Inducing Lactation, Domperidone and the 2004 FDA Warning

Q: I plan to adopt a baby and have read about using the drug domperidone to induce lactation. There’s a lot of conflicting information on the web though, and I even read that the FDA has warned against breastfeeding mothers using the drug. What can you tell me about that warning?

A: Domperidone is an anti-nausea medication that also happens to increase serum prolactin in women. It’s used in combination with frequent nursing or pumping to induce lactation or increase milk supply.

Domperidone is readily available outside the United States but is not available through most pharmacies in the U.S. It’s not illegal though and women can order it with a doctor’s prescription through “compounding pharmacies” in the U.S. or without a prescription directly from pharmacies in other countries.

Dr. Jack Newman and lactation consultant (and adoptive mother) Lenore Goldfarb have developed three protocols for induced lactation: (1) the Regular Protocol for women who have six or more months before bringing a baby into the family, (2) the Accelerated Protocol for women with little time to prepare for arrival of the baby and for re-lactating women, and (3) the Menopause Protocol for women who are menopausal due to surgical removal of the reproductive organs or naturally occurring menopause. Each of these protocols involves taking domperidone.

In June 2004, the U.S. Food and Drug Administration issued a warning against the use or import of domperidone. A reading of the warning raises two concerns: (1) is domperidone safe, and (2) is it illegal to import it into the U.S.? The easy answer first–In spite of the harsh warning about importing the drug, Dr. Newman explains:

It is perfectly legal for a US doctor to prescribe domperidone even though it isn’t available in the US [see exception below]. Any Canadian pharmacy can send you domperidone if you get a prescription from your doctor. And it is legal for a US citizen to bring domperidone into the US for personal use provided it is accompanied by a doctor’s prescription, a letter stating that the medication is for the patient’s personal use, and the shipment does not exceed a 3 month supply.

Domperidone is also available from compounding pharmacies in the U.S. with a prescription, and countries other than the U.S. and Canada without a doctor’s prescription. According to Dr. Newman, a doctor’s prescription is not necessary to import the drug as long as the drug is not a controlled substance, it is for personal use, it does not exceed a three-month supply, and the patient lists the name and address of a doctor who will be overseeing the patient’s use of the medication.

As always, when a woman has questions about the safety of a particular medication, she should consult her doctor, do her homework and make an informed decision. The good news is that domperidone is approved by the American Academy of Pediatrics for use by breastfeeding mothers. Domperidone is listed as a medication “usually compatible with breastfeeding” and there are no reported signs or symptoms in the infant.

With respect to the FDA warning, the Breastfeeding Answer Book says:

Note: In June 2004, the US Food and Drug Administration (FDA) advised that domperidone should not be used by breastfeeding mothers. Members of the La Leche League International Health Advisory Council are questioning this.

In Thomas Hale Ph.D.’s Medications and Mothers’ Milk he has this to say about the FDA caution:

Recently the US FDA issued a warning on this product stating that it could induce arrhythmias in patients. These claims were derived from data many years old where domperidone was used intravenously as an antiemetic during cancer chemotherapy…. Many of these patients were undergoing extensive chemotherapy and were extremely ill, and hypokalemic to begin with. Further, intravenous domperidone produces plasma levels many times higher than oral use. Thus far, we do not have any recently published date suggesting that domperidone used orally in breastfeeding mothers is arrhythmogenic.

p. 278. Domperidone is also discussed on Dr. Hale’s medications forum.

Further drug information can be found by searching for “domperidone” in the LactMed database I wrote about here.