FDA Warning on Domperidone
The Food and Drug Administration called yesterday to inform me of their decision to issue a warning on the use of domperidone in breastfeeding mothers. They stated that they became concerned after the publication of several case reports of domperidone toxicity following high dose "intravenous" domperidone in some patients.
Unfortunately, the correlation of intravenous administration with oral administration of domperidone is simply ludicrous. Domperidone is only 13-17% bioavailable orally. Peak plasma levels in recipients following 20 mg orally is only 15-18 ng/ml. Peak plasma levels following a 10 mg intravenous dose is reported to be 1200 ng/ml, almost 80-150 fold more than oral administration. I don't really see how high doses intravenously even correlate with the use of low to moderate doses orally in breastfeeding mothers.
They also stated that the data on the use of domperidone in breastfeeding mothers was limited, improperly designed, and did not give a good estimate of the transfer into human milk, or to the infant. While I agree that the data on domperidone is somewhat limited, these complaints could be used with virtually every other drug we have on the US market today, including all the anti-asthma products, analgesics, antidepressants, and dozens of commonly used drugs. Why hasn't the FDA issued warning on Advair, morphine, Reglan, Demerol, or Prozac. We certainly haven't stopped using all these drugs because of limited data in breastfeeding mothers.
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.
When I asked them if they had consulted with anyone in the field of human lactation about the consequences of this action, they had not. When I asked them what breastfeeding mothers were to do, they answered contact their physician for options, or switch to formula.
I do not propose to advise you as to what you should do, but as for me, I simply choose to ignore them, and their advice.
Thomas W. Hale, R.Ph., Ph.D.
Professor of Pediatrics