation for co-authoring the book DPT: A Shot in the Dark published by Harcourt Brace Jovanovich in 1985. NBC deserves credit for allowing live debates to take place about vaccine safety over the years so the public can be better informed about the subject of vaccination.
After the "Today Show" ended yesterday and before I flew back to Washington, D.C., I ran into Merck's Rotateq vaccine co-patent holder, Paul Offit, M.D. in the lobby of another studio. I wonder if he knew that, by the end of the day, the FDA would issue a warning to parents to be on the lookout for their babies bowels collapsing after getting injected with the diarrhea vaccine he and other interested parties persuaded the CDC to recommend for use by all babies.
The FDA is asking doctors and parents to report cases of bowel blockage (intussusception) that babies suffer after getting Rotateq to the federal Vaccine Adverse Event Reporting System(VAERS). The FDA should also be asking doctors and parents to report all serious health problems after little girls get injected with Merck's HPV Vaccine, GARDASIL.
Serious Bowel Problems Reported in 28 U.S. Babies After Getting RotaTeq Vaccine
WebMD Medical News
Published: February 13, 2007
by Miranda Hitti
Feb. 13, 2007 -- The FDA today announced that 28 U.S. babies reportedly developed a potentially deadly bowel problem after getting the RotaTeq vaccine. The babies developed intussusception, a serious and potentially life-threatening condition in which the intestine gets blocked or twisted.
Sixteen of the 28 babies required hospitalization and surgery. The other 12 needed enemas to reduce the intussusception. None died.
RotaTeq targets rotavirus, a leading cause of kids' diarrhea. The vaccine, approved by the FDA last year, is on the CDC's 2007 recommended child immunization schedule. It's given in three doses when babies are 2 to 6 months old.
It's not known whether RotaTeq caused the babies' intussusception. The number of reported cases is in line with expectations, says the FDA.
However, a different rotavirus vaccine, called RotaShield, was withdrawn from the market in 1999 after a rise in intussusception was noted after its use.
RotaTeq's label has been updated to reflect the intusssusception reports. But the vaccine's "dosage and administration schedule remains unchanged," says the FDA.
The FDA's Recommendations
The FDA's public health notification about the intussusception cases includes these recommendations:
"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. It is important to contact the child's doctor if there are any questions or if the child has any of these symptoms at any time after vaccination, even if it has been several weeks since the last vaccine dose."
The FDA also asks that any cases of intussusception be reported to the Vaccine Adverse Event Reporting System (VAERS), which is run by the FDA and CDC.
For a copy of the vaccine reporting form, call 800- 822-7967 or go online to www.vaers.hhs.gov.
Reported Cases
The 28 cases of intussusception were reported between the FDA's approval of RotaTeq on Feb. 3, 2006 and Jan. 31, 2007.
RotaTeq's intussusception risk was studied in approximately 70,000 infants -- half of whom got the RotaTeq vaccine; the other half got a placebo -- before the FDA approved RotaTeq.
Those studies showed "no significant increased risk of intussusception," notes an FDA public health notice.
The FDA also says that "the number of intussusception cases reported to date after RotaTeq administration does not exceed the number expected," based on unpublished CDC data.
According to the FDA, about 3.5 million doses of RotaTeq had been distributed in the U.S. through Feb. 1, 2007, but not all of those doses have been administered.
The 28 intussusception cases were reported after the first, second, and third doses of the vaccine. The cases occurred within 73 days after getting any of those doses; roughly half of the cases happened within 21 days.
The FDA's Past Comments
When the FDA approved RotaTeq just over a year ago, the FDA's Jesse Goodman, MD, MPH, called data from the vaccine's preapproval studies "reassuring."
But Goodman, who directs the FDA's Center for Biologics Evaluation and Research, also said at the time that "people would need to consider that [the studies] are not conclusive that this side effect could not potentially occur" and that the FDA had put in place "an extremely aggressive program to try to get as much information about the vaccine in its early period of use as possible."
Further studies are being done to probe the risk of intussusception and other serious events with RotaTeq.
