# FDA warns against use of Domperidone by nursing mothers **URL:** \ **Category:** Great Debates\ **Created:** [June 10, 2004, 3:05pm UTC](https://boards.straightdope.com/t/fda-warns-against-use-of-domperidone-by-nursing-mothers/249645 "2004-06-10T15:05:04Z")\ **Posts on this page:** 9\ **Page:** 1
**Author:** ![biddee](https://avatars.discourse-cdn.com/v4/letter/b/839c29/32.png) [@biddee](https://boards.straightdope.com/u/biddee)\ **Post date:** [June 10, 2004, 3:05pm UTC](https://boards.straightdope.com/t/fda-warns-against-use-of-domperidone-by-nursing-mothers/249645/1 "2004-06-10T15:05:04Z")
> [@](#): > > June 7, 2004 | WASHINGTON (AP) – The government is warning breast-feeding women not to use a drug called domperidone to increase their milk production, saying it not only is illegal but could harm both mother and child. > > The Food and Drug Administration cracked down on the drug Monday, moving to end imports and ordering several companies to quit making or distributing it here. > > The concern: There are reports of serious side effects among adult users, and domperidone is excreted in breast milk. > > Domperidone has never been approved for sale in the United States, but is used in some countries to treat certain stomach disorders. > A side effect is stimulation of a breast milk-producing hormone – but no country has approved the drug’s use for lactation, and several require explicit warnings against use by breast-feeding mothers. > > Yet FDA fears domperidone use may be increasing among breast-feeding Americans. Women have long been able to order it from abroad via the Internet, but FDA recently discovered a few U.S. pharmacies providing “compounded” supplies – drugs that pharmacists brew up specially for certain customers. > > 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. [http://neonatal.ama.ttuhsc.edu/lact/html/fda\_warning\_on\_domperidone.html](http://neonatal.ama.ttuhsc.edu/lact/html/fda_warning_on_domperidone.html) According to Hale’s (bfing and drugs bible), domperidone taken orally is totally safe for mother and baby. There are suggestions that the FDA is cracking down on the importation of drugs from Canada and this has nothing to do with lactating women as they (the FDA) did not even consult any Lactation experts. There is also speculation that the formula industry has a hand in this. Did you know that the FDA does not test infant formula, all they ask is that the formula industry test it themselves and submit the results…don’t you love self-regulating industries :dubious: . I would love to get some Doper’s opinions on this. ---
**Author:** ![MsRobyn](https://avatars.discourse-cdn.com/v4/letter/m/90ced4/32.png) [@MsRobyn](https://boards.straightdope.com/u/MsRobyn)\ **Post date:** [June 10, 2004, 6:37pm UTC](https://boards.straightdope.com/t/fda-warns-against-use-of-domperidone-by-nursing-mothers/249645/2 "2004-06-10T18:37:24Z")
> [@biddee](#): > > [http://neonatal.ama.ttuhsc.edu/lact/html/fda\_warning\_on\_domperidone.html](http://neonatal.ama.ttuhsc.edu/lact/html/fda_warning_on_domperidone.html) > > According to Hale’s (bfing and drugs bible), domperidone taken orally is totally safe for mother and baby. > > There are suggestions that the FDA is cracking down on the importation of drugs from Canada and this has nothing to do with lactating women as they (the FDA) did not even consult any Lactation experts. There is also speculation that the formula industry has a hand in this. Did you know that the FDA does not test infant formula, all they ask is that the formula industry test it themselves and submit the results…don’t you love self-regulating industries :dubious: . > > I would love to get some Doper’s opinions on this. Speculation doesn’t wash in GD. If you have a cite for the formula industry’s interference, please give it. As far as testing drugs for safety, no drug is tested by the FDA itself. Drug companies conduct clinical trials, then submit their results to the FDA for approval. Even after the drug goes on the market, adverse reactions are monitored, and a drug manufacturer can either be required to add warnings (as Tylenol recently had to do when it was shown that it can cause liver damage in people who drink), or can be pulled off the market altogether. This can happen for any adverse reaction or side effect, if it’s deemed serious enough. That said, nursing mothers represent a small fraction of the American drug-using population. They also should take responsibility for themselves and educate themselves on the drugs they take, and what affect they can have on lactation and their baby. Sorry, but I don’t see the FDA banning drugs because of issues with a relatively small population. Robin ---
