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... |
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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 http://www.evalillian.com/LowSupply.aspx for more information on how this works). Domperidone is not available by prescription in the US, as it is not FDA approved.
The story goes that it costs many 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 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.
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, at least in her case, 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.
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. Dr Hale classifies Domperidone as the safest level of drug available for use while breastfeeding.)
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. http://www.evalillian.com/domperidone-jack-newman.html 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. http://www.kellymom.com/health/meds/aap- approved-meds.html 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
At the moment, I do not know what can be done about this matter, or if it will truly affect importations from Global Drug in New Zealand. I wrote to Global Drug to ask their opinion and experience on this development. They believe this is a scare tactic by our government to prevent importation of prescriptions from other countries, especially Canada. They do not expect it to effect their importation of the drug to the US.
I urge you to write to your congressional representative and the FDA itself. Contact information is below.
Submit your comments to the FDA http://www.fda.gov/cder/comment.htm
Write to the FDA:
Commissioner US Food and Drug Administration Dockets Management: Branch Room 1-23 12420 Parklawn Dr. Rockville, MD 20857
Write your Congressperson here http://congress.org/congressorg/dbq/officials/?lvl=L
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.
Jessica Hudson is owner of Eva Lillian Maternity & Nursing Boutique. She is an avid researcher, breastfeeding mother, and all-things-baby romantic. To receive monthly coupons and more articles like this, sign up to receive our newsletter.
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