Since our February 2004 review of domperidone ¹, the US FDA has been busy dissuading patients and pharmacists who take or dispense domperidone to boost a mother's diminished milk supply. ² Leaders in the lactation medicine community consider the FDA's actions and opinions to be dubious and unconvincing. ^3,4 We agree with these criticisms and stand by our earlier endorsement of domperidone. Never-the-less, there are genuine legal complications facing patients, physicians and pharmacists who use domperidone as a galactogogue.

To dispense domperidone, a pharmacist must compound it from domperidone powder. This powder is commercially available as a raw chemical. This chemical is legal in the US. Its use in humans is not. It is thus bought and sold without any labeling describing its appropriate use in humans. This, technically, violates labeling requirements of the federal Food, Drug, and Cosmetic Act. It also means that this chemical, manufactured for use in a chemistry laboratory, of unknown purity and sterility, is the only source of domperidone in the US. Furthermore, domperidone has no official USP monograph and thus, technically, no standard exists for its appropriate preparation for use as a human drug. Finally, because domperidone is not approved for any use by the FDA, it is, technically, a new drug and can not be introduced into interstate commerce.

This all means that the pharmacist choosing to dispense domperidone is at risk of regulatory action. FDA-initiated regulatory action against a pharmacist or pharmacy may include issuing a warning letter, seizure, injunction, and/or prosecution. ⁵ To date, we are only aware of warning letters having been sent to a handful of pharmacies known by the FDA to be dispensing domperidone. The agency has warned these pharmacies that they could take more action against them but are choosing not to at this time. In addition to regulatory risk, the pharmacist who dispenses domperidone may also be in breach of the standards of pharmacy practice. Violation of the law is a de facto breach. If a patient were harmed from some dispensed domperidone, the pharmacist would be exposed to significant risk of professional negligence liability. As such, not every pharmacist may be willing to dispense domperidone.

It appears the FDA is currently not pursuing pharmacists or pharmacies who compound and dispense domperidone as long as they:

1. Are not engaged in interstate (web) commerce of domperidone and,
2. Can document that the physician and patient are using compounded domperidone as a "last resort" after having tried supportive measures and approved drugs, or if approved drugs are contraindicated.

While this anecdotal lack of FDA enforcement may seem like good news, there are state regulators who might not be so

What is a physician to do? Because of the legal risks, a steady supply of pharmacy-compounded domperidone in the US is not assured. A pharmacy that is taking the chance and dispensing domperidone this week may change their mind the next. Finding a pharmacy will always be a challenge every time a new patient presents with diminished milk supply and domperidone is indicated. For now, the domperidone sources listed on the SDCBC's fact sheet ⁶ are reliable. Prescribers should consider contacting the Professional Compounding Centers of America⁷ for recommendations on finding a pharmacy in their area who may be able to compound domperidone.

Advising the patient to purchase domperidone from pharmacies in other countries (either via the web or through travel to Canada or Mexico) is another option, but one which may also be short lived as the FDA continues to get tough⁸ on illegal medication imports. The agency has issued alerts⁹ to its field personnel regarding the specific importation of domperidone.

To conclude, the supply of domperidone can be as diminished as the breastmilk supply it treats. While this may be a discouraging reality, the drug is still inexpensive and somewhat available. We encourage lactation physicians and consultants to maintain market demand for domperidone but to plan ahead and locate a source convenient to the patient prior to prescribing. In this way, prescribing domperidone is not unlike prescribing a hospital-grade breast pump for outpatient use to mothers with MediCaid. Both of these treatment decisions are met by regulatory and market roadblocks that can negatively effect lactation success.

References:

1. Sauberan J, Wight NE, February 2004
2. FDA Talk Paper, June 7, 2004
3. Thomas Hale PhD, Christina Smillie MD
4. Jack Newman, MD, FRCPC
5. Guidance for FDA Staff and Industry, Compliance Policy Guides Manual, Sec. 460.200: Pharmacy Compounding
6. SDCBC Domperidone Fact Sheet
7. Professional Compounding Centers of America
8. FDA News December 1, 2004
9. FDA Import Alert # 61-07, 6-7-04

James G. Murphy, MD, trained in general pediatrics at the Naval Medical Center, San Diego, had the honor of serving as a Naval Medical Officer for 25 yrs retiring in 1995, and continues to serve as a General Pediatrician and Level 1&2 Nursery Attending at NMC San Diego. Dr Murphy maintains a special interest in immunization science and practice and promotion of breastfeeding, as a board member of the SDCBC.

The herb, Fenugreek, also known as Greek Hay or Greek Hay Seed, has been used since Biblical times to increase the production of milk for nursing and has been used safely for these thousands of years as a common ingredient of curry. More recently it is the main ingredient in imitation Maple Syrup and causes the urine and sweat to smell like Maple Syrup. Studies are currently underway to define the nature of this galactogogue effect. Until these studies are published, the only available information is from the experience of practitioners of various medical disciplines. Anecdotal evidence abounds of nursing mothers who had minimal milk supply until beginning Fenugreek then suddenly became engorged. Not everyone responds this way and side effects of nausea and GI distress in some appear to be dose dependent and may limit its use. The seeds of the plant are dried, ground and put into capsules of 500 mg to 610 mg available from a variety of web pharmacies and herbal stores. As the FDA does not monitor this herbal supplement, there are no true standards for measuring the actual amount of active ingredients in each brand of Fenugreek nor any guarantee of purity (absence of harmful contaminants). For this reason, authors recommend purchasing only from well-known reputable sources. Typically a bottle of 100 capsules costs $6-8 US.

The amount needed to effectively increase lactation in those for whom it is effective is 1000-5500 mg per day averaging 2 capsules three times per day. It has been suggested that when the mother's urine has clearly detectable Maple Syrup odor, this is the right dose and an increase in milk supply will occur within 2 days. Some authors note that milk flow, once established, can be maintained by frequent nursing and pumping without continuing the herb, while others note a decrease in the milk supply when the dose is reduced. This is apparently an individual response determined by trial and error. Only the dried seed in capsule form has been effective

References:

1. Herbs and Breastfeeding, Ruth A. Lawarence, MD www.breastfeding.comreading_room/herbs.html
2. Baylor College of Medicine www.bcm.edu/cnrc/consumer/archives/fenugreek.htm
3. www.divine-herbs.com/id23.html
4. Up To Date at www.utdol.com