**Author:** ![Jackmannii](https://sea3.discourse-cdn.com/straightdope/user_avatar/boards.straightdope.com/jackmannii/32/311_2.png) [@Jackmannii](https://boards.straightdope.com/u/Jackmannii)\ **Post date:** [June 10, 2004, 10:19pm UTC](https://boards.straightdope.com/t/fda-warns-against-use-of-domperidone-by-nursing-mothers/249645/3 "2004-06-10T22:19:37Z")
> [@biddee](#): > > [http://neonatal.ama.ttuhsc.edu/lact/html/fda\_warning\_on\_domperidone.htmlThere](http://neonatal.ama.ttuhsc.edu/lact/html/fda_warning_on_domperidone.htmlThere) are suggestions that the FDA is cracking down on the importation of drugs from Canada and this has nothing to do with lactating women as they (the FDA) did not even consult any Lactation experts. There is also speculation that the formula industry has a hand in this. Did you know that the FDA does not test infant formula, all they ask is that the formula industry test it themselves and submit the results…don’t you love self-regulating industries :dubious: . > > I would love to get some Doper’s opinions on this. The “suggestions” and “speculation” do not add up to hard information. In case you missed this from the linked article: “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.” The FDA has a mission to ensure that drugs intended to treat a specific condition have been adequately tested, are effective as intended and have an acceptable risk/benefit profile. If domperidone turns out to meet these criteria it will be legally marketed in the United States. I am not impressed by sellers sneaking it in via the back door and then benefiting from claims of government harassment. The FDA has had a role for many years in blocking sale of dubious and dangerous drugs, both domestic and foreign. The most outstanding example is of a sedative used widely abroad, marketed as wonderfully safe for everyone, including expectant mothers. Despite various pressures, the FDA held up approval here, denying millions of people the opportunity to take the medication. That drug was thalidomide. ---
**Author:** ![BrainGlutton](https://avatars.discourse-cdn.com/v4/letter/b/82dd89/32.png) [@BrainGlutton](https://boards.straightdope.com/u/BrainGlutton)\ **Post date:** [June 11, 2004, 2:23am UTC](https://boards.straightdope.com/t/fda-warns-against-use-of-domperidone-by-nursing-mothers/249645/4 "2004-06-11T02:23:38Z")
[emily latella] Eh? What’s this I hear about telling nursing mothers they shouldn’t use Dom Perignon? If anybody has a right to glass of expensive champaigne, it’s a woman who just had a baby! [/emily latella] ---
**Author:** ![MsRobyn](https://avatars.discourse-cdn.com/v4/letter/m/90ced4/32.png) [@MsRobyn](https://boards.straightdope.com/u/MsRobyn)\ **Post date:** [June 11, 2004, 2:40am UTC](https://boards.straightdope.com/t/fda-warns-against-use-of-domperidone-by-nursing-mothers/249645/5 "2004-06-11T02:40:25Z")
> [@Jackmannii](#): > > The FDA has had a role for many years in blocking sale of dubious and dangerous drugs, both domestic and foreign. The most outstanding example is of a sedative used widely abroad, marketed as wonderfully safe for everyone, including expectant mothers. Despite various pressures, the FDA held up approval here, denying millions of people the opportunity to take the medication. > > That drug was thalidomide. Not to put too fine a point on things, but thalidomide does have some legitimate uses. It’s approved for a particular form of leprosy, but IIRC, it has off-label uses in other diseases. [Cite](http://www.fda.gov/cder/news/thalinfo/thalomid.htm). It was re-approved by the FDA in the United States, but users must agree to use at least two reliable forms of birth control; for example, women must use birth control pills AND an IUD, even if she is infertile, unless she’s had a hysterectomy or is at least two years postmenopausal. There is a specific protocol that doctors must follow to be eligible to even prescribe it. Robin ---
