Home Forums Etc... Related Issues FDA Domperidone Article - UGGHHH!!!!!!!!

Okay guys, this is unacceptable and needs to be addressed. Some other breastfeeding professionals are going to be getting behind challenging this, so I'll let you know where to send your letters!

I do not accept this information and want to get the message back to them. In Canada, this is a commonly-used medication for milk production, and anything the US does is often followed by the rest of the world, unfortunately!

The "risks" they mention are standard with many many drugs that the medical world accepts as worth those potential drawbacks. Isolating a drug used for breastfeeding is no coincidence, as far as I'm concerned. Look at all the other drugs being used for off-label purposes (cytotec comes to mind) without a care for potential risks. Again, the money speaks, in my opinion. The establishment is not supportive of breastfeeding. If there is no research or support behind this drug, why doesn't someone do some scientific studies? I'm sure there are enough of us adoptive Mamas who could vouch for its effectiveness and safety!
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FDA Talk Paper

T04-17
June 7, 2004

Media Inquiries: 301-827-6242
Consumer Inquiries: 888-INFO-FDA




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.

Hi Kerri,

I just heard about this, isn't this just awful? To compare intravenous use of the medication with oral use is just attrocious. I've contacted as many health professionals as I can muster together to see what we can do.

fondly,

It is a conspiracy, I'm very confident of that. Some kind of drug company is behind this, and I'm sure it's one with a formula department. I am just so sick and tired of all of this fighting the corporations so babies can have what they deserve. What is this going to mean for all the breastfeeding women in the US who are post-reduction or adoptive Mamas? It means they'll have less milk and will use more formula. I'm a cynic who is getting bitter!!!!!

So what can we do? I've contacted Thomas Hale and will wait and see. I've also signed an online petition to approve domperidone, because it's also not just breastfeeding women that want it. The gastric patients that are importing it are looking to bring it into the US too. How do we contact the FDA? What kind of higher-up folks do they listen to? Because somehow I doubt it's the nursing Mamas who are doing everything they can to prevent using formula.

I'm so disappointed in this. Another witch-hunt over something benign.

Kerri

Hi Everyone,

Here is Tom Hale's response to the recent FDA Warning about domperidone. It may be viewed at this link as well: http://neonatal.ama.ttuhsc.edu/lact/html/fda_warning_on_domperidone.html

"FDA Warning on Domperidone

Dear Colleagues:

The Food and Drug Administration called yesterday to inform me of their decision to issue a warning on the use of domperidone in breastfeeding mothers. They stated that they became concerned after the publication of several case reports of domperidone toxicity following high dose "intravenous" domperidone in some patients.
Unfortunately, the correlation of intravenous administration with oral administration of domperidone is simply ludicrous. Domperidone is only 13-17% bioavailable orally. Peak plasma levels in recipients following 20 mg orally is only 15-18 ng/ml. Peak plasma levels following a 10 mg intravenous dose is reported to be 1200 ng/ml, almost 80-150 fold more than oral administration. I don't really see how high doses intravenously even correlate with the use of low to moderate doses orally in breastfeeding mothers.

They also stated that the data on the use of domperidone in breastfeeding mothers was limited, improperly designed, and did not give a good estimate of the transfer into human milk, or to the infant. While I agree that the data on domperidone is somewhat limited, these complaints could be used with virtually every other drug we have on the US market today, including all the anti-asthma products, analgesics, antidepressants, and dozens of commonly used drugs. Why hasn't the FDA issued warning on Advair, morphine, Reglan, Demerol, or Prozac. We certainly haven't stopped using all these drugs because of limited data in breastfeeding mothers.

Domperidone has been used world-wide for many years with an excellent safety record. It is approved for use in all the worlds largest and finest countries, including England, Australia, Canada, etc. This warning from the FDA has nothing to do with its safety, its all about the importation of drugs from Canada and control by this federal agency. They simply want to stop the importation of all drugs, particularly those used by the elderly, and now the breastfeeding mother.


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.


Thomas W. Hale, R.Ph., Ph.D.
Professor of Pediatrics"
Texas Tech University School of Medicine
Amarillo, Texas

Hope this helps. Fondly, Lenore

Thanks for posting that, Lenore. He got back to me with the same notice, but I forgot to post it.

Anyway, could you talk to Jack about it and see what his input is? How can we help women in the US find a source, or fight this ridiculous witch-hunt? I just have had a couple of people ask me to talk to him (Dr. Newman), but I'm sure he doesn't want to repeat all the same info to everyone.

Look at all the published (US) literature that suggests domperidone! Tom Hale says to keep using it as usual, basically, but how are women to get it if we don't have any other reliable sources? If compounded pharmacies aren't allowed to mix it, which is absolutely RIDICULOUS, and they're going to crack down on imports, where does this leave women? Reglan?!

I am just FUMING over this. (If you can't tell. LOL) People died in testing Viagra, but it was still HEAVILY advertised and prescribed. But, you know, male sexuality is much more important to the FDA than infant nutrition, apparently.

Kerri

Now Viagra is being marketed to women too ... so the FDA has REALLY come so far (j/k - LOL)! What comes around goes around.

Hi Kerri,

I'm as upset about this as anyone, I'm sure you can imagine. As far as I know, several colleagues in the lactation field including Dr. Newman are in the process of creating and distributing their responses to the FDA announcement. Right now we just have to sit tight and wait for more news.

In the meantime, our friends in NZ are still coming through for us.

Fondly,

Hi Kerri and everyone,

Here's a very important article by an MD who is also a breastfeeding mother using domperidone to help her own milk supply. She raises some important issues.

http://www.zongoo.com/article7701.html

Fondly,

Terrific article ... thanks Dr. Louise and Lenore!