Concerns About Safety, Benefits of Breastfeeding Drugs
August 8, 2012 — Reglan and Domperidone, two drugs that are intended to treat stomach aches, are also two of the most popular drugs used for breastfeeding. Lactation specialists who promote the drugs claim they increase the production of a hormone called prolactin, which stimulates breast-milk production. Unfortunately, Reglan and Domperidone have not been approved by the U.S. Food and Drug Administration (FDA) for breastfeeding, the studies backing up their efficacy are weak, and the drugs have been linked to serious side effects — including cardiac disorders, depression, and a permanent muscle-twitching disorder.
The FDA warned about the dangers of Domperidone in 2004. The drug is not approved for any purpose in the United States, but it is available in Canada, and the FDA was concerned about women purchasing the drug internationally or through online pharmacies. The label on Domperidone specifically warns against using it for breastfeeding due to the risk of side effects (cardiac arrhythmias, cardiac arrest, and sudden death when it is given intravenously) and also because the drug is excreted in breast-milk, where it could potentially harm an infant.
The FDA has also warned about the dangers of Reglan. In 2009, the agency ordered a Black Box — the strongest warning — due to the risk of tardive dyskinesia. This disorder causes sudden, involuntary, and repetitive muscle movements, including blinking, eye twitching, tongue protrusion, grimacing, lip smacking, and weak finger movements. There is no effective treatment for the condition, and it could be permanent. Women who used Reglan for long periods of time were most likely to suffer from tardive dyskinesia.
Studies backing up the efficacy of Reglan or Domperidone are also weak. Because the FDA has never approved the drugs for breastfeeding, drug manufacturers have not been required to conduct well-controlled, randomized clinical trials to test their safety or effectiveness for breast-milk production. The American Academy of Breastfeeding Medicine published a study in 2011 that found no evidence linking the drugs to an increase in prolactin or a higher volume of breast-milk production.
The information comes as public pressure increases on women to breastfeed their infants. The World Health Organization (WHO) and the American Academy of Pediatrics recommends babies be fed exclusively breast-milk for six months. A June 2012 study published in Pediatrics found that many women fall short of their personal goals for breastfeeding — although 85% of new mothers intended to breastfeed exclusively for at least three months, only 32% actually accomplished this goal. Furthermore, 40% of new mothers breastfed exclusively for less than one month.
Mayor Michael Bloomberg of New York City has started a public health campaign to advocate breastfeeding, with subway advertisements and bans on distributing formula samples in hospitals.
Experts have found that breast-milk prevents illnesses and infections in a newborn. In the first few days after birth, the breast produces a thick yellow substance called colostrum, which contains the antibodies and nutrients a newborn needs. This changes to “mature” breast-milk, which is thinner and contains exactly the right amount of fat, sugar, water, and protein that a baby needs to thrive.
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