To wonder why there aren't more breastfeeding studies?

[cityrat79]

I'm currently breastfeeding my 6 month old, and will probably wind down within the next 4 months or so as she starts solids.

I would be very willing to keep my milk going for studies to test whether certain substances pass into breastmilk. Being told "we don't know if it passes into the milk" about various medications really irritated me and I'd like to do something to help future mothers once I've finished feeding my child.

Surely researchers must be crying out for volunteers? But I cannot find a single study. AIBU to think there should be a national database for volunteering for this sort of thing?

lol CountessOfStrathearn you're invisible!

"It's not that we don't know whether substances pass into breastmilk. We do, and we know the quantities. It's that we don't know enough about the effects on the baby. And that isn't something you can design ethical trials for."

This. If you look at something like Lactmed you can see lots of information about the concentrations of different drugs in breastmilk:
toxnet.nlm.nih.gov/newtoxnet/lactmed.htm

In some cases they do mentioned reported effects on baby, but that's more "x number of mothers were going to be on this drug anyway and we asked them what happened" than "we made these mothers take this drug for our study and report on how their baby was".

The whole "we don't know if it passes into the milk" sounds more like an excuse made by HCPs who can't be arsed looking stuff up.

(in fairness, for a lot of the Lactmed entries they can give a fairly sound recommendation that the drug is safe for the breastfed infant as eg it only passes into milk in miniscule quantities, or is not well-absorbed orally)

Each study would test one drug. But there could be lots of money for pharma companies if the drugs were proved safe

And how much do you think it would cost them if the drugs proved to be not safe?

I imagine the main reason is because it's unethical to do studies where otherwise healthy babies might be put at risk.

It's the same reason so many medicines aren't licensed for use during pregnancy. It's nothing to do with them being found unsafe - it's because it wouldn't be ethical to test them in order to find them safe.

"Medications aren't the most common reason not to breastfeed (or deciding factor in when to stop)"

No, but it definitely happens. I'm still pissed off at a locum doctor who told me I needed to wean to go on antidepressants - fortunately I got a second opinion (from a perinatal psych team, who had a lot of expertise) who told me that it was FINE, as did my usual GP. And I've heard of plenty of women who've either not been given appropriate medication or told they can't have it until they stop BF.

That said, the reason for recommending women to stop BF to go on a particular medication is frequently ignorance on the HCP's part ("doesn't say on the patient insert that it's safe for breastfeeding, must tell her to wean") rather than the information genuinely not being there, so I think the need for "more studies" is a bit of a red herring. More education for doctors and pharmacists would be a lot more useful.

I agree with what other posters said -- there is a fair amount of data on the transfer of drugs and metabolites into breast milk. Take s look at Wendy Jones' book "breastfeeding and medication". The critical evidence - what those dosages of drugs would do to bavies of different ages- is the missing data generally - and that's hard to generate. Jones explains in her book how inferences on likely safety of drugs in breast milk are to the baby, based on other sources of information.

leedy

So, for the people who told you it was fine, I assume the test was done where a lactating mother took anti-depressants and the level that made it into her milk was recorded. That level was then given to a bay and the baby was monitored for adverse effects.

Assuming that my scenario occurred, is that fair?

We've all been told breast is best but, is it better than formula when you add unknown consequences into the mix? I think it's hard to argue against the locum Dr you met. You're right that if it doesn't say safe for breastfeeding then the best option is to suggest weaning. I don't know why you're arguing against it.

Are you putting you and your child in for medical testing?

Ok, so I have learned from this thread that the difficulty is not testing the breastmilk but testing the effect that the breastmilk (assuming it does contain x concentration of the medication) has on a baby. That is obviously harder to do ethically.

So it's not that we don't know if it passes to the baby, it's that we don't know what effect that might have? But doesn't breastmilk filter out a lot of substances completely (eg paracetamol)?

So it's not that we don't know if it passes to the baby, it's that we don't know what effect that might have? But doesn't breastmilk filter out a lot of substances completely (eg paracetamol)?

paracetemol yes.

Erm, yes, herecomethepotatoes, the drug I was on (sertraline) is very well studied in BF mothers because it's one that's commonly used for postnatal depression. The level of the drug in the milk of mothers who used it has been extensively tested and there have been studies where the babies of mothers on sertraline have been monitored for adverse effects (few) and their blood levels of the drug measured (almost to actually undetectable). It wasn't like they gave it to women who weren't depressed just to see what happened to their offspring, they gave it to women who needed antidepressants and made the decision that the risk of using the drug was less than the risk to the baby and mother of abrupt weaning. You can see the results if you look up the drug in Lactmed (which weirdly won't let me link to the actual page).

