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Zuranolone (Zurzuvae™)  and Breastfeeding

Back in August 2023 I posted about a new drug Zuranolone licensed by the FDA in USA to treat perinatal depression. The course lasts just 2 weeks but the manufacturer was recommending that mothers shouldn’t breastfeed on it or for a week after.

However, this afternoon (September 2023)I was listening to a webinar by Dr Tom Hale and Dr Kaytlin Krutsch where they presented data on 15 women who took it but pumped throughout.

“The manufacturer reports minimal transfer into breast milk. The concentration of drug-in-milk quantified in the milk was not disclosed; however, the mean RID was reported as 0.357% at day 5 (dose unknown; 30 to 50 mg per day). The oral bioavailability of zuranolone is unknown, but the reported RID% would likely result in negligible infant exposure.

Zuranolone has a dose-dependent abuse potential; patients report feeling euphoric mood, feeling drunk, and somnolence with zuranolone use. Adverse effects upon discontinuing the drug in the mother may include mild-to-moderate insomnia, palpitations, decreased appetite, paranoia, hyperhidrosis, nausea, and more. For the mother, there is a risk of excessive sedation with the potential inability of the mother to assess the degree of their impairment. This was not noticed in the lactation study. Instead, patients reported mild dizziness and potential memory loss during the treatment.[Poster: An open-label study to evaluate concentrations of zuranolone in the breastmilk of healthy lactating women. Available upon request to the manufacturer. Sage Therapeutics/BioGen Inc. 2021.]

Progesterone is thought to inhibit lactation. Researchers reported the average milk volume trended 8.3% down from a mean of 526 mL on day 1 to 485 mL on day 3 to 5 (when steady-state was reached). Moms were required to exclusively pump for the trial, which may partially explain the drop in volume.”

It is recommended that the baby so exposed through milk is monitored for sedation.

see also LactMed https://www.ncbi.nlm.nih.gov/books/NBK594292/

“Because of the low amounts of zuranolone in milk, it would not be expected to cause any adverse effects in breastfed infants. If zuranolone is required by the mother, it is not a reason to discontinue breastfeeding. Until more data are available, zuranolone should be used with careful infant monitoring for excessive sedation during breastfeeding, especially with higher dosages and in newborn and preterm infants.”

“The manufacturer reports a study in 14 healthy lactating women treated with oral administration of 30 mg of zuranolone daily for 5 days. The daily infant dose was approximately 0.0013 mg/kg, resulting in a mean weight-adjusted relative infant dose of 0.357% compared to the maternal dose. Concentrations of zuranolone in breastmilk were below the level of quantification limit by 4 to 6 days after the last dose.”

To my knowledge this drug is not yet approved in the UK.

  • Mahase  E US approves daily pill for postpartum depression https://www.bmj.com/content/382/bmj.p1822
  • Perinatal depression: a neglected aspect of maternal health https://www.thelancet.com/pdfs/journals/lancet/PIIS0140-6736(23)01786-5.pdf
  • Deligiannidis KM, Meltzer-Brody S, Gunduz-Bruce H, et al. Effect of Zuranolone vs Placebo in Postpartum Depression: A Randomized Clinical Trial. JAMA Psychiatry. 2021;78(9):951–959.
  • Deligiannidis KM, Meltzer-Brody S, Gunduz-Bruce H, Doherty J, Jonas J, Li S, Sankoh AJ, Silber C, Campbell AD, Werneburg B, Kanes SJ, Lasser R. Effect of Zuranolone vs Placebo in Postpartum Depression: A Randomized Clinical Trial. JAMA Psychiatry. 2021 Sep 1;78(9):951-959. doi: 10.1001/jamapsychiatry.2021.1559. Erratum in: JAMA Psychiatry. 2022 Jul 1;79(7):740. Erratum in: JAMA Psychiatry. 2023 Feb 1;80(2):191. PMID: 34190962; PMCID: PMC8246337.
  • An open-label study to evaluate concentrations of zuranolone in the breastmilk of healthy lactating women. Available upon request to the manufacturer. Sage Therapeutics/BioGen Inc. 2021

Phenylephrine and Breastfeeding

I have written extensively about the use of decongestants in the past ( https://breastfeeding-and-medication.co.uk/fact-sheet/coughs-colds-flu-and-covid-when-breastfeeding and https://www.breastfeedingnetwork.org.uk/factsheet/decongestants/)

Pseudoephedrine has been shown to reduce milk supply in some women. The effect of phenylephrine on supply has not been demonstrated but use of oral decongestants is generally not advised for breastfeeding women.

