Question

I am a breastfeeding mother and i want to know if it is safe to use Domperidone? Is Domperidone safe for nursing mother and child? Does Domperidone extracts into breast milk? Does Domperidone has any long term or short term side effects on infants? Can Domperidone influence milk supply or can Domperidone decrease milk supply in lactating mothers?

Domperidone lactation summary

Domperidone is safe in breastfeeding
  • DrLact safety Score for Domperidone is 1 out of 8 which is considered Safe as per our analyses.
  • A safety Score of 1 indicates that usage of Domperidone is mostly safe during lactation for breastfed baby.
  • Our study of different scientific research also indicates that Domperidone does not cause any serious side effects in breastfeeding mothers.
  • Most of scientific studies and research papers declaring usage of Domperidone safe in breastfeeding are based on normal dosage and may not hold true for higher dosage.
  • Score calculated using the DrLact safety Version 1.2 model, this score ranges from 0 to 8 and measures overall safety of drug in lactation. Scores are primarily calculated using publicly available case studies, research papers, other scientific journals and publically available data.

Answer by Dr. Ru: About Domperidone usage in lactation

Drug which has been approved to be used for vomiting relief and as prokinetic medication in many countries. Usually prescribed to infants with gastroesophageal reflux disease by pediatricians, At usual adult dose (10 mg every 8 hours 2 weeks) may increase breast milk production by stimulating Prolactin release but it does not appear in significant concentration in the milk. It does not go across the blood brain barrier (lack of neurological effect). Because of these considerations Domperidone is a more appropriate drug as galactagogue. The best way to increase milk production would be a frequent and breastfeeding on demand together with an appropriate nursing technique. Domperidone should not be used without medical supervision. It has been related to increase risk of heart rhythm disorders (e.g. severe ventricular arrhythmia) in patients older than 60 years at a dose higher than 30 mg a-day who had other cardiac conditions (e.g. prolonged-QT) and when addtional medication that prolongs the QT interval was administered. The American Academy of Pediatrics rates it compatible with breastfeeding.