The doctors who recommended it to me used the recommendations in, amongst other things, Hale's Medications And Mother's Milk, which is pretty much the bible on medication while breastfeeding.

Oh, and almost no prescription medication says that it's safe for breastfeeding because there is pretty much no way to definitely prove that it is. You can, however, say that the risk is negligible, and that there is no appreciable reason to wean to take the medication. Also saying that weaning is "the best option" completely ignores the benefits of breastfeeding, or indeed the risk of sudden weaning (eg with PND abrupt weaning can bring about a massive hormonal crash which could actually make the illness worse).

Also you'll be glad to know that the baby I fed on sertraline (and several interesting antibiotics) is now a strapping six year old with the appropriate number of heads.

"Are you putting you and your child in for medical testing?"

No, because the drug has already been extensively tested.

But doesn't breastmilk filter out a lot of substances completely (eg paracetamol)?

Yes, there are a lot of drugs that don't transfer into breastmilk in significant quantities (paracetamol actually does transfer into milk but the rate is very very low). And, as I said, others that do transfer into milk but aren't absorbed well by the gut so won't necessarily have any effect on the child. Eg I fed on IV Vancomycin which is a fairly ferocious drug for the recipient but a)has a low milk transfer and b)isn't well-absorbed orally - hence the IV - so whatever does get into the milk won't get into baby's system.

Oh and agree with bigmamapeach, Wendy Jones is great! She's a specialist pharmacist and she knows tons about this stuff - gives very good advice too. I know a few people who've contacted her about particular meds where they couldn't find appropriate information (eg Lactmed is US-based so doesn't always have drugs that are only licensed here).

Oh, and almost no prescription medication says that it's safe for breastfeeding because there is pretty much no way to definitely prove that it is.

That's what I said.

You can, however, say that the risk is negligible, and that there is no appreciable reason to wean to take the medication.

But that negligible risk will be too much for some.

Also saying that weaning is "the best option" completely ignores the benefits of breastfeeding, or indeed the risk of sudden weaning

No it doesn't. It's saying one is better than the other. It doesn't mean there aren't negative effects. Thst's based on a judgement call and part of that judgement may mean reading a drug's accompanying info. and seeing 'not approved for breastfeeding mothers.'

Also you'll be glad to know that the baby I fed on sertraline (and several interesting antibiotics) is now a strapping six year old with the appropriate number of heads

Of course I am. That fact in itself doesn't mean it's safe though. Seems to use the same fallacy as the "grandmother who smoked 20 a day, drank gin for breakfast and live to 100".

If I was a Dr

Fair enough, people can say "I am not willing to take even the tiniest, weeniest risk when breastfeeding so I will not consume anything that passes into my breastmilk, even if it is very beneficial or enjoyable for me" That's their right. I presume these people also don't put their children in cars.

What irks me is that the actual risk is not discussed. The locum who gave what you refer to as "best advice" that I shouldn't be complaining about just said "it's not recommended". I had no idea whether this meant taking it was a miniscule risk (as is actually the case), a slightly greater risk, or it was the equivalent of giving my tiny baby neat chemo drugs, and as far as I know she didn't know either - she just went by the package insert. The psych team that I eventually dealt with discussed the drug with me extensively, told me about the milk levels, told me about the studies, were very reassuring (one of my symptoms was severe anxiety), told me it was my choice but that their advice was to take the medication and continue breastfeeding if I still wanted to breastfeed - as it happened BF was one of the few things in my life at the time that I felt good at and made me feel in control of this parenting lark. Had I taken the locum's advice at face value I might well have suddenly weaned a three month old who I actually went on to feed for another two years.

"That fact in itself doesn't mean it's safe though. "

No, but I am trusting that the studies that all concluded that the risk to the infant was extremely low were reliable.

"Thst's based on a judgement call and part of that judgement may mean reading a drug's accompanying info. and seeing 'not approved for breastfeeding mothers.'"