 I have always recommended the use of nasal sprays as decongestants together with the use of steam inhalation as being more effective than oral medication and with no potential  impact on supply.

In September 2023 the FDA reported that oral phenylephrine is not effective at relieving nasal stuffiness. It is important to note that neither FDA nor the Non-prescription Drug Advisory Committee raised concerns about safety issues with use of oral phenylephrine at the recommended dose. (https://www.fda.gov/drugs/drug-safety-and-availability/fda-clarifies-results-recent-advisory-committee-meeting-oral-phenylephrine).

According to one USA website the evidence for efficacy was first questioned in 2007. The manufacturers have cited a survey that many people find its use beneficial as shown by sales volume of cough and cold products.

The vote that formally declared phenylephrine ineffective was in line with a review of pharmacology and clinical data presented by the FDA, which found the oral bioavailability of the drug is less than 1%, compared with 38%, a number often cited in the literature and based on outdated technology. (Medscape https://www.medscape.com/viewarticle/996369).

There appears to be no current UK recommendations although I am sure there is current discussion. Most oral cough and cold remedies currently contain phenylephrine as pseudoephedrine  sales have been restricted.   Between 2007 and 2008, the government introduced restrictions on their use because of concern that medicines containing these active substances could be used in the illicit manufacture of the Class A controlled drug methylamphetamine https://www.gov.uk/drug-safety-update/pseudoephedrine-and-ephedrine-update-on-managing-risk-of-misuse#:~:text=Sales%20restrictions,-Since%20April%202008&text=It%20is%20illegal%20to%20sell,mg%20ephedrine%20without%20a%20prescription

This information has been compiled from a variety of sources and does not imply recommendation other than that nasal decongestants and steam inhalation are effective in reducing symptoms of nasal congestion during breastfeeding without potential impact on supply. Most of us have our own preferred remedies which we find effective and that remains a personal choice

Rimegepant (Vydura™)  and Breastfeeding

Rimegepant (Vydura ™) is indicated for adults who have at least 4 migraine attacks per month but less than 15. It is taken as a wafer which dissolves under the tongue. It works by stopping the release of a protein around the brain that is responsible for the severe pain associated with migraine attacks.

It is recommended as an option for preventing episodic migraine in adults where at least 3 previous preventive treatments have failed (NICE May 2023)

In a study by Baker et al (2022) 12 breastfeeding mothers aged 18-40 years provided plasma and breastmilk samples over a 36 hour period.

It is highly protein bound 96%, with an oral bioavailability 64%, and milk plasma ratio 0.2. On a weight-adjusted basis, infants received an estimated dose that was approximately 0.51% of the maternal dose (Hale).

References

  • Baker TE, Croop R, Kamen L, Price P, Stock DA, Ivans A, Bhardwaj R, Anderson MS, Madonia J, Stringfellow J, Bertz R, Coric V, Hale TW. Human Milk and Plasma Pharmacokinetics of Single-Dose Rimegepant 75 mg in Healthy Lactating Women. Breastfeed Med. 2022 Mar;17(3):277-282

Fremanezumab (Ajovy™)  and Breastfeeding

Fremanezumab is a humanised monoclonal antibody that binds to the calcitonin gene-related peptide (CGRP) ligand, inhibiting the function of CGRP at its receptor, and thereby preventing migraine attacks (BNF). It is given as a sub cutaneous injection of 225 mg once a month, alternatively 675 mg every 3 months.

Fremanezumab is recommended for patients who have 4 or more migraine days a month and for whom at least 3 preventive drug treatments have failed and the drug is supplied by the company under a commercial agreement agreed with NICE. It is unclear if fremanezumab works better than botulinum toxin type A (NICE)

It has a molecular weight of 148,000 and assumed low oral bioavailability. However, there are no studies in breastfeeding mothers and babies although any passing into milk  is presumed to be destroyed in the infant gut (LactMed)

References

GP Presentation

Sharing a presentation which was given to GPs in the south west. Hopefully it is useful for professionals wanting to know more about prescribing for breastfeeding mothers

Timing of breastfeeds if taking medication

I keep getting emails/ Facebook messages that mothers have been advised to pump and dump their breastmilk for a period of time after taking medication in order to minimise / prevent exposure of the baby to the drug. This has often been undertaken when the drug is compatible with breastfeeding and resulted in the unnecessary exposure of the baby to formula milk.

