While the FDA remains convinced that domperidone is not safe for nursing mothers, many groups and individuals feel that the refusal to approve domperidone for lactation is more harmful than helpful, and some are even calling it discrimination.
The FDA has made it clear that it considers domperidone unsafe, especially for breastfeeding mothers. But what about pediatric groups, mothers, and breastfeeding activists? Why is it important to them that this drug gets FDA approval when there are other drugs out there intended for aiding lactation? Why do they feel that they are being targeted unfairly by the FDA?
Health Benefits of BreastfeedingThe Canadian Breastfeeding Foundation argues that the benefits of breastfeeding to both mother and infant outweigh the risks that are associated with taking domperidone. In the mother, breastfeeding decreases the risk of both breast caner and type 2 diabetes. In the baby, it decreases the risk of both types 1 and 2 diabetes, obesity, asthma and allergies, and many other health risks. As well, breastfeeding helps encourage mother-infant bonding and helps create healthy attachment.
Risks Exaggerated by FDAThe American Association of Pediatrics lists domperidone as compatible with breastfeeding, and claims that there is no effect on infants. Many others have argued that amount of domperidone in breast milk is so minimal that it does not affect breastfeeding infants.
According to the Canadian Medical Association Journal FDA warnings against the use of domperidone by breastfeeding women were based on the increased risk of cardiac arrhythmia and sudden death in patients receiving high doses of domperidone intravenously, along with chemotherapy. As well, of these patients, all those whose serum potassium level was measured had low levels.
As with any other drug, patients should be warned of the risk of cardiac arrhythmia, and lactating women with known cardiac issues should not use the drug. However, the studies done for domperidone are not large enough to convince some health providers of its danger, and some results cannot even be applied to this issue (e.g. studies based on high doses given intravenously, while lactating mothers are given smaller doses orally).
Unsatisfactory AlternativeMetoclopramide, a drug that has been used in the past to help stimulate lactation, had common side effects of depression, fatigue and irritability, which are not acceptable side effects for new mothers. The side effects of domperidone are generally less common and less severe than those experienced with metoclopramide.
For mothers who have tried all non-pharmacological ways to induce lactation, taking away the option of a drug could very well mean taking away the option of breastfeeding. The Canadian Medical Association recommends that mothers continue to keep the option of domperidone open, if they have tried all other options and if it is safe for them to do so.
There is not one right answer when it comes to breastfeeding, and studies of domperidone have not yet been conclusive enough to create agreement in the medical community. Domperidone is available through Canadian pharmacies, and there are many other options available without the need for a prescription. Talk to a doctor, a La Leche League counselor, a midwife or another knowledgeable health professional before making a decision.
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