Home Forums Induced Lactation aka Adoptive Breastfeeding Medical Interventions to Induce Lactation/Increase Milk Supply Has anyone read this info from the FDA re: Dom?

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arrhythmias, cardiac arrest, and sudden death in patients receiving an intravenous form of domperidone that has been withdrawn from marketing in a number of countries.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.

I am thinking that this is a scare tactic. The FDA is always trying to cut out people from buying drugs elsewhere.
But does anyone know where it is in writing that the American Academy of Pediatrics approves the use of domperidone in breastfeeding moms?
Thanks

Here is a reply from Dr Hale, which I copied over from another board......
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

Thank you Dawn. It is good to have this information. <img src="/ubbthreads/images/graemlins/smile.gif" alt="" />

Dawn,

Where did you find this information. Here is another excerpt from http://msnbc.msn.com/id/5165308/:

Serious side effects reported
Monday, the FDA ordered an end to compounded domperidone and the detention of imports.

FDA counts over 2,000 reports of side effects from 33 countries related to domperidone. An intravenous form was banned worldwide after it was linked to cardiac arrest, sudden death, and irregular heartbeat. Seizures and other neurologic side effects have been reported with high oral doses, FDA warned.

Abroad, the maximum oral dose for stomach disorders is 80 milligrams a day. But FDA officials cite reports of women taking twice that much to increase breast milk production. While FDA says little is known about effects on infants, presumably the mother?s dose determines how much is excreted into breast milk.

In addition, using certain other medicines, such as the antibiotic erythromycin, raises blood levels of domperidone even further, FDA warned.

Yohopi, go to the "Related Issues" topic this discussion is on over there too with some links on articles.

does this mean we will not be able to get Domp even over seas. Should I stock up now before its too late?
Julie

The FDA warning was so nicely timed with the first day of the BF Media Campaign. Sometimes I wonder why the accountable person overseeing such an important public health agency such as the FDA does not ensure that the Public Relations Department and the Research Department communicate better. Perhaps it is a strategy of providing inadequate and poorly stated data to stir the media, which ironically, or not so, is so timely for the formula companies. One seasoned BF professional told me that it seems each year around the BF Media Campaign, there is a story that promotes formula or attacks breastfeeding. If any of you are asking, "What BF Media Campaign?" .... then unfortunately, the strategy is working! It makes me sad.

Hi Christina,

You hit the nail right on the head. We in the lactation field believe that the timing and the announcement itself were politically motivated. There is a lot of talk about how the FDA was made aware of the use of domperidone by breastfeeding mothers if they did not consult anyone in the lactation field. One has to think that there is something else going on beneath the surface.

Fondly,

How rude! I'm glad Thomas W. Hale, R.Ph., Ph.D., Professor of Pediatrics, Texas Tech University School of Medicine clarified some of the vague FDA statements and offered specific information. By the way, the link to reference his statement is: Texas Tech University School of Medicine Breastfeeding Pharmacology Page

Aloha,
Christina