Despite its excellent reputation for lactation and gastrointestinal (digestive problems) purposes, the use of domperidone has become a subject of controversy in the US, where it has not been through the FDA review process and therefore is not commercially available. Many patients with gastritis who are unresponsive to US-approved medications have quietly been obtaining domperidone from local compounding pharmacies or outside of the country for years. More recently, as the apparent safety and efficacy of domperidone for increasing milk production has spread among US mothers and professionals, its popularity has surged.
In the summer of 2004, the FDA became aware of the fact that domperidone was being obtained by breastfeeding mothers both from out of the country and by prescription from compounding pharmacies, and issued a statement of warning to physicians and consumers. Their stated concerns were three-fold: Public health risks based on cardiac problems with intravenous use of domperidone; passage of the drug into human milk; and labeled warnings on bottles from other countries that the drug should not be used by breastfeeding women. The FDA also took the added step of issuing warning letters to six compounding pharmacies.(1)
In a statement in May of 2005, the FDA acknowledged that domperidone is a beneficial drug for the treatment of severe gastrointestinal disorders and suggested that physicians who wish to prescribe it for their patients with gastrointestinal disorders submit an application for FDA authorization. However, it reiterated its position against domperidone use for increasing human milk based on the fact that domperidone transfers into the milk that the baby will be drinking (most drugs do pass into the milk, usually in insignificant amounts). It is interesting to note that the FDA has not expressed any similar concerns with the use of metoclopramide, a similar drug with more serious potential side-effects, in breastfeeding mothers.
Critics of the FDA statement are numerous. The Canadian Medical Journal published a response to the FDA’s statement in September of 2004, noting that the adverse reports occurred in a population undergoing cancer therapy with an IV form of therapy that is no longer used. Their only recommended caution was for women who have a history of cardiac problems.(2) Dr. Tom Hale, pharmacist and author of Medications in Mothers Milk, wrote to the FDA about his concern that the citations they used were inappropriate and old, and that they ignored the many more recent years of successful use of the oral form of the medication.(3) Dr. Christina Smillie, a physician who practices lactation medicine, wrote to the FDA of her objections to their statement regarding warnings on the manufacturer’s labeling for domperidone. She noted that such statements are ubiquitous legal disclaimers commonly found on nearly all medications, including those that are considered compatible with breastfeeding, and that they are written for legal reasons and are not substantiated by research.(4) Indeed, domperidone is considered to be safe and effective by the regulatory agencies of the European countries and is available without prescription in many countries, including Ireland, Italy, Netherlands, China, South Africa, Mexico, New Zealand and Chile.
On May 28, 2006, a US Federal Judge ruled that the FDA cannot prohibit compounding pharmacies from filling prescriptions issued by US doctors. **This means it is absolutely legal for a US physician to write a presciption for domperidone and for a US compounding pharmacy to fill it.**
Here are links to more information about the controversy: