the only thing I know about it, is that it's approved in other countries. For some reason they haven't here but all I have heard is good things about it.
FDA issues warning on Domperidone....
Sorry I'm not good at providing links, but you can find the article on any health service, Reuters or AP. We were just talking about Domperidone here. I just ordered some online for a friend with a very low, nonexistent supply and a 4 month old. She has all kinds of problems establishing and maintaining a milk supply, and wants to try this, along with pumping, etc., as a last resort. Although, this drug has not been approved in the U.S, I have read it has been safely used for many years to increase lactation. The FDA says that it has received reports of heart problems from the INTRAVENEOUS form of the drug. They also mention women taking "twice the recommended dose." What do y'all think??? Would the FDA actually have some motivation to keep a safe drug away from women who need it to increase lactation??? I can't find any details about women having problems using the pill form in doses recommended for lactation. I just don't know what to think. I am reading all this stuff saying, it's safe, although the use for lactation has not been approved, etc....and then this FDA warning comes out. Apparently, they are cracking down on the sale from compounding pharmacies in the U.S. Should I discourage my friend from taking it?
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My first reaction was "I wonder if the FDA is being persuaded by formula companys or anything like that".
Maybe it does have some rare side effects, but so does Viagra. Of course we all know erections are far more important in this society than breastfeeding.... grrr... And how many guys have take twice the amount of Viagra?? how many have died taking it when they shouldn't have been taking it? Does the FDA pull it? Oh no...
I bet if they put as much research into lactation inducing drugs as they did into producing erections, we'd have far more available options when nature doesn't work well.
Why would anyone be using an IV form of it anyhow?
If it were me and I didn't have a heart condition, then I'd still take it.
I bet if they put as much research into lactation inducing drugs as they did into producing erections, we'd have far more available options when nature doesn't work well.
Why would anyone be using an IV form of it anyhow?
If it were me and I didn't have a heart condition, then I'd still take it.
it is approved for use in breastfeeding mothers by the AAP. that means that "yes it is excreeted in breastmilk. we know that and we have determined it is OK" of course so is sudafed which lowers supply LOL but I digress. the formula companies and the FDA wouldn't be in cahoots now, would they?
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http://www.fda.gov/bbs/topics/ANSWER.../ANS01292.html
This is really REALLY making me mad ... the coincidences are just too great that someone somewhere didn't want this press release issued at the time of the BFing Campaign.
This is really REALLY making me mad ... the coincidences are just too great that someone somewhere didn't want this press release issued at the time of the BFing Campaign.
Quote:
Can you find a link for this? I can't find on AAP site.
This needs to be a Mothering Action Alert and pronto! We need to bombard the FDA with requests to study this drug with HHS funds b/c Janssen won't do it.
Edit: check out this paragraph, it is literally giving me chills.
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It is well worth reading Jack Newman's handout on domperidone, apparently it does not have cardiac side effects and was originally prescribed to babies for gastrointestinal complaints.
http://www.kellymom.com/newman/domperidone_01-03.html
Originally Posted by flminivanmama it is approved for use in breastfeeding mothers by the AAP. that means that "yes it is excreeted in breastmilk. we know that and we have determined it is OK" |
This needs to be a Mothering Action Alert and pronto! We need to bombard the FDA with requests to study this drug with HHS funds b/c Janssen won't do it.
Edit: check out this paragraph, it is literally giving me chills.
Quote:
| The Agency also is issuing an Import Alert which alerts FDA field personnel to be on the lookout for attempts to import this drug so that it can be detained and refused admission into the U.S. if appropriate. |
http://www.kellymom.com/newman/domperidone_01-03.html
Quote:
Yeah, I really don't go in for conspiracy theories....BUT, if you think about it...... If every adoptive mother, or woman with physical reasons for no/low supply, were pursuaded to attempt lactation with the assistance of Domperidone, the formula companies would lose AT LEAST $1000 per baby. If that were say, only !0,000 babies a year, worldwide, that would mean $1 million dollar loss per year for the formula companies. If this drug were approved, I think there would be tremendous demand. So many women give up on breastfeeding because of low supply (whether real or imagined), and just can't seem to reverse it. In our culture, (unfortunately) taking a medication/drug, is highly acceptable. In this case, I think the benefits of exclusive breastfeeding for these moms and babes would outweigh the potential, rare effects of the drug. And, yes, very strange that we have at least 3 drugs on the market to help men maintain erections, but none approved to help increase milk supply. What's up with that??? I have an adoptive mom acquaintance who has been taking domp for six months, I hope she doesn't have any problems finding it, to continue breastfeeding.
