Pregnancy and Whooping Cough Booster Questions - Page 2

[Turquesa]

Well, I just did a search and pulled up a strongly worded article from Dr. Bob Sears. http://www.huffingtonpost.com/dr-bob-sears/government-approves-okays-untested_b_674147.html

Since I'm not one to settle for secondary sources, a commenter led me to this piece from the Centers for Disease Control: www.cdc.gov/vaccines/acip/committee/guidance/rec-vac-preg.html

Click from the feeder page to open the Pregnancy Principles PDF. And note that although they were written in 2008, the feeder page states that these guiding principles "are still applicable today." Scroll down to page 7, 1C:

"Concerns about vaccination of pregnant women
i.Lack of data to make evidence-based decisions.
1. No or limited well-controlled trials to establish efficacy of vaccines in pregnant women or . their offspring.
2. No or limited post-licensure studies of efficacy or safety, eg, from registries, VAERS, or Vaccine Safety Datalink.
3. No or limited animal data
4. No or limited data on burden of illness."

(Bear with me. I've given up on the quote feature for now).

So, um, yea. I'd have some second thoughts. And third, fourth, fifth, and 105th.

The OP can listen to our bantering and decide for herself. Hopefully the back-and-forth has been helpful to her. But in my mind, to consent to a medical intervention in the absence of science doesn't seem terribly pro-science.

[Rrrrrachel]

I don't take anything in sears says seriously.

Sorry, wasn't trying to distract anyone from anything with the homeopathy talk, just use it as an analogy. Tdap is classified as class c because there havent been controlled trials with pregnant women. That is the case with many many drugs that are used during pregnancy, as well as many homeopathic and herbal remedies that are routinely used (but aren't as regulated as tdap). Manufacturers inserts are a great source of information, but they are often misinterpreted. They kind f have to be taken with a grain of salt.

[Rrrrrachel]

And it's not really the "absence of science," there absolutely is science that points to the safety and effectiveness of tdap in pregnancy, it's just the absence of a very specific kind of science that hardy ever exists when it comes to pregnant women.

[BeckyBird]

Originally Posted by Rrrrrachel 

it's just the absence of a very specific kind of science that hardy ever exists when it comes to pregnant women.

This is probably why so many pregnant women are wary of the vaccine.

[Rrrrrachel]

Yet many of those same women will take other drugs and remedies that haven't been examined nearly as much without a second thought.

[japonica]

Originally Posted by Rrrrrachel 

Yet many of those same women will take other drugs and remedies that haven't been examined nearly as much without a second thought.

I think that's a bit of a generalisation. In my experience on this board and others, mothers-to-be seem to become more anxious about anything they consume. I've seen discussions about tuna, soft ice cream, paracetamol, feta cheese, steaks, herbal tea, and the list goes on. I think it's rare that women take just anything during pregnancy without a second thought, excepting those with prior addictions and the like.

[erigeron]

Originally Posted by BeckyBird 

You love evidence-based medicine, right?  I can't think of anything LESS evidence-based than using medicine off-label.

"Off-label drug use occurs when a physician prescribes medication to treat a condition before that use has been approved by the FDA." Repeat, BEFORE that use has been APPROVED....

Well, this isn't as clear-cut as it seems because it's the manufacturer who has to apply for the new indication, and if the manufacturer chooses not to (either because they don't think it's worth the money to study that indication, or because the drug is off-patent, or for a host of other reasons), it just plain won't get approved for that indication, but that doesn't mean that it doesn't produce good results. When treatment guidelines are developed by groups of doctors, the level of evidence for each point in the guidelines will be given, and "expert consensus" is considered to be a level of evidence. FDA approval for a condition is not the only way of establishing that a drug treats a condition. 

[Rrrrrachel]

Originally Posted by japonica 

I think that's a bit of a generalisation. In my experience on this board and others, mothers-to-be seem to become more anxious about anything they consume. I've seen discussions about tuna, soft ice cream, paracetamol, feta cheese, steaks, herbal tea, and the list goes on. I think it's rare that women take just anything during pregnancy without a second thought, excepting those with prior addictions and the like.

How many pregnant women use red raspberry leaf tea? Or nettles? Or epo? Or cohosh? Where are the controlled studies for those?

It's really getting to the point that its neither here nor there, but class c drugs are used all the time in pregnancy. The caution is that you should consider if the benefit outweighs any POTENTIAL risk. Not that they shouldn't be used or that there is a known risk.

[japonica]

Originally Posted by Rrrrrachel 


How many pregnant women use red raspberry leaf tea? Or nettles? Or epo? Or cohosh? Where are the controlled studies for those?

It's really getting to the point that its neither here nor there, but class c drugs are used all the time in pregnancy. The caution is that you should consider if the benefit outweighs any POTENTIAL risk. Not that they shouldn't be used or that there is a known risk.