Answer by DrLact: About Domperidone usage in lactation

Domperidone is not approved for marketing in the United States by the U.S. Food and Drug Administration (FDA), but is available in other countries. Domperidone may also be available from some compounding pharmacies in the US. The quality of such products cannot be assured, and the FDA has warned against their use.[1] Data available from 4 small studies on the excretion of domperidone into breastmilk are somewhat inconsistent, but infants would probably receive less than 0.1% of the maternal weight-adjusted dosage. No adverse effects have been found in a limited number of published cases of breastfed infants whose mothers were taking domperidone. Domperidone is sometimes used as a galactogogue to increase milk supply.[2] Galactogogues should never replace evaluation and counseling on modifiable factors that affect milk production.[3] Most mothers who are provided instruction in good breastfeeding technique and breastfeed frequently are unlikely to obtain much additional benefit from domperidone. Whether domperidone has any benefit as a galactogogue in women who continue to have insufficient milk production after nursing technique and frequency have been optimized has not been adequately studied. A meta-analysis of 3 studies that compared domperidone to placebo or no treatment concluded that domperidone increased milk production.[4] However, another meta-analysis of the 2 studies of domperidone in the aforementioned meta-analysis that met strict inclusion criteria for treatment of demonstrated lactation insufficiency in mothers of preterm infants at more than 2 weeks postpartum found that although domperidone increased milk supply acutely, it might not improve long-term outcomes of breastfeeding in this population.[5] Results of a more recent study in mothers of preterm infants appears to support this conclusion.[6] Other reviewers concluded that improvement of breastfeeding practices seems more effective and safer than off-label use of domperidone.[7][8] Two meta-analyses of domperidone use as a galactogogue in mothers of preterm infants reviewed 5 double-blinded, placebo-controlled studies each with 3 common studies in each metanalysis. The meta-analyses found averages of 88 mL and 94 mL of increased daily milk production.[9][10] Domperidone has no officially established dosage for increasing milk supply. Most published studies have used domperidone in a dosage of 10 mg 3 times daily for 4 to 10 days. Two small studies found no statistically significant additional increase in milk output with a dosage of 20 mg 3 times daily compared to a dosage of 10 mg 3 times and that women who failed to respond to the low dosage did not respond to the higher dosage.[11][12] Dosages greater than 30 mg daily may increase the risk of arrhythmias and sudden cardiac death in patients receiving domperidone,[13] although some feel that the risk is less in nursing mothers because of their relatively younger age.[14] In one case, domperidone use uncovered congenital long QT syndrome in a woman who developed loss of consciousness, behavioral arrest, and jerking while taking domperidone.[15] Mothers with a history of cardiac arrhythmias should not receive domperidone and all mothers should be advised to stop taking domperidone and seek immediate medical attention if they experience signs or symptoms of an abnormal heart rate or rhythm while taking domperidone, including dizziness, palpitations, syncope or seizures.[13] Maternal side effects of domperidone reported in galactogogue studies and cases reported to the FDA include dry mouth, headache, dizziness, nausea, abdominal cramping, diarrhea, palpitations malaise, and shortness of breath. Some of these were more frequent with dosages greater than with 30 mg daily.[11][12][16][17][18] A survey of women taking domperidone for lactation enhancement found gastrointestinal symptoms, breast engorgement, weight gain, headache, dizziness, irritability, fatigue were the most common side effects reported.[19] Drug withdrawal symptoms consisting of insomnia, anxiety, and tachycardia were reported in a woman taking 80 mg of domperidone daily for 8 months as a galactogogue who abruptly tapered the dose over 3 days.[20] Another mother took domperidone 10 mg three times daily for 10 months as a galactagogue and stopped abruptly. After discontinuation, she experienced severe insomnia, severe anxiety, severe cognitive problems and depression.[21] A third postpartum woman began domperidone 90 mg daily, increasing to 160 mg daily to increase her milk supply. Because her milk supply did not improve, she stopped nursing at 14 weeks and began to taper the domperidone dosage by 10 mg every 3 to 4 days. Seven days after discontinuing domperidone, she began experiencing insomnia, rigors, severe psychomotor agitation, and panic attacks. She restarted the drug at 90 mg daily and tapered the dose by 10 mg/day each week. At a dose of 20 mg daily, the same symptoms recurred. She required sertraline, cl

Domperidone Side Effects in Breastfeeding

One paper reported 2 studies. In one, 8 women received domperidone 10 mg 3 times daily from day 2 to 5 postpartum. In the other, 9 women received domperidone 10 mg 3 times daily for 10 days from week 2 postpartum. No side effects were reported in any of the breastfed (extent not stated) infants.[24][25] Eleven women took domperidone 10 mg 3 times daily for 7 days to increase the supply of pumped milk for their preterm neonates. No side effects were reported in their infants.[26] In a study of 90 mothers who received domperidone 10 mg three times daily for 2 or 4 weeks while providing milk for their preterm infants, there was no apparent difference in the frequency or types of adverse events that occurred in their infants, whether taking the active drug or placebo.[6] A retrospective chart review of a breastfeeding clinic in Toronto identified 1005 infants whose mothers took domperidone as a galactogogue while nursing. No serious side effects were reported among breastfed infants. Nonserious side-effects were rare and appeared to be unrelated to domperidone (diaper rash, blood in urine, constipation and one case of arrhythmia with unknown cause and time of onset).[27]

