Lactation Supression: Safer Without Drugs

by Food and Drug Administration (FDA)

Rosellen Bowen was having a tough time completing her master's thesis. The graduate nursing student was researching whether breast massage would help relieve the pain and discomfort some new mothers experience when they don't breast-feed their babies. But she had trouble finding participants.

During the year she worked on her thesis, over 3,000 babies were born at the University of Rochester Medical School Hospital, where she worked, and the Rochester Community Hospital. But out of the 800 women at these two hospitals who didn't breast-feed their babies, Bowen could only find 46 who said they felt pain when their breasts filled up with milk.

Determining pain is subjective, experts say. But on a 10-point pain scale that Bowen provided for the participants, no mother, at any time, scored pain above a 6.

She had a lot of trouble completing her thesis with a valid number of patients because [pain] was not a common complaint, says Ruth Lawrence, M.D., a pediatrician who worked with Bowen.

Bowen found that although breast massage did help some new mothers, for most, the long-standing traditional treatment of pain relievers, ice packs, and a well-fitting bra or specially made breast binder was sufficient.

Because other studies have also shown that these traditional treatments provide enough help for the minority of women who do experience pain, and because the drugs used to suppress lactation carry risks, the Food and Drug Administration's Fertility and Maternal Health Drugs Advisory Committee recently recommended that drugs to prevent milk production not be used. Following the committee's recommendation, FDA has asked the manufacturers of these drugs to stop including lactation suppression as an approved use.

The major drug used for suppressing lactation is a non-hormonal substance called bromocriptine. It is also used to treat Parkinson's disease, but because this is a serious disease, the risks associated with the drug's use do not outweigh its benefits. The other lactation-suppressing products all contain the female sex hormone estrogen, alone or in combination with the hormone testosterone.

Sending a Message

Even when a woman knows long before her baby is born that she isn't going to breast-feed, her body needs a few non-breast-feeding days after the baby is born to get the message.

In the meantime, milk production begins. First, levels of the hormones estrogen and progesterone, which are very high during pregnancy, drop abruptly after birth. This drop signals another hormone, prolactin, to stimulate milk production in the breast. The milk is produced in cells throughout the breast and then travels through the milk ducts to the openings in the nipple. In a mother who breast-feeds, her baby's suckling signals the prolactin to keep the milk coming. But when a woman doesn't breast-feed her baby, the prolactin levels drop, and milk production ceases.

In the few days it takes before lactation stops, the mother's breasts can fill up with milk. For some non-nursing women, this engorgement is uncomfortable, and occasionally even painful.

Lactation suppression drugs prevent engorgement and, in fact, prevent lactation before it begins. The most commonly prescribed drug, bromocriptine, acts by cutting the production of prolactin. In contrast, the sex hormones keep the estrogen at pre-birth levels, tricking the body into thinking it is still pregnant.

Do They Work?

The National Academy of Sciences/National Research Council (NAS/NRC) reviewed the effectiveness of estrogens and androgens such as testosterone as lactation suppressants approximately 20 years ago as part of a review of all drugs approved before the 1962 drug amendments. (The amendments required, for the first time, that drugs must be effective as well as safe.)

NAS/NRC explained that it did not know of any satisfactory evidence that these drugs could effectively prevent lactation. Nevertheless, since the drugs were commonly used for lactation suppression, the panel decided the indication could be continued.

Evidence on the safety of the sex hormones for lactation suppression is also lacking. (Since the safety problems connected with other uses of these hormones had not surfaced in the 1950s, the indication was allowed at that time.) The risk of thromboembolism has been connected with estrogens used as oral contraceptives. But, according to FDA's Diane Wysowski, Ph.D., there is a paucity of good, definitive data on the acute and long-term effects of sex hormones used for prevention of postpartum breast engorgement. The bottom line is, nobody really knows.

The same uncertainty about safety and effectiveness surrounds bromocriptine. When FDA approved this drug for lactation suppression, clinical trials had not uncovered any serious side effects and the results of several studies showed that the majority of women given the drug did not experience engorgement. However, what was impossible to determine with these studies was whether engorgement was actually prevented. There is no way to predict whether a woman's breasts will become engorged or, if they do, whether the engorgement will cause pain.

In addition, even when bromocriptine seems to work, the drug's success may be short-lived. According to the official labeling, up to 40 percent of the time, rebound engorgement occurs after the two-week course of treatment with bromocriptine ends.

According to FDA's division of metabolism and endocrine drug products, bromocriptine has been associated with seizures, strokes, and heart attacks, but the connection has not been firmly established. What has been established are bromocriptine's less severe side effects nausea, dizziness, and drop in blood pressure.

Benefit vs. Risk

Based on several different studies, FDA estimates that only a very small minority of women given lactation suppressants may possibly benefit from the treatment. For the majority, taking the drug only exposes them to possible side effects. In August 1989, the Health Research Group, a consumer organization, requested action against the use of lactation suppressants. In its response, FDA said that because the drugs are not therapeutically required, any risks are unacceptable.

What about the side effects from doing nothing to stop milk from coming in The side effects of letting nature take its course breast engorgement, leakage, discomfort are short-lived, says Lisa Rarick, M.D., an obstetrician with FDA's division of metabolism and endocrine drug products. Doing nothing is 100 percent effective. It's an issue similar to any physiological problem that resolves on its own, like painful [menstrual] periods. When you have an adolescent come to your office and she hasn't had a period yet, you don't just automatically give her a prescription to prevent painful cramps. If somebody comes to you and she has the pain, then you treat her.

Where does that leave women who decide not to breast-feed? First, the symptoms can be treated by other means if they occur. According to the University of Rochester's Lawrence, who has written a book for physicians on all aspects of breast-feeding, nonprescription pain relievers such as acetaminophen seem to take care of women's discomforts. Only rarely is something [stronger] needed.

Second, except for two estrogen drugs that are only used for lactation suppression, all the other products will still be on the market. FDA does not regulate the practice of medicine. Physicians are free to use approved drugs in any way they feel is medically necessary.

Lawrence adds that the risks of letting lactation end naturally seem to be close to zero. I think in some respects we've assumed that women would rather be medicated than experience any discomfort at all, and that is probably not true.

About the Author

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