I didn't mention RRL or nettles or whatever. I said most women do not take anything WITHOUT a second thought. I'm sure some women are concerned, but take herbal remedies anyway. Or others take herbals, perhaps equating natural with safe. I'd hope that any of them would consult with their HCPs first, like with any medication. But women who just down anything without a second thought while pregnant...food or medication or herb...I've yet to meet one. I have no doubt they exist. They just haven't crossed my path yet.

Hmm. I don't remember posting that class C drugs should be avoided at all costs. Nor even that off label use was verboten. I wrote that, in the specific case we were discussing, Adacel, that the risk of pertussis infection in mother and/or infant (and the documented protection passed along to the newborn from a prenatal booster) needs to be evaluated in conjunction with the supposed observed risk of adverse events due to repeated tetanus vaccination (according to the CDC). If the HCP and patient feel the benefit outweighs the risk, and everybody's happy with their choices, then no issue, is there? Sounds similar to your statement about potential risk above. 

[Marnica]

Originally Posted by Rrrrrachel 


How many pregnant women use red raspberry leaf tea? Or nettles? Or epo? Or cohosh? Where are the controlled studies for those?

It's really getting to the point that its neither here nor there, but class c drugs are used all the time in pregnancy. The caution is that you should consider if the benefit outweighs any POTENTIAL risk. Not that they shouldn't be used or that there is a known risk.

Yes RRL tea hasn't been used for it's indication in pregnancy for thousands of years or anything. Personally Ill take my chances with RRL and nettles over any pharma product. 

[Rrrrrachel]

Yet by the standards we use to classify drugs in pregnancy both would be class c.

[Marnica]

Originally Posted by Rrrrrachel 

Yet by the standards we use to classify drugs in pregnancy both would be class c.

well sort of - at least the part about not enough studies in pregnant women. Category C indicates that there have been adverse effects noted on the fetus in animal reproduction studies as well but of course they are not doing animal studies with RRL. Ill still take my chances with certain herbals that have been used for thousands of years 

[nia82]

OP, there are excellent posts here. I personally do not allow to be vaccinated in pregnancy with anything. If you are concerned about it, get Tdap after birth. I'm not big on vaccines, I select very few, but pertussis in particular has a poor track record. I would have even gotten the Tdap if it WAS time for a tetanus booster, but it isn't. It hasn't been 10 years yet and also, I run titers and last time it lasted significantly longer than 10 years. My doctor back home in the EU did advise against tetanus boosters as long as your titers are high as it leads to a significantly increased risk of bad side effects.

[Rrrrrachel]

What's the poor track record for pertussis?

Being vaccinated after delivery does not offer the same benefits as vaccination during third trimester.
Edited by Rrrrrachel - 1/15/13 at 7:27pm

[Rrrrrachel]

Originally Posted by Marnica 

well sort of - at least the part about not enough studies in pregnant women. Category C indicates that there have been adverse effects noted on the fetus in animal reproduction studies as well but of course they are not doing animal studies with RRL. Ill still take my chances with certain herbals that have been used for thousands of years 

No, not sort of. Class c includes drugs for which studies are not available, not just studies that animal studies have showed harm for.

I'm just trying to put the class c thing in perspective. I used rrl during pregnancy and I believe it's safe, too. The picture for nettles and other remedies used during pregnancy aren't as clear, btw.

[emma1325]

Originally Posted by Rrrrrachel 


How many pregnant women use red raspberry leaf tea? Or nettles? Or epo? Or cohosh? Where are the controlled studies for those?

It's really getting to the point that its neither here nor there, but class c drugs are used all the time in pregnancy. The caution is that you should consider if the benefit outweighs any POTENTIAL risk. Not that they shouldn't be used or that there is a known risk.

The clear difference being that women generally are not being coerced into taking those supplements by medical providers.

[Rrrrrachel]

I don't think that's the case with tdap, either.

[Marnica]

Originally Posted by Rrrrrachel 


No, not sort of. Class c includes drugs for which studies are not available, not just studies that animal studies have showed harm for.

I'm just trying to put the class c thing in perspective. I used rrl during pregnancy and I believe it's safe, too. The picture for nettles and other remedies used during pregnancy aren't as clear, btw.

I know what Class C means thanks... I said sort of because you did not mention animal studies so yeah sort of and I think I specifically said the part about no studies in pregnant women. 

[Rrrrrachel]

I don't understand. No animal studies and no people studies makes it a class c. What did I leave out that makes them only sort of class c?

[Marnica]

Originally Posted by Rrrrrachel 

I don't understand. No animal studies and no people studies makes it a class c. What did I leave out that makes them only sort of class c?

Not sure how much clearer I can be. Ok Ill try. 

you said upthread: Tdap is classified as class c because there havent been controlled trials with pregnant women.

yes this is true - but what you did not mention (hence why I said sort of)  is that class c also means that there have been animal studies that have found harm to the fetus.  So what you just said "no animal studies and no people studies make it class c is incorrect." 

I think you are getting hung up on my use of "sort of."  My point was that you only mentioned half of what makes a class c drug class c, not that what you said was wrong or only partly true.