For most drugs taken for more than 3 days the amount in milk is constant across 24 hours. So timing feeds with respect to breastfeeding or dumping of the breastmilk is pointless. The half life of a drug is very important but just one of the factors in determining the compatibility with normal breastfeeding. If you want to know more please consider buying “Breastfeeding and Medication”

pdf of information Timing of medication and breastfeeds

Timing of drugs with respect to medication does not help to minimise levels to which babies are exposed in chronic conditions. Although the time to maximum level is often quoted, drugs reach a steady state 3-5 days after therapy begins and the levels then remain constant across the 24-hour period. Just as it takes approximately 5 half- lives for a drug to leave the body totally, it takes 5 half-lives to reach steady state. Before this time the levels increase gradually with every dose until they reach this point. Trying to time feeds disrupts normal breastfeeding and may result in engorgement with no benefit in milk levels to which the baby will be exposed. See Fig  1 below

Fig 1 accumulation of drug until it reaches steady state after 5 half lives (here taken to be 24 hours)

The half-life of a drug defines how long it takes to reach steady state and also how long it takes for it to be totally cleared from the mother’s body and milk. Five half-lives are taken as the closest measure in both cases.

Fig 2 Percentage of drug left where half-life is 24 hours

If the half-life of the drug is more than 24 hours the level may begin to accumulate in the baby’s body and be more likely to produce adverse effects e.g. diazepam half-life 43 hours.   Drugs with short half lives are preferred during breastfeeding. In  general long acting / slow release formulations are better avoided if possible.

Fig 2 Percentage of drug left where half-life is 24 hours

Norethisterone and breastfeeding

Many mothers take norethisterone to delay periods before holidays or even their wedding. Others use it to stop heavy bleeding and wish to continue to breastfeed.

Norethisterone and breastfeeding factsheet

Norethisterone 5mg tablets (Primolut N®, Utovlan®) is often prescribed to delay periods. This might be requested by the breastfeeding mother for example before a holiday or a wedding. There is little information from the research databases to support the use at this dose in breastfeeding. The only references are significantly lower doses (350mcg daily) used in progesterone only contraceptives.

It is suggested in the literature that this dose of norethisterone may reduce the quantity of breastmilk. In my experience a few mothers have noticed a temporary dip in supply but with holidays and weddings a change of routine could account for such a change. There seems to be no risk to the breastfeeding baby of a short course of medication at this dose.

Studies suggest that lower doses do not affect the composition of milk (reported in LACTMed. However Hale (Medications and Mother’s Milk states that although it is believed to be secreted into breast milk in small amounts, it may reduce lactose content and reduce overall milk volume and nitrogen/protein content, resulting in lower infant weight gain, although these effects are unlikely if doses are kept low. Norethisterone is a component of progestin oral contraceptives (Eg. Micronor™ and Brevinor ™ )

BNF : Postponement of menstruation 5mg norethisterone  3 times daily starting 3 days before expected onset (menstruation occurs 2–3 days after stopping)

N.B This information is based on anecdote and not research based studies

References

  • https://www.e-lactancia.org/breastfeeding/norethisterone/product/
  • https://www.ncbi.nlm.nih.gov/books/NBK501291/
  • Jones W Why Mother’s Medication Matters
  • Jones W Breastfeeding and Medication

Anti platelet drugs and breastfeeding

Although it is rare for a young woman to experience a heart attack, transient ischaemic attack or stroke, it does happen. They are usually prescribed anti-platelet drugs and until recently we found difficulty in providing information. However, this is the most up to date information which I have sourced and hope it helps anyone in this most difficult position.

pdf of factsheet Anti platelet drugs and breastfeeding factsheet

Anti-platelet drugs decrease platelet aggregation (stickiness) and may stop thrombus (clot)
formation. Clopidogrel is also used, sometimes alone or in combination with low-dose aspirin. There are unfortunately some mothers who, whilst breastfeeding, have a heart attack, transient ischaemic attack, stroke or other event that requires anti-platelet agents if only temporarily. Anti-platelets may also be given during investigation if such a condition is strongly suspected.
Aspirin dispersible 75 mg
Aspirin 75 mg acts by decreasing platelet stickiness irreversibly inhibiting aggregation. It is not used during treatment of thrombosis but may be used to after a myocardial infarction (MI), transient ischaemic attack and stroke or to decrease cardiovascular risk. It is also used to prevent recurrent miscarriage, with a past history of pre-eclampsia and other reasons in pregnancy (https://breastfeeding-and-medication.co.uk/fact-sheet/low