RotaTeq's maker, the drug company Merck, is conducting a postmarketing study of approximately 44,000 infants. The CDC is doing its own study of about 90,000 infants, says the FDA. Merck is a WebMD sponsor.
Merck's Comments
WebMD contacted Merck for the company's comments.
In a news release emailed to WebMD, Merck states that intussusception is "a naturally occurring event in infants" that is estimated to occur in approximately one in 2,000 infants during the first year of life.
"Cases of intussusception can occur when no vaccine has been given, and the cause is usually unknown," Merck states.
The news release also includes comments from Mark Feinberg, MD, PhD, vice president of policy, public health, and medical affairs for Merck Vaccines.
"It is common for post-marketing experience information with a vaccine to be reported to VAERS and for the prescribing information to be updated accordingly," Feinberg says, in the news release.
Feinberg says public health and patient safety are Merck's "highest priorities" and that Merck is "very confident" in the data supporting RotaTeq's safety profile from its preapproval study.
RotaShield, the vaccine that was withdrawn from the market in 1999, was made by the drug company Wyeth.
Wyeth is a WebMD sponsor.
10 comments:
I Saw you on the Today Show, and was very happy to hear you speak, albeit the little time they alotted you since Nancy Sneiderman Dominated the Segment. I am interested in helping anyway I can with your Organization. Parents need to learn their rights when it comes to the Medical Profession and Government. Please email me: noelle@lnoelle.com
Thanks for your work Barbara and thanks for being willing to go up against what was clearly a stacked deck on the NBC show. One thing I noticed that was clearly incorrect was the statement that HPV might be eradicated if enough people took the vaccine. But it was clearly stated at the beginning of the segment that the vaccine would only prevent cancer and would not stop the virus itself.
By the way. A very important point that you brought up on The Today Show was that Our Vaccinated Children Our Sick, Sicker than they've ever been, and everyone seems to think this has nothing to do with Vaccines? My 2 children who have never been vaccinated, are the only ones in their classes who have never needed antibiotics or ever had an ear infection. In fact neither one has even had a high fever! My oldest is almost 8 and my youngest is 2-1/2. The healthiest kids I know are NON-Vaccinated children. Until they figure out what is happening amongst our school aged children, with epidemic health issues, the last thing anyone should be doing is adding more vaccines to an already over loaded, outrageous schedule!
I almost lost a 5 month old perfectly healthy grandson to the Rotateq vaccine just this past weekend. Thanks to the Pediatric Transport Team from Cabell-Huntington Hospital in Huntington, WV, as well as the quick actions of the staff at Cabell-Huntington Hospital, my grandson survived. I think he is the 29th reported case of intusesseption. The FDA needs to issue stronger warnings and make the public more aware of the specific complications of this vaccine.
My 5 month old son was hospitalized for bloody stools 7 days after Rotateq vaccine. When I brought this up to the Doc I was told that he would be in pain and was dismissed calling the incident a possible "milk protein allergy". I breastfeed exclusively and that is a rare occurence. I continued to nurse without restrictions and my son is fine. A protein allergy would not resolve itself that quickly if it were severe enough to cause that much blood. Where is the loyalty to our children? All of the uneccesary testing and expense etc..,what a nightmare! I don't know who to trust now!!
My 2 1/2 month old daughter was just at the doctor for blood in her stool. She is exclusively breastfed, and for all intents and purposes is a very healthy baby and never fussy. After receiving her Rotavirus vaccine 2 weeks ago, she suddenly had blood in her stool, started to be a bit fussy, and I also notice mucus in her stool. I took her to her doctor, who said she seemed fine, and that at 2 1/2 months has suddenly developed a dairy allergy...so I am now going off dairy. After reading these articles and the previous posts, I am convinced it has something to do with the Rotavirus vaccine. I am praying this has nothing to do with intusesseption. I have 4 children (2 which did not receive the vaccine and the younger 2 which now have) and have never been told of the issues with the vaccine. I am seriously considering refusing to complete the rest of the Rotavirus vaccine. Upon further consultation with my doctor, and asking if there could be a link with my daughters problems to the vaccine, he still thinks it's a dairy issue. I am confused and concerned.
My son is 3 months old and also started having green/mucousy stool immediately following his 2nd dose of Rotateq. This has gone on for almost 3 weeks with no end in sight. I need to know what to do to treat this as none of the doctors we have seen have any idea. Does anyone know how long this will last?
my little one started having bloody stools within hours of getting her 2 month round of vaccines which included an oral one for rotavirus (rotarix). After tests were ran and weeks of continued bleeding it was alleged that she had a milk protein allergy - even though there would still be blood after i cut all dairy out of my diet as i was exclusively breastfeeding. I was told the only way to know for sure it was an allergy was to do a biopsy of my 2 month old's intestine/colon, which I refused. I have since stopped vaccinating after reading about the countless problems people have had after rotavirus vaccines along with some reports of bloody stools after vaccinations that did not include one for rotavirus. Happy to say that we have had any symptoms since! She is finally healthy and back to her old happy self!!
Yes my son had the same exact problem after his 2 month Rotavirus vaccine.
Let me start off prior to this 2 month appointment he was exclusively breastfed and I was on no sort of diet and ate from all food groups. He was a very good baby and not colicky and was gaining weight and very health. A7
Post vaccine, He was extremely irritable when he used the bathroom and seemed constipated but his stools were always looses (not diarrhea) but normal. After the vaccine started having the "unexplained" blood in stools.
I became very worried and the dr. advised me to either stop breastfeeding (big NO) or to go on an dairy free diet.
I did. I went on it for 2 weeks dairy free with no luck and still bloody stools. Then his pediatrician recommended I tried to eliminate dairy as well as soy eggs wheat nuts. I did even more than that and eliminated the top 8 allergic food and was EXTREMELY careful not to let any whey products or anything else slip in. For another 2 1/2 weeks i stayed on this diet with no luck. I also was extremely malnourished and lost over 20 lbs in a month.
I returned to the same dr.( who never once mentioned it could been related to the stomach flu rotavirus vaccine) with no luckand still having the colicky episodes with blood in stools. She recommended a pediatric gastroenterlogists. He was pretty certain it wasn't a allergy given the fact that my son had been fine prior to the 2 months but with no mention to the vaccine, as I was naive and did not realize it until now that the rotavirus vaccine could of been and is very likely the cause of so much heartache. I wanted to do allergy testing and did to my poor now 3 month old. And had no positive results for any allergies. He also had no other signs of allergies, no rashes and was growing and gain weight. a7
The gastroenterologist said the ONLY other thing that could cause the blood would be a anal fissure. Which was require an upper g.i. scope and to put my baby under anesthetic. I decided not to do that and to just wait it out and the specialist said to give it more time to maybe get whatever I was eating that could of caused the blood out of my system.
I was extremely careful on what I ate and ate next to nothing besides fruits meat and rice. I lost ALOT of weight and at 4 months postpartum my hair was falling all out. And not the normal shedding post baby, this was extreme and I know due to my vitamin deficiency.
At about 4 months the blood was pretty much gone and I just related it to the cows milk eliminated from diet.
He is now 10 months and still breastfed. Unfortunately I am just now realizing that I should start introducing milk back into my diet ever since my phobia of cow products arose from this horrible episode.
I have major discontent with the pediatricians that to do even want to consider that vaccines (which actually have small amonuts of the VIRUS) can cause severe reactions. They under report the reaction to the vaccine control center and I believe it all a conpiracy for them to keep making money from giving all the "necessary" vaccines.
I am also extremely upset that the now RECALLED Rotavirus vaccine that could of had traces of h1n1 was allowed to be given to so many parents without giving more notice of potential, even if rare, side effects.
please contact me if i can be any help to moms or if u need me for anything umkaroom@gmail.com
http://vaers.hhs.gov/index
you can go here to report reactions to vaccine.
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