TBH, I think for the reasons we've already discussed that piece of information is essentially meaningless when making the decision to take the medication. Almost nothing on prescription will state that it's approved for breastfeeding mothers (unless it's, like, a foot ointment, and even then...) because, as we've been saying, you can't prove it's safe. It's like saying "this drug is a drug".

"It's saying one is better than the other."

Not necessarily, though. You're assuming that you'll get the safest/best outcome for baby and mother by weaning (albeit possibly with negative effects), and anything else is a compromise, while actually in some cases the risk of taking the drug is less than the risk of weaning. How is weaning "better" or "the best option" there?

I suspect it's cheaper and easier to just tell breastfeeding mothers to avoid all of the things you've mentioned. As someone has mentioned there's no money to be made from this kind of research sadly.

leedy you're treating everything I've said as absolutes whereas it's all a continuum.

Some of the professionals you asked said you should take the drug. One said you shouldn't. It worked out well for you but that could be down to luck.

"You're assuming that you'll get the safest/best outcome for baby and mother by weaning (albeit possibly with negative effects), and anything else is a compromise, while actually in some cases the risk of taking the drug is less than the risk of weaning. How is weaning "better" or "the best option" there?"

Again, we're still dealing with value judgements. None of the information has even a statistic attached to it.

It depends on the chance of the baby having negative side effects from a drug vs the effect of a mother not taking it. Neither of these are absolutes so therefore there's guesswork involved.

"No, but I am trusting that the studies that all concluded that the risk to the infant was extremely low were reliable."

So it comes down to trust does it? Everything else you've said appears to be treated as fact and certainly no element of 'trust me, it's fine'.

Fair enough, people can say "I am not willing to take even the tiniest, weeniest risk when breastfeeding so I will not consume anything that passes into my breastmilk, even if it is very beneficial or enjoyable for me" That's their right. I presume these people also don't put their children in cars.

Comments like that make you sound like an idiot whereas everything else you've said is reasonably well balanced.

I'm delighted breastfeeding worked out well for you. There could have been side effects but it seems like the locum was wrong in this case. Is it better for him to be wrong 100 times than correct but ignored once?

Also second donating to baby's in NICU if you're interested in that, I'm sure the baby's parents are eternally grateful to woman who can help out by doing this.

herecomethepotatoes, I genuinely don't understand your point. You seem to be suggesting that risk assessment when taking medication is some kind of hand-wavey phenomenon where nobody really knows anything, do they, and it's all the luck of the draw and "deciding who to trust" and "well some doctors say this, but others say different, and HOW DO WE KNOW WHICH ONES ARE RIGHT".

"Again, we're still dealing with value judgements. None of the information has even a statistic attached to it."

"So it comes down to trust does it? Everything else you've said appears to be treated as fact and certainly no element of 'trust me, it's fine'."

No, no, that's not what I mean at all. I am "trusting" the studies because they seem to be (and are treated by medical professionals as) reliable, peer-reviewed research. You might as well suggest that believing anything scientific at all without having actually performed the experiment yourself is "just trust".

And here's some numbers: toxnet.nlm.nih.gov/cgi-bin/sis/search2/r?dbs+lactmed:@term+@DOCNO+328 (woo, I finally figured out how to get a permalink)

And I agree with you totally that there is an element of risk, it's just that in many cases the level of risk is so low as to be almost non-existent and for doctors to treat all unlicensed-for-BF drugs for infants of all ages as equally dangerous is bad for patients, not "best advice".

"I'm delighted breastfeeding worked out well for you. There could have been side effects but it seems like the locum was wrong in this case. Is it better for him to be wrong 100 times than correct but ignored once?"

What if I had followed the advice of the locum, and I had a negative outcome from that? I'm still not sure why you're so persistently defending her supposed "best practice", (it was a woman), when from everything I've read (and was told by considerably more experienced doctors) she was just plain lazy and couldn't be arsed to find out more about drugs in breastfeeding, like a lot of HCPs. I don't think the fact that I didn't have any problems when I chose to believe an experienced perinatal psychiatrist over a locum GP who admitted she didn't know much about PND was just "down to luck", at all. I got much better information from people who knew more about the issue.

(and I agree, the car thing was facetious, I apologise)

This is also interesting (the key point being "it is safe to continue breastfeeding when taking most medications"):

www.breastfeedingnetwork.org.uk/wp-content/dibm/the%20safety%20of%20drugs%20passing%20to%20the%20baby%20through%20breastmilk.pdf