**Author:** ![Jackmannii](https://sea3.discourse-cdn.com/straightdope/user_avatar/boards.straightdope.com/jackmannii/32/311_2.png) [@Jackmannii](https://boards.straightdope.com/u/Jackmannii)\ **Post date:** [June 11, 2004, 4:20am UTC](https://boards.straightdope.com/t/fda-warns-against-use-of-domperidone-by-nursing-mothers/249645/6 "2004-06-11T04:20:12Z")
> [@MsRobyn](#): > > Not to put too fine a point on things, but thalidomide does have some legitimate uses. True. The fact that the drug eventually was found to have some value in a few unusual cases and may prove useful in others depending on the outcome of research, doesn’t change the fact that it 1) was originally mass-marketed decades ago as a popular sedative in Europe, and 2) its sale in the U.S. was blocked by that the Food and Drug Administration, saving thousands of babies from horrific birth defects. ---
**Author:** ![MsRobyn](https://avatars.discourse-cdn.com/v4/letter/m/90ced4/32.png) [@MsRobyn](https://boards.straightdope.com/u/MsRobyn)\ **Post date:** [June 11, 2004, 11:10am UTC](https://boards.straightdope.com/t/fda-warns-against-use-of-domperidone-by-nursing-mothers/249645/7 "2004-06-11T11:10:02Z")
> [@Jackmannii](#): > > True. > > The fact that the drug eventually was found to have some value in a few unusual cases and may prove useful in others depending on the outcome of research, doesn’t change the fact that it 1) was originally mass-marketed decades ago as a popular sedative in Europe, and 2) its sale in the U.S. was blocked by that the Food and Drug Administration, saving thousands of babies from horrific birth defects. I know, and you made your point well. I was just enlightening our Listeners at Home that thalidomide isn’t some monster drug. Another good example is the FDA’s recent ban on ephedra. Robin ---
**Author:** ![Guinastasia](https://sea3.discourse-cdn.com/straightdope/user_avatar/boards.straightdope.com/guinastasia/32/5751_2.png) [@Guinastasia](https://boards.straightdope.com/u/Guinastasia)\ **Post date:** [June 11, 2004, 9:57pm UTC](https://boards.straightdope.com/t/fda-warns-against-use-of-domperidone-by-nursing-mothers/249645/8 "2004-06-11T21:57:12Z")
> [@Jackmannii](#): > > True. > > The fact that the drug eventually was found to have some value in a few unusual cases and may prove useful in others depending on the outcome of research, doesn’t change the fact that it 1) was originally mass-marketed decades ago as a popular sedative in Europe, and 2) its sale in the U.S. was blocked by that the Food and Drug Administration, saving thousands of babies from horrific birth defects. I thought it was marketed as a drug to treat morning sickness? ---
**Author:** ![Jackmannii](https://sea3.discourse-cdn.com/straightdope/user_avatar/boards.straightdope.com/jackmannii/32/311_2.png) [@Jackmannii](https://boards.straightdope.com/u/Jackmannii)\ **Post date:** [June 11, 2004, 10:58pm UTC](https://boards.straightdope.com/t/fda-warns-against-use-of-domperidone-by-nursing-mothers/249645/9 "2004-06-11T22:58:45Z")
> [@Guinastasia](#): > > I thought it was marketed as a drug to treat morning sickness? Thalidomide was also sold as an anti-nausea agent. Perhaps its greatest appeal was as a “safe” sedative and alternative to barbiturates, since you supposedly couldn’t fatally overdose on it. _“Another good example is the FDA’s recent ban on ephedra.”_ The ephedra ban can be seen as a good example of various things, depending on one’s point of view. For some, it’s an example of the government trampling on an individual’s right to freely buy and take a drug which is _really_ safe, if one is an intelligent user who would never ever abuse it and after all, those strokes and other serious complications just happen to _other_ people who are not as smart.\* For others, it’s an example of the FDA moving too slowly to prevent unnecessary deaths and injuries at the hands of mass marketers, who sold a drug that has never been shown to be effective for long-term weight loss. \*This can be summarized as the “Wildest Bill Philosophy”.