Domperidone Possible Effects in Breastfeeding

Domperidone increases serum prolactin in lactating and nonlactating women.[11][28][29][30] This effect is thought to be caused by the drug's antidopaminergic effect. In nonpregnant women, domperidone is less effective than the same dose of oral metoclopramide in raising serum prolactin; however, in multiparous women their effects are similar.[28][30] Domperidone has caused galactorrhea in nonpregnant women[31][32][32][33][34][35] and in one male infant.[36] One study, which was published twice in 2 different journals,[24][25] reported two separate small studies. In the first study, 15 women with a history of defective lactogenesis were given either oral domperidone 10 mg (n = 8) or placebo (n = 7) 3 times daily from day 2 to 5 postpartum. The patients were apparently not randomized and blinding was not mentioned in the paper. No instruction or support in breastfeeding technique was provided. The groups had similar serum prolactin levels at the start of the study. Baseline serum prolactin levels were higher in the treated women from day 3 to 5 postpartum. Suckling-induced serum prolactin increases were higher in the treated women than in the placebo group from day 2 postpartum onward. Milk yield was calculated by weighing the infants before and after each nursing for 24 hours. Increase in milk yield were greater in the treated mothers from day 2 onward; however, the lower average milk yield in the placebo group was due to 3 women with very low milk output. Average infant weight gain was correspondingly greater in the treated group. At 1 month postpartum, all treated mothers were nursing well, but 5 of 7 untreated mothers had inadequate (not defined) lactation. No correlation was found between baseline serum prolactin or the increase in prolactin and milk production. In the same paper(s), 17 primiparous women who had insufficient lactation (30% below normal) at 2 weeks postpartum were studied using the same methodology as above. Mothers were given either oral domperidone 10 mg (n = 9) or placebo (n = 8) 3 times daily for 10 days. The groups did not have significantly different serum prolactin levels at the start of the study. Serum prolactin levels were higher in the treated than untreated women from day 2 onward and milk production was higher in the treated group from day 4 onward. At the end of the study no untreated woman had an increase in milk supply from day 1. One month after the beginning of the study, all treated women had adequate milk production. No correlation was found between serum prolactin and milk production.[24] One well-designed, but small trial was reported with domperidone. Twenty women who were pumping milk with a good quality electric pump for their preterm infants were given either oral domperidone 10 mg (n = 11) or placebo (n = 9) 3 times daily for 7 days in a randomized, double-blind, trial. The mothers averaged 32 to 33 days postpartum. All had failed to produce sufficient milk for their infant after extensive counseling by lactation consultants. By day 5 of therapy, the serum prolactin levels of the treated mothers had increased by 119 mcg/L in the treated group compared to 18 mcg/L in the placebo group. Serum prolactin decreased to baseline levels in both groups 3 days after discontinuation of the study medications. Although the (partially imputed) baseline milk production was greater in the domperidone group (113 mL daily) than in the placebo group (48 mL daily), the average daily increases in milk production on days 2 to 7 were 45% (to 184 mL) and 17% (to 66 mL) in the domperidone and placebo groups, respectively. However, 4 women in the domperidone group failed to complete the study and only the study completers were matched and found to be similar at baseline. No follow-up beyond the 7-day study period was done to evaluate the persistence of an effect of domperidone on lactation success.[26] While this study appears to offer evidence of a beneficial effect on the milk supply in the mothers of preterm infants who are pumping their milk, several factors make this conclusion questionable: a 36% drop-out rate in the active drug group, the lack of an intent-to-treat analysis, and the vast difference in baseline milk supply between the domperidone and placebo groups. Twenty-five women who had been given domperidone 20 mg 4 times daily to increase milk supply had their dosages decreased over 2 to 4 weeks and discontinued. The duration of domperidone use was not stated in the abstract. All women had stable milk output and were nursing infants under 3 months of age who were growing normally. Of the 25 women, 23 did not increase their use of formula and all infants grew normally, indicating that domperidone can be withdrawn without a detrimental effect on infant nutrition.[37] Six women who were unable to produce sufficient milk for their preterm infants after counseling by lactation consultants were given domperidone in dosages of 10 mg 3 times daily or 20 mg 3 times daily in a cr

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