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Domperidone and the FDA Controversyby Jessica Hudson Owner of Eva Lillian Maternity & Nursing Boutique, 2004 |
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Domperidone is a prescription
drug used for treating reflux.
It has the fortunate side effect
of increasing prolactin in
lactating women, thus increasing
milk supply (see our
article
on low milk supply for more
information). Domperidone
is not available by prescription
in the US, as it is not FDA
approved. The story goes that it costs literally millions of dollars to push something through the FDA's approval process. And since there is already an adequate FDA approved drug (Reglan) for the intended purpose (treating reflux), no one is willing to spend the money on the approval of Domperidone. However, Domperidone is widely used in other countries, including Canada, under the brand name Motilium. |
| Recently (Summer 2004) the FDA released a statement expressing its "concern" over the use of the drug Domperidone by nursing mothers. The agency is drawing a weak link between a tiny sample of studies on intravenous application of the drug in adults (resulting in a tremendously higher dose than that taken by a nursing mother) and some resulting terrible, sometimes fatal, side effects. Because of their concerns, they have ordered compounding pharmacies (the only source of the drug in the United States) to stop making the drug, and banning all future importations from outside countries. |
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As a
nursing mother reliant on
domperidone in order to feed my
children, I am appalled and
saddened by the stance taken by
the FDA, on the heels of the
launch of the National
Breastfeeding Awareness Ad
Campaign. It has been
speculated that politics and
money are driving this decision,
and I do not disagree. I
just thank the powers that be
that I imported my year's supply
of the drug before the ban, or
my dairy and soy allergic baby
would be strong-armed into
unbelievable digestive problems
and a lifetime of goodness knows
what kind of difficulties by
being forced to switch to
incredibly inferior and
downright harmful hypoallergenic
formula.
Gone would be the wonderful bond with my daughter. Gone would be my dreams of extended breastfeeding my child for the next 2 years or so. Gone would be her health, her immune system (hello further allergies!) and her main source of comfort. It makes me sick to think of how many women out there, blindly trusting the power of a far from omnipotent government agency, are weaning their sweet little babies this very moment, believing they have done them some harm by using Domperidone until now, and no longer able to nurse without it. The tears are welling up as I type. |
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Read the FDA's Warning here.
The announcement comes just after a delay of the National Breastfeeding Awareness Campaign by formula companies. Read more here. And read 20/20's news story about the "battle between Mother's Milk and corporate power" here.
Read Dr. Hale's response here. (Dr. Hale writes the physician's resource for drug use and safety during lactation, Medications and Mothers' Milk. He is the recognized authority in the nation, possibly the world, on the subject. Ask your pharmacist or doctor if something is safe while breastfeeding, and she will consult Dr. Hale's book.) Here is an excerpt: "Unfortunately, the correlation of intravenous administration with oral administration of Domperidone is simply ludicrous...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."
Read Dr. Jack Newman's handout on Domperidone. Dr. Jack Newman is one of the top recognized authorities on all things breastfeeding related in the US.
Domperidone is approved for use in breastfeeding mothers by the AAP (American Academy of Pediatrics). Reglan is not. Find the full list here. And find more info on the safety of each and the AAP's approval here.
Lastly, to put another nail in the coffin of the FDA on this matter, formula manufacturer Wyeth is also the manufacturer of Reglan, Domperidone's direct competitor in the US and the reason Domperidone has not been pushed through the FDA's system for approval. Wyeth apparently has a bad record as far as strong arm tactics: "The benchmark standards for measuring marketing practices are the International Code of Marketing of Breastmilk Substitutes and relevant World Health Assembly (WHA) resolutions...Wyeth has had a few brushes with national authorities on code matters." http://www.ibfan.org/english/pdfs/btr04summary.pdf I urge you to write to your congressional representative and the FDA itself. Contact information is below. |
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Submit your comments to the FDA Write to the FDA: Commissioner Select your state, select View under Congressional Delegation, select your Senate or House Member, select Send Message on the left of the screen under the congressperson's photo, select the radio button for Compose Your Own Letter. For further information on this topic visit Mother2Mother Services at http://www.geocities.com/mother2motherservices/index.html Update 8/10/04: After posting this article I received an email from a motility patient. I'd never even heard of such a condition, but the name Motilium (domperidone's brand name) obviously had something familiar about it. I learned that these people have such severe stomach problems they are literally unable to eat. Many require tubes to feed predigested liquids directly to their intestines just to be able to survive. Some of these people are able to exist (meaning not lose so much weight that they are confined to a hospital bed until they eventually just waste away) by taking domperidone. It is the only thing that allows them to take in even semi-solid foods to maintain some semblance of their health. They are also no longer able to obtain this drug from compounding pharmacies in the US and are facing the possibility of not being able to import it "under the radar". In this case we are truly talking about people's lives that the FDA is endangering. Please write everyone you can think of to express your feelings on this assault on our lives. |
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