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We had planned to assess the cardiac safety of domperidone using a prevalent new-user design.24 However, given the small number of events in each province, this approach was deemed infeasible. Consequently, we estimated crude rate ratios and rate differences for each outcome across provinces, with exposure defined using the previously described time-varying approach.
Prevalence of domperidone use in the 6 months after delivery among postpartum patients in 5 Canadian provinces. Health Canada advisories regarding domperidone were issued in March 2012 and January 2015.
Interrupted time series analysis examining the impact of the 2012 Health Canada advisory on rates of initiation of domperidone in the 6 months immediately postpartum in 5 Canadian provinces. The dashed line represents the release of the 2012 Health Canada advisory. Note: CI = confidence interval.
Interrupted time series analysis examining the impact of the 2015 Health Canada advisory on rates of initiation of domperidone in the 6 months immediately postpartum in 4 Canadian provinces. Ontario was excluded from this analysis owing to insufficient data available post-advisory. The dashed line represents the release of the 2015 Health Canada advisory. Note: CI = confidence interval.
Appendix 1, Supplemental Tables 5 and 6 summarize the dosage and duration of the first domperidone treatment episode among initiators by province and by period. Overall, among those dispensed domperidone, the dosage decreased across periods in each province. However, the median dosage remained greater than 30 mg/d in all provinces after the advisories. The median duration was 30 days in most provinces, which remained unchanged after the advisories.
We observed interprovincial variation in domperidone prescriptions. These differences approximate the prevalence of breastfeeding during the study period,25,26 suggesting that differences in the prevalence of breastfeeding may be at least partially responsible for the observed interprovincial differences. Given our use of administrative data, we were unable to restrict inclusion to patients who were breastfeeding. Ultimately, the observed interprovincial differences are likely explained by a combination of differences in prescribing practices, health care access, patient preferences and breastfeeding practices.
The impact of regulatory warnings concerning domperidone has been examined previously outside of Canada.27 Mehrabadi and colleagues found that the EMA advisory regarding domperidone was associated with decreased prescribing of dosages greater than 30 mg/d, a nonsignificant decrease in monthly prescriptions and no change in time trend in the United Kingdom.27 Importantly, although the Health Canada advisories were followed by decreased rates of initiation at higher dosages and decreased median dosage in all provinces in our study, the median dosage in all provinces exceeded the recommended dosages of no more than 30 mg/d after the advisories.9,10
It has not been released in Canada for increasing milk supply, but this does not mean it cannot be prescribed for this reason. There are many studies that show that domperidone works to increase milk supply and is generally very safe to use.
Taking domperidone on an empty stomach does allow it to be better absorbed, but it is not necessary to do this for it to work to increase breastmilk production. Spread the doses out throughout the day and take it when it is most convenient for you. Mothers do not have time to make sure they take the domperidone at exactly such and such time.
As with all medications, side effects are possible. There is no such thing as a drug that has no side effects. However, in our clinical experience, side effects in the breastfeeding mother are very uncommon. Some mothers may experience headache (usually mild), dry mouth, abdominal cramps, weight gain/increased appetite, and alteration of menstrual periods (usually stopping them, if they have resumed; breakthrough bleeding is also possible). Most of those who experience side effects find they disappear after a few days to a week of starting the domperidone.
The amount of domperidone that gets into the breastmilk is very small and side effects in the baby should not be expected. Domperidone is sometimes given to babies with reflux and the amount they get through the milk is a very small percentage of what they would get if they were treated with domperidone directly.
As a general recommendation, continue taking domperidone until your baby is well established on solid foods. Some people continue domperidone for many months and some beyond a year. Worldwide experience with domperidone over at least 40 years suggests that long-term side effects are uncommon.
The one therapeutic exception to taking the domperidone until the baby is well established on solids is when we use it for the baby who not latching on and the mother already has a very good milk supply. Once the baby is well latched on and drinking well at the breast, the mother can try stopping the domperidone after the baby has consistently latched on well and drinking well for at least a week. Even in this situation, weaning off the domperidone should not be abrupt, but slowly reducing the dose over a week or two.
When you are ready to stop taking domperidone, you should wean off it gradually. This is to prevent a possibly significant drop in your milk supply and side-effects (like anxiety and loss of appetite, sleepless ness) that may occur if domperidone is stopped suddenly, especially if you have been on domperidone for several months.
To wean from domperidone, decrease your daily dose by one tablet per day per week (so, for example, if you are taking 30 mg three times per day, or nine tablets per day, you would first decrease to eight tablets per day). After seven days, if you see no decrease in your milk supply, decrease the daily dose by one tablet again. Continue in this way until you have completely stopped the medication.
In 2004, the Federal Drug Administration (FDA) in the United States put out a warning against using domperidone because of possible heart-related side effects. However, these side effects occurred only when the drug was given intravenously to otherwise very sick patients, taking many other drugs.
In 2012, Health Canada endorsed a warning put forth by the company who manufacturers domperidone. This warning was about oral doses higher than 30 mg per day and the risk of heart-related side effects. However, the research cited to support this warning involved patients with an average age of over 70 years old, many of whom had pre-existing health conditions.
These warnings do not apply to the population to whom we prescribe domperidone (typically younger, healthy women) and we have continued to prescribe it to breastfeeding parents as we have for more than 30 years. We have treated thousands of people with domperidone and we are not aware of any one of them experiencing heart-related side effects due to domperidone. Also, as of 2015, Health Canada had never received any reports of serious heart-related adverse effects in anyone of childbearing age taking domperidone.
It is also known to produce significant increases in prolactin levels and has proven useful as a galactagogue 1 Serum prolactin levels have been found to increase from 8.1 ng/mL to 124.1 ng/mLin non-lactating women after one 20 mg dose 2. Concentrations of domperidone reported in milk vary according to dose but following a dose of 10 mg three times daily; the average concentration in milk was 2.6 ug/L 3 . In a study by da Silva, 16 mothers with premature infants and low milk production (mean=112.8 mL/d in domperidone group; 48.2 mL/d in placebo group) were randomly chosen to receive placebo (n=9) or domperidone (10 mg TID) (n=7) for 7 days 4. Milk volume increased from 112.8 to 162.2 mL/d in the domperidone group sand 48.2 to 56.1 mL/d in the placebo group. Prolactin levels increased from 12.9 to 119.3 ug/L in the domperidone group, and 15.6 to 18.1 ug/L in the placebo group. On day 5, the mean domperidone concentration was 6.6 ng/mL in plasma and 1.2 ng/mL in breastmilk of the treated group (n=6). No adverse effects were reported in infants or mothers.
Domperidone acts as a gastrointestinal emptying (delayed) adjunct and peristaltic stimulant. The gastroprokinetic properties of domperidone are related to its peripheral dopamine receptor blocking properties. Domperidone facilitates gastric emptying and decreases small bowel transit time by increasing esophageal and gastric peristalsis and by lowering esophageal sphincter pressure. Antiemetic: The antiemetic properties of domperidone are related to its dopamine receptor blocking activity at both the chemoreceptor trigger zone and at the gastric level. It has strong affinities for the D2 and D3 dopamine receptors, which are found in the chemoreceptor trigger zone, located just outside the blood brain barrier, which - among others - regulates nausea and vomiting
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