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©iStockphoto.com/onebluelight
by Mary Jessica Hammes
January 31, 2010
Stephanie Sanders and Alex Bligh both had trouble with their milk supply in their early weeks of breastfeeding. After trying everything else, both turned to a drug called domperidone and found their supply quickly increased. Both were able to continue breastfeeding their children.
The difference? Alex lives in Dunedin, New Zealand, where she got a prescription from her doctor and had it filled at the pharmacy. Stephanie lives in northeast Georgia and had to sneak around, ordering her supply from the internet—from a company in New Zealand. The pills subtly arrived in an unmarked box.
FDA: Not okay
Stephanie and other American women wanting to take domperidone must go to international outlets online because in 2004 the U.S. Food and Drug Administration issued a warning against the drug, effectively making it impossible to buy it in the U.S.
Domperidone is an antidopaminergic drug, which means it blocks dopamine receptors and helps suppress nausea and vomiting. Since prolactin is inhibited by dopamine, domperidone stimulates lactation and can boost the milk supply of mothers having trouble breastfeeding, though it’s generally seen as a last resort solution.
A new study conducted in Canada and published in the January issue of Pediatrics found that domperidone increased breast milk supply for women who gave birth prematurely, without altering the milk’s nutrient composition.
The American Academy of Pediatrics lists domperidone as a “maternal medication usually compatible with breastfeeding” and notes that there is no “reported sign or symptom in infant or effect on lactation” (other than increasing lactation, one would presume).
Developed by Belgian-based Janssen Pharmaceutica, which is part of Johnson & Johnson, domperidone is available by prescription in a handful of countries, including Canada, and over-the-counter in over a dozen other counties, including the U.K., Japan, and Switzerland.
So what’s the big deal?
In a 2004 conference call, the FDA listed five reasons for concern:
The FDA also mentions the specific risks of cardiac arrhythmias, cardiac arrest and sudden death, although those risks are associated with intravenous use of the drug, while breastfeeding mothers would take it orally. “Because of the possibility of serious adverse effects,” reads the transcript of the 2004 conference call, “The FDA recommends that breastfeeding women not use domperidone to increase milk production.”
The FDA reinforces its position on its MedWatch page. “The FDA took these actions because it has become aware that some women are purchasing this drug from compounding pharmacies and from foreign sources,” the statement reads. “Although domperidone is approved in several countries outside the U.S. to treat certain gastric disorders, it is not approved in any country, including the U.S., for enhancing breast milk production in lactating women and is also not approved in the U.S. for any indication.”
Protection or politics?
The response from the breastfeeding community was quick. Some domperidone supporters suggested the FDA was less concerned about safety and more interested in controlling imported drugs, as reported by The Washington Post.
At the time, prominent physicians released their own statements. “The FDA’s statement regarding domperidone is based on specious reasoning, bad science and their continued ignorance of the dangers of not strongly supporting breastfeeding,” says Jay Gordon, an American physician and International Board Certified Lactation Consultant. “Most experts agree that domperidone is not only safe and effective but is still legal in spite of the warning from the FDA.”
“The FDA has basically come up with a political statement,” says Jack Newman, a Canadian pediatrician and author. “They seem really ticked off because people were going around using a drug which they have not approved. The deaths (and I believe there were two) occurred with intravenous domperidone, which is never used anymore and has never been used for enhancing milk supply. It is likely that if this drug was given intravenously, that the patients were sick with other problems as well, a confounding variable. Furthermore, unlike what the FDA has led people to believe, perhaps unintentionally, these are not new cases, but two decades old…. I will continue to prescribe domperidone to women when I feel it will be useful. It’s a shame, though, for women in the U.S. to be deprived of this drug.”
Stories of success
Both Alex and Stephanie said they do not regret taking the drug. In Georgia, Sanders, the mother of two and a part-time speech therapist, had a difficult time nursing her older child, now 4 years old. A blister on her nipple nearly became infected, and she had to temporarily breastfeed on only one side. Her body didn’t adjust as she had hoped, and she soon spent all her spare time pumping and taking fenugreek and blessed thistle (and supplementing with breast milk donated by a close friend who was nursing a baby the same age).
When her injured breast healed, she went back to breastfeeding on both sides, but still had trouble. Nothing seemed to work at all, but then—after a lot of research—she took domperidone. “I saw a pretty dramatic increase in two days,” she said. She took the drug from the time her son was 2 months old until he was 8 months old. “I’m relatively mainstream,” Sanders says. “I’m not incredibly rebellious against medical advice.”
But she knew she didn’t want to take Reglan, a trade name of metoclopramide, a legal drug that increases milk supply. Reglan crosses the blood-brain barrier (domperidone does not) and she knew some people “who had horrible experiences with Reglan and depression.” (Indeed, depression is listed as a rare side effect of Reglan.) She never told her pediatrician that she was taking domperidone, and while she planned to inform her own physicians if necessary, she never had an opportunity. “I felt completely confident the whole time I was taking it, not like I was doing anything wrong,” she says.
Meanwhile, in Dunedin, no one thought Alex was doing anything wrong; in fact, both her midwife and doctor recommended that she take the drug. The early days of breastfeeding were “basically a nightmare,” said Bligh, the mother of a 9-month-old daughter and part-time criminal and family lawyer. After watching her daughter lose substantial weight, pumping her breasts until she cried, addressing her daughter’s latch issues, finger-feeding and topping off with formula, she finally turned to domperidone.
“I was determined to breastfeed,” she says. ”It seemed to be the only option. It worked extremely well—definitely saw an increase after a couple of weeks, and I no longer had to top up with formula.” At the time, her daughter was 5 weeks old. For six months Alex took nine pills a day, then dropped to eight, and after a few weeks of her baby eating solid foods, Alex dropped to just one pill a day, which she still takes.
She was initially worried about side effects but felt reassured after researching. “It was a last resort but a necessary one,” she says. “The only side effects that I could see were that I became a little dehydrated. I think the bonding and benefits that come with breastfeeding outweigh the risks that domperidone may pose.”
These may be only two isolated cases, but given that the Canadian study found a 267 percent increase in milk production among mothers taking domperidone compared to 18 percent in those taking a placebo, perhaps it’s time for the FDA to rethink its position. What could be more protectionist than providing mothers with safe access to an effective drug?
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