Breastfeedingoutlook.com

Reprinted from Issue 2 • 2004
Editorial
Domperidone Warning: Important
or Importation?
Here you have it! The perfect example of how profits and politics influence health care. The recent statements from the Food and Drug Administration (FDA) about domperidone are so obviously motivated by politics and profits that the potential impact on health takes a back seat. (See related article page 6.) On June 7th, the FDA issued a warning to women, a warning letter to six pharmacies that compound the drug, and an Import Alert. Keep your eye on the politics of that third document, the Import Alert, while I explain particulars of the other two.
The Talk Paper issued by the FDA warned women that purchasing this drug from compounding pharmacies and foreign-country sources poses a health risk. The paper states that published reports and case studies have demonstrated that patients who have received the IV dosage form have experienced cardiac arrhythmias, cardiac arrest, and sudden death. They go on to say that the oral form is excreted in the mother’s milk.
Whoa! First, I guess they assumed that mothers wouldn’t be smart enough to know that the IV form of the drug, which is 100% absorbed into the maternal circulation, would not have the same adverse effects as the oral form, which is only partially absorbed. (Since the IV form of KCl has side effects, will the FDA ban the oral dose, or Lite Salt which is half KCl? Of course not.) Second, without explicitly citing the studies to which they refer, the lay public, as well as the professional providers, have no way to verify The FDA points out that in countries where the oral form is available, the product carries a warning label that the drug is excreted in milk and could therefore expose a breastfeeding infant to unknown risks. True enough. Like nearly every other drug that has ever been manufactured, domperidone is excreted in the mother’s milk. And, until trials of every drug are conducted on populations of breastfeeding mothers, many will continue to have “unknown” risks. If you’ve bought as many prescription and over-the- counter drugs as I and my family have, you’ve probably noticed that many if not most medications carry a warning label that the drug should not be taken by breastfeeding mothers. So the excretion, the unknown risks, and the warning label would make domperidone different from other drugs sold in America…how? Interestingly, the FDA warned about the side effects of domperidone but not metoclopramide, a similar drug with well-known and widely-reported severe side effects from the oral preparation. But don’t worry. They’re the government, They’re here to take care of The Import Alert exposes the kingpin that steers this issue into a profitable direction. The FDA issued all of the recent domperidone-related documents 12 days after California approved legislation for a state-run web site that would help Californians to purchase drugs from Canada. There is strong speculation that other states will now do the same. The FDA has long opposed the importation of drugs. The pharmaceutical industry has long lobbied against it in order to retain its average of 24% profit margin. Might there have been a little pressure here? Buyer, beware. Don’t mistakenly conclude that this hullabaloo is about protecting babies or sabotaging breastfeeding efforts. This is www.breastfeedingoutlook.com

Source: http://www.breastfeedingoutlook.com/documents/editorials/2004.2-domperidone.pdf