Originally Posted by JaneS http://www.fda.gov/bbs/topics/ANSWER.../ANS01292.html This is really REALLY making me mad ... the coincidences are just too great that someone somewhere didn't want this press release issued at the time of the BFing Campaign. |
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ITA - this just burns my butt
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and this
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Gee, where's that same agency when kids have reactions to vaccines? grrrrrr
and I just sent info about domperidone to my cousin this morning who's having trouble pumping enough milk for her nipple confused 4 week old (since the hospital gave her a bottle - off topic and long story there - that one makes me mad too)
Oh yes, it is interesting that we have drugs like viagra and cialis advertised on tv but breastfeeding can hardly be promoted. I just love the cialis ad where men are advised to go to the ER if they have erections lasting more than 4 hours - WTF!
Sorry, end of rant. I will write a letter if someone can tell me how.
Originally Posted by JaneS http://www.fda.gov/bbs/topics/ANSWER.../ANS01292.html This is really REALLY making me mad ... the coincidences are just too great that someone somewhere didn't want this press release issued at the time of the BFing Campaign. |
and this
Quote:
| The agency is concerned with the potential public health risks associated with domperidone. |
and I just sent info about domperidone to my cousin this morning who's having trouble pumping enough milk for her nipple confused 4 week old (since the hospital gave her a bottle - off topic and long story there - that one makes me mad too)
Oh yes, it is interesting that we have drugs like viagra and cialis advertised on tv but breastfeeding can hardly be promoted. I just love the cialis ad where men are advised to go to the ER if they have erections lasting more than 4 hours - WTF!
Sorry, end of rant. I will write a letter if someone can tell me how.
check out Dr. Hale's response!!!!!!
Quote:
http://neonatal.ttuhsc.edu/lact/html...mperidone.html
Quote:
| The reality is that I still believe domperidone is the safest product we can use for stimulating milk production in some women. It is still true that in many mothers it offers the only hope for maintaining a milk supply for their infants and preventing the untoward effects of formula. When I asked them if they had consulted with anyone in the field of human lactation about the consequences of this action, they had not. When I asked them what breastfeeding mothers were to do, they answered contact their physician for options, or switch to formula. I do not propose to advise you as to what you should do, but as for me, I simply choose to ignore them, and their advice. |
http://neonatal.ttuhsc.edu/lact/html...mperidone.html
From the FDA warning: "There have been several published reports and case
studies of cardiac arrhythmias, cardiac arrest, and sudden death in
patients receiving an intravenous form of domperidone that has been
withdrawn from marketing in a number of countries. "
So.... I take it that if you take "a form of domperidone" (but not exactly the same stuff??) intravenously, then you run the risk of cardiac problems, so no one can take something that might be chemically different orally? This sounds like those studies that Chemical X causes cancer in mice when injected at concentrations 10 million times the quantities that humans consume, therefore Chemical X causes cancer.
Please, someone tell me where to send a letter.
studies of cardiac arrhythmias, cardiac arrest, and sudden death in
patients receiving an intravenous form of domperidone that has been
withdrawn from marketing in a number of countries. "
So.... I take it that if you take "a form of domperidone" (but not exactly the same stuff??) intravenously, then you run the risk of cardiac problems, so no one can take something that might be chemically different orally? This sounds like those studies that Chemical X causes cancer in mice when injected at concentrations 10 million times the quantities that humans consume, therefore Chemical X causes cancer.
Please, someone tell me where to send a letter.
Quote:
Don't apologize, use the anger!!! I'm calling them right now, let's clog their phone lines today!
Contact info for FDA:
http://www.fda.gov/comments.html
Edit:
Here's a direct form for complaints:
http://www.fda.gov/cder/comment/commentdrug.htm
Originally Posted by schatz Sorry, end of rant. I will write a letter if someone can tell me how. |
Contact info for FDA:
http://www.fda.gov/comments.html
Edit:
Here's a direct form for complaints:
http://www.fda.gov/cder/comment/commentdrug.htm
Quote:
That's our market driven medical system for you.
It takes enormous amounts of $ to do the required phases of drug testing for FDA approval. Companies/investors won't foot the bill unless they are assured of a large and patentable market. Meaning that they can be the only ones that own the rights to the "drug". Which is why you don't see studies done on natural/herbal supplements b/c no one can patent them.
Lots of men want erections and will pop a pill to get one, so it's a large and attractive market for companies. It's possible that Janssen just doesn't see a large market for mama's with low supply. Or that the testing would be controversial.
