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Old 06-01-2006, 02:57 PM   #31
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Re: Relactating Where to begin ,lol. Need suggestions!!

From the FDA website: http://www.fda.gov/bbs/topics/ANSWER.../ANS01292.html

June 7, 2004
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FDA Warns Against Women Using Unapproved Drug, Domperidone, to Increase Milk Production
In response to reports that women may be using an unapproved drug, domperidone, to increase milk production (lactation), the Food and Drug Administration (FDA) is warning breastfeeding women not to use this product because of safety concerns. Today, FDA also issued six letters to pharmacies that compound products containing domperidone and firms that supply domperidone for use in compounding.

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.

FDA took these actions because it has become aware that some women who breastfeed and/or pump breast milk are purchasing this drug, domperidone, from compounding pharmacies and from sources in foreign countries to increase breast milk production. Domperidone may increase the secretion of prolactin, a hormone that is needed for lactation.

Although domperidone is approved in several countries outside the U.S. to treat certain gastric disorders, it is not approved in any country, including the U.S., for enhancing breast milk production in lactating women and is also not approved in the U.S. for any indication.

The agency is concerned with the potential public health risks associated with domperidone. 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arrhythmias, cardiac arrest, and sudden death in patients receiving an intravenous form of domperidone that has been withdrawn from marketing in a number of countries. In several countries where the oral form of domperidone continues to be marketed, labels for the product contain specific warnings against use of domperidone by breastfeeding women and note that the drug is excreted in breast milk that could expose a breastfeeding infant to unknown risks. Because of the possibility of serious adverse effects, FDA recommends that breastfeeding women not use domperidone to increase milk production.

The FDA recognizes the immense health benefits that breast milk provides for a nursing infant and is taking these actions today not to discourage women from breastfeeding but rather to warn them not to use this particular drug while they are breastfeeding.

The letters issued by FDA today stated that all drug products containing domperidone (whether compounded or not) violate the Federal Food, Drug, and Cosmetic Act (the Act) because they are unapproved new drugs and misbranded. In addition, distribution within the U.S., or importation of domperidone-containing products, violates the law. FDA informed the warning letter recipients that further violations of the Act may result in enforcement actions including seizure and injunction.

####


In the earlier thread on this subject, someone posted a link to a list of compounding pharmacies that would provide Domperidone. Several of those pharmacies were on the list that received warnings letters from the FDA. The poster who had asked for the information called all of the compounding pharmacies within 200 miles of her and none of them still provide Domperidone.

Believe me I know what it's like to have problems breastfeeding. No one should have to go through what I went through in order to breastfeed my son and I pray that I have a better experience this time because I don't know if I *can* go through that again, especially now with a toddler as well. It breaks my heart to see and hear of other mothers going through similar difficulties and I am so happy to see that people are willing to go to great lengths to be able to continue to breastfeed. But it scares me to hear about mothers getting a drug from another mother without consulting a doctor first. It also scares me to hear about mothers ordering drugs from overseas pharmacies that are not regulated so you don't know what you're getting. ALL drugs have risks. Many times the benefits outweigh the risks, but it's something that you need to understand and make an informed decision about.

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Old 06-01-2006, 03:21 PM   #32
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Your milk does not dry up once you stop taking it, either. When a mother loses her milk supply, the Dom helps you RElactate, not CONTINUE to lactate.
Not always the case. You can ween yourself off of dom, but when I did, I lost my milk. That was probably because of all the stuff I had been through in the hospital and my body chemistry was all out of wack. Whatever the case may be, just be aware that you can suffer a setback if you get off of Dom. I was only just postpardom and still lost my milk. Every body is different, but try not to stress out if you have to continue to take Dom and even if you never achieve a full milk supply. You are still doing what is best for your little one and the stress will only hinder your progress. I actually had to make the decision with dh if bf was still worth it if I had to stay on the drug, and at 4 months after already relactating twice, we decided to move to formula. It was one of the hardest decisions ever but I couldn't see myself staying on meds to nurse. I could not keep my supply unless I was on the Dom, plain and simple. Yes I tried the Natural stuff, I was at The Wellness Center like 2-3's a week, Dom is just much more powerful.

TO A MOM THAT IS SERIOUS ABOUT RELACTATING FROM VERY LOW to ZERO MILK, START WITH THE DOM. EVERYTHING ELSE IS A WASTE OF TIME and $$ IMO. (LIKE I SAID, IMO!!) Herbs are great, but very $$ too. You have to take so much of them just for the slightest bump in milk. I think they work best during growth spurts and such for women who have had no other supply problems. Also, read the back of any herbal treatment-you can still have reactions and pretty much none of it is cleared by the FDA.
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Old 06-01-2006, 10:05 PM   #33
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Re: Relactating Where to begin ,lol. Need suggestions!!

whew!!! lots of info !! lol Thanks for all of your help mamas ... omg get this ... I "sold" my medela PIS to my less fortunate cousin for $30 (she had her baby after the doc told me to switch to formula) I planned on getting the pump back from her as we just bought it in oct of this year .... SHE F'in SOLD IT ON EBAY!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!! ahhhhhhhh I asked her if she was still using it and she laughed and said "haha you wouldn't belive how much a person would pay for a used pump on ebay " OMG WTF I've never been so mad !!!!!!!
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Old 06-01-2006, 10:33 PM   #34
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Re: Relactating Where to begin ,lol. Need suggestions!!

