Domperidone and the Current FDA Controversy
by Jessica Hudson
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.
http://www.fda.gov/bbs/topics/ANSWERS/2004/ANS01292.html
The announcement comes just after a delay of the National
Breastfeeding Awareness Campaign by formula companies. Read
more here.
http://www.wcpo.com/news/2004/local/06/04/adcampaign.html
And read 20/20′s news story about the “battle between
Mother’s Milk and corporate power” here.
http://www.abcnews.go.com/sections/2020/Investigation/2020_breastfeedi ng_ads_040604-1.html
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This entry was posted on Thursday, June 24th, 2004 at Thursday - June 24, 2004 and is filed under General Health, Health News.