God, Goddess, Mother Earth Bless Dr. Hale, because without him we would have NO studies at all for bf'ing mamas.
Originally Posted by Raven67 And, yes, very strange that we have at least 3 drugs on the market to help men maintain erections, but none approved to help increase milk supply. What's up with that??? |
It takes enormous amounts of $ to do the required phases of drug testing for FDA approval. Companies/investors won't foot the bill unless they are assured of a large and patentable market. Meaning that they can be the only ones that own the rights to the "drug". Which is why you don't see studies done on natural/herbal supplements b/c no one can patent them.
Lots of men want erections and will pop a pill to get one, so it's a large and attractive market for companies. It's possible that Janssen just doesn't see a large market for mama's with low supply. Or that the testing would be controversial.
God, Goddess, Mother Earth Bless Dr. Hale, because without him we would have NO studies at all for bf'ing mamas.
Dang. Dr. Hale sounds pissed.
I wonder if some drug company could get it approved via the orphan drug act?
http://www.fda.gov/orphan/oda.htm
Thanks for the FDA complaint link. I'm composing my response in my head. It may take me a few days to come up with something that doesn't sound like "GET YOUR HANDS OUT OF FORMULA COMPANIES' POCKET"
I wonder if some drug company could get it approved via the orphan drug act?
http://www.fda.gov/orphan/oda.htm
Thanks for the FDA complaint link. I'm composing my response in my head. It may take me a few days to come up with something that doesn't sound like "GET YOUR HANDS OUT OF FORMULA COMPANIES' POCKET"
Quote:
That's where I'm at. Right now I just want to rant at them but I don't want to sound like a blubbering idiot.
Too bad there aren't more doctors who are pissed like Dr. Hale.
Originally Posted by Geofizz Dang. Dr. Hale sounds pissed. It may take me a few days to come up with something that doesn't sound like "GET YOUR HANDS OUT OF FORMULA COMPANIES' POCKET" |
Too bad there aren't more doctors who are pissed like Dr. Hale.
Quote:
it's listed as an L2 and approved by the AAP in Hale MMM....
Originally Posted by JaneS Can you find a link for this? I can't find on AAP site. |
Quote:
Found it!
In a AAP Policy statement from 2001. Table 6.
http://aappolicy.aappublications.org...rics;108/3/776
Originally Posted by flminivanmama it's listed as an L2 and approved by the AAP in Hale MMM.... |
In a AAP Policy statement from 2001. Table 6.
http://aappolicy.aappublications.org...rics;108/3/776
Quote:
I've been sending this to every agency and official I can think of right now. Including all the members of the Senate Ctte on Health listed in Mothering's Action Alert "Formula Co's Play Foul". I'm not so sure how it sounds, but it's something. I'm so angry I've gotta send it today!
Quote:
Originally Posted by schatz That's where I'm at. Right now I just want to rant at them but I don't want to sound like a blubbering idiot. |
Quote:
| I am writing to express my extreme outrage at today's release of the FDA's warning on domperidone coinciding with the launch of the HHS Agency's National Breastfeeding Campaign. In the words noted breastfeeding pharmacology researcher, Dr. Thomas Hale, "It is still true that in many mothers [domperidone] offers the only hope for maintaining a milk supply for their infants and preventing the untoward effects of formula. When I asked them if [the FDA] had consulted with anyone in the field of human lactation about the consequences of this action, they had not. When I asked them what breastfeeding mothers were to do, they answered contact their physician for options, or switch to formula." See full text of Dr. Hale's letter here: http://neonatal.ttuhsc.edu/lact/html...mperidone.html With the current risks of formula, including INCREASING DEATH RATES FOR FORMULA FED BABIES, what are women supposed to do in order to save their breastfeeding relationship if it is in jeopardy? I'm appalled and disgusted. A better solution would be to work with the HHS to do the studies on domperidone for the good of the health of future generations and save some babies' lives. |
Well, I'm not using the intravenous kind but I am taking it in pill form. If it were'nt for this drug I would'nt be able to attempt at relactating. It is approved here in Canada as a lactation drug, and the docs prescribe it all the time. It was prescribed in the beginning by my family doc when we had the supply issues, but I decided to deal with my depression so I could be a good mama to all of my kids. When I decided to relactate it was prescribed by my lactation doc and she was thrilled that I was open to taking it. Both of my docs have great faith in it, so much so that they started me off on a very low dose and are gradually increasing it as I continue to lactate.
Same goes -- I can assure you that I didn't die from Dom.
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