Food and Drug Administration Warns Against The Use Of The Unapproved Drug Domperidone To Increase Milk Production

On June 7, 2004, the Food and Drug Administration (FDA) warned nursing women not to use the unapproved drug domperidone to increase breast milk production because of the risk of heart arrhythmia and cardiac arrest. Domperidone is approved in several countries outside the U.S. to treat certain gastric problems. It is not approved in any country, including the U.S., for enhancing breast milk production in lactating women and is not approved in the U.S. for any use.

At the same time the FDA issued the warning, the agency released warning letters addressed to four compounding pharmacies who make and sell domperidone and two suppliers of bulk domperidone to compounding pharmacies.

Because domperidone has never been approved for use in the U.S., the pharmacists preparing domperidone products are in violation of laws that have evolved over the past century to protect consumers. In addition, a U.S. physician importing domperidone from another country and selling it to nursing mothers to increase milk production is in violation of the law.

The pharmacies and suppliers cited by the FDA are:

Axium Healthcare Pharmacy
285 W. Central Parkway #1720
Altamonte Springs, FL 32714

Drugs Are Us, Inc. Doing Business As Hopewell Pharmacy
1 W. Broad Street
Hopewell , NJ 08525

Peoples Pharmacy, Inc.
3801 South Lamar Blvd., Ste. C
Austin, TX 78704

Line Avenue Pharmacy
1822 Line Avenue
Shreveport, Louisiana 71101

Professional Compounding Centers of America
9901 South Wilcrest Drive
Houston, TX 77099

Spectrum’ Chemicals & Laboratory Products
1422 South Pedro Street
Gardena, CA 90248

There are potential risks associated with the use of domperidone by nursing mothers. There have been several published reports and case studies of cardiac arrhythmias (heart rhythm disturbances), cardiac arrest (heart stoppage), and sudden death in patients receiving an intravenous form of domperidone that has been withdrawn from the market in a number of countries. In several countries where the oral form of domperidone continues to be available, labels for the drug contain specific warnings against use of domperidone by breastfeeding women, and note that the drug is excreted in breast milk and could expose a breastfeeding infant to unknown risks. Because of the possibility of serious adverse effects, the FDA recommends that breastfeeding women not use domperidone to increase milk production.

The evidence to support the use of domperidone to augment breast milk production is scant. Domperidone proponents generally point to a small study published in the January 9, 2001 issue of the Canadian Medical Association Journal in support of the drug’s use to increase milk production. The authors of this study commented that previous studies of domperidone had methodological shortcomings, including inappropriate control groups and no information on the blinding of subjects or the method of randomization, and that the infants were weighed before and after breastfeeding, an unreliable method at best to evaluate the effect of the drug.

This study involved 20 new mothers who had their babies admitted to a neonatal intensive care unit. Randomly, ten were assigned to take domperidone and ten a placebo. Milk production at the start of the study was higher in the domperidone group than in the placebo group. The study lasted only seven days.

Results from only 16 mothers were available for analysis at the end of the study, seven in the domperidone group and nine in the placebo group.

The authors concluded by saying:

Many questions need to be answered before domperidone can be routinely recommended to increase lactation. In particular, it is not known whether the short-term benefit of domperidone will be sustained. Also, the long-term effects of this drug on the infant, if any, need to be determined. A large multicentre trial should be conducted to address these questions.

We have serious reservations about the use of this, or any other drug, in what are, in fact, healthy young women. Although this drug is not approved in the U.S. for any use, in countries in which domperidone is approved to treat gastric problems, the unapproved use of the drug to augment milk production is referred to as an “off-label” use. We have written on many occasions about the dangers of off-label drug use.

A recent example of the potential dangers of off-label use was the unapproved use of hormone replacement treatment to protect postmenopausal women from heart attacks, strokes, and dementia. When the results of a very large government-sponsored trial were reported, the risks of hormone replacement clearly outweighed the benefits. The risks of heart attack, strokes, dementia, breast cancer, and blood clots in the lungs were all increased (see Worst Pills, Best Pills News September 2002 and March 2004).

The FDA said in their domperidone warning that:

The FDA recognizes the immense health benefits that breast milk provides for a nursing infant and is taking these actions today not to discourage women from breastfeeding but rather to warn them not to use this particular drug while they are breastfeeding.

We strongly agree with the above statement.

A number of compounding pharmacists are now disguising the small-scale manufacturing of unapproved new drugs, such as domperidone, outside the safety constraints of FDA-regulated Good Manufacturing Practices as being a “normal part of the practice of pharmacy.” The drugs these pharmacists make have not been shown to be safe and effective and are not FDA-approved. These pharmacists are simply making an end run around the FDA’s drug approval process for profit but making it seem as if it were a noble cause in the interests of patients.

What You Can Do

You should not use domperidone to increase breast milk production because of the known risks and unknown effectiveness.

Beware of compounding pharmacists promoting domperidone to increase breast milk production.