THe FDA is a load of crap. I have no idea about this drug, but all I do know is that I don't listen to a word the FDA says...I research things for myself.
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Old 06-01-2006, 10:38 PM   #35
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Re: Relactating Where to begin ,lol. Need suggestions!!

Yeppers Ephedra ... lol
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Old 06-02-2006, 08:05 AM   #36
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Originally Posted by rrandle
THe FDA is a load of crap. I have no idea about this drug, but all I do know is that I don't listen to a word the FDA says...I research things for myself.
Obviously I haven't done any drug trials for myself so I have to rely on reading other people's research...not just the FDA, I've read everything I can find on the subject. That said, I've posted several times in this thread and the other one that I think the FDA was hasty in banning Domperidone. I wish that the manufacturer would take the steps necessary to get it labeled for lactation purposes (around the world...right now it's not labeled for that in any country and in the countries where it is available, it has a warning that it shouldn't be used by breastfeeding mothers! They have to do that because they've never conducted research on the effects to mothers and babies...even though the general consensus is that it's ok, they've never done the formal trials.) I wish that the manufacturer would do the research and get it labeled for what it's being used for and I wish that the FDA would reconsider their decision to ban the drug in the US altogether. Until they do, the fact remains that it is illegal here. I agree with everyone here...the law is WRONG...it shouldn't be illegal...but it is.

I'm not saying that anyone should or shouldn't take whatever measures they need to in order to get Domperidone, but you do need to know that there are risks. There are risks to taking any drug without a doctor's supervision. There are risks to ordering drugs from overseas pharmacies. There are risks to ordering a drug that you know is illegal in this country. And maybe, just maybe, there are risks to this particular drug, at least for some people. These are all things that you need to consider before choosing to go this route.

I'm not trying to criticize anyone's choices, in fact, I applaud you for doing whatever you have to in order to breastfeed your children. When someone asked about what Domperidone was and where to get it, I tried to answer her question and let her know that it is illegal here. Several people told me I was wrong and that aggravated me because I'm not wrong. The law is wrong...but it *IS* the law. I never intended to start a fight, I was just trying to share the information that I've found.

As long as I've apparently pissed everybody off already, I'll go ahead and say this. Using Domperidone (or any other drug or even herbal supplement) *SHOULD* IMO be a last resort, especially for a breastfeeding mother. There are other alternatives...it is possible to overcome supply issues, and even relactate, without introducing chemicals into your body to try and "trick" it into producing. It's not easy by any means, but in many cases (not all...but many) it is possible and I believe that it's definitely worth trying before resorting to drugs of any kind (herbal or OTC or prescriptions or whatever).

This is another one of those situations where each of us has to make the best decision we can for ourselves and our families based on the information we have at the time. I'm just trying to share some information that apparently a lot of people didn't know, in case that does influence their decisions in any way.
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Old 06-02-2006, 08:14 AM   #37
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Re: Relactating Where to begin ,lol. Need suggestions!!

If you need more domperidone, let me know. I used it and have leftovers here somewhere...all individually sealed. It worked for me. I wasn't relactating though...just increasing low supply (I did almost the same thing as you). I also took fenugreek. PM me if interested as I might not check back here.
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Old 06-02-2006, 09:29 AM   #38
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Re: Relactating Where to begin ,lol. Need suggestions!!

To the mama (or anyone else) above who can't get Domperidone in the US..I'm in Canada where it is readily available and will pick it up for anyone in need for exact cost and shipping.
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Old 06-02-2006, 11:38 AM   #39
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Re: Relactating Where to begin ,lol. Need suggestions!!

My adoptive mom nursed my baby sister with one of the tubes you connect to your nipple..she never did get much milk but she also had never had a baby before ...I used the tube in the hospital before my milk came in only needed to use it once... it was really neat teeny tiny straw like device you still are giving formula but the sucking and stimulation should promote the milk to come in
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Old 06-02-2006, 02:40 PM   #40
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Re: Relactating Where to begin ,lol. Need suggestions!!

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My adoptive mom nursed my baby sister with one of the tubes you connect to your nipple..she never did get much milk but she also had never had a baby before ...I used the tube in the hospital before my milk came in only needed to use it once... it was really neat teeny tiny straw like device you still are giving formula but the sucking and stimulation should promote the milk to come in
I have one, it is called a SNS (supplamental nursing system). I really helps to relieve the stress when you know you need to supplament. You aren't wasting time by having to pump, then feed them a bottle. You get the real stimulation you need along with knowing they are getting enough. Lactaids I've heard, are better.

I have an older style Pump in Style that I was thinking about selling. I also have a bunch of accessories and tubing and extra bottles and even some milk storage bags, if you would like them, pm me.
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