Sanofi lists Autism as side effect/risk for Tripedia... In package insert!

[nia82]

http://www.vaccineshoppe.com/image.c...pe=product_pdf

I just received an email with the information... I downloaded the PDF, performed a search for autism, and it really is listed!!!! I couldn't believe my eyes. When was that added?

[Lollicup]

Oh great, my DD got one shot with this brand of DTaP.

Adverse events reported during post-approval use of Tripedia vaccine include idiopathic thrombocytopenic purpura, SIDS,
anaphylactic reaction, cellulitis, autism, convulsion/grand mal convulsion, encephalopathy, hypotonia, neuropathy, somnolence
and apnea. Events were included in this list because of the seriousness or frequency of reporting. Because these events are
reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequencies or to
establish a causal relationship to components of Tripedia vaccine.

[Ruthla]

What IS the tripedia vaccine? I'm guessing a specific brand of a pediatric vaccine against 3 different illnesses, but which 3?

[kiara7]

It's the DTaP. And wow. I can only hope parents read the insert before injecting the kids, but I doubt it.

[Marnica]

hmmmm lists SIDS too. I thought doctors always insist that SIDS is not related to vaccination? They don't know what causes it but they know it is not from vaccines....isn't that the party line?

[anewmama]

I believe they list all events reported during the vaccine surveillance period and that this doesn't necessarily mean that the vaccine caused it. One side effect of one vaccine was teething, even.

[carriebft]

This is just the usual shout out to VAERS/survelliance period that the package inserts put on there all the time. Like PP said, some say teething.

I have a few more examples here one sec I will get them

[carriebft]

examples:


so you can see that kind of list here:
http://us.gsk.com/products/assets/us_havrix.pdf


and here:
http://us.gsk.com/products/assets/us_pediarix.pdf
(you even get testicular atrophy and uteropelvic junction obstruction as well as SIDS and Anorexia)

but again, this is just a serial list of everything that happened 30 days after the vaccine.

[Marnica]

Originally Posted by carriebft

examples:


so you can see that kind of list here:
http://us.gsk.com/products/assets/us_havrix.pdf


and here:
http://us.gsk.com/products/assets/us_pediarix.pdf
(you even get testicular atrophy and uteropelvic junction obstruction as well as SIDS and Anorexia)

but again, this is just a serial list of everything that happened 30 days after the vaccine.

Ummm.......... yes enough to make me pause and think for a minute.

[carriebft]

Another example is the rotavirus vaccine. If you look at the study abstract and what they have on the insert they say a kid died in the vaccine group but when you read the actual study you see the infant died in a car accident. they just report anything and everything that happens in that time.

sure it will give people pause who really think temporal relation is that huge that everything 30 days or whatever from the vaccine is related to the vaccine.

[Deborah]

On the other hand, it would be really great if there were some studies of the long-term effects of vaccination.

Are you all satisfied that vaccine studies usually follow the children for, say, four weeks or maybe six?

[carriebft]

which vaccines lack studies that look at more than 6 weeks?

[carriebft]

Or do you mean like 25 year studies?

[Deborah]

No, I was thinking of studies that followed children for two or three years and compared an unvaccinated contingent to the vaccinated group.

I'm going to turn it around. Find me a clinical study that observes children for longer than 6 weeks following vaccination.

[carriebft]

newest rotavirus vaccine study was 1 year I believe.

[carriebft]

Looking through my links folder I also have this one marked from the recent thread on HPV vaccine and age:

http://www.newswire.ca/en/releases/a.../08/c9880.html

not sure how many more examples you want. I have this one a few links down from the HPV one:

http://content.nejm.org/cgi/content/abstract/303/15/833

This Hep B vaccine study had an 18 month follow up


I have so many links here it would take me all night to go through them all but of the first 10 or so I looked at, 3 were 6 weeks+

[carriebft]

http://content.nejm.org/cgi/content/abstract/354/1/23
rotavirus one -Surveillance of one year

[anewmama]

I hear you Deborah. But that doesn't detract from the point being made which is that the list of reported events are not necessarily side effects. It is misleading and disingenuous to present all the side effects as directly related to the vaccine. It detracts from the real argument of pursuing more information if people are willing to believe that vaccines cause teething just because it's listed in the package insert. If you look at the list and are willing to believe the autism connection in this case, then you have to be willing to look at all the symptoms and see the teething as connected as well. I am not willing to believe that vaccination causes teething. So you have to look at the list and then look further as Carrie did above, ie, the death was actually a car accident. You need to look at that list and put it in a little context.

[honeybunch2k8]

Originally Posted by kiara7

It's the DTaP. And wow. I can only hope parents read the insert before injecting the kids, but I doubt it.

Unfortunately, I doubt it as well. I wonder if some doctors even read it.

[xmasbaby7]

Originally Posted by anewmama

I hear you Deborah. But that doesn't detract from the point being made which is that the list of reported events are not necessarily side effects. It is misleading and disingenuous to present all the side effects as directly related to the vaccine. It detracts from the real argument of pursuing more information if people are willing to believe that vaccines cause teething just because it's listed in the package insert. If you look at the list and are willing to believe the autism connection in this case, then you have to be willing to look at all the symptoms and see the teething as connected as well. I am not willing to believe that vaccination causes teething. So you have to look at the list and then look further as Carrie did above, ie, the death was actually a car accident. You need to look at that list and put it in a little context.

I agree with all these points, but isn't the meta point that the safety studies are far from conclusive because there just isn't enough of a rigorous method?

I can see that these studies can prove nothing, but the studies that can prove much more just aren't what is being conducted either because of ethics rulings.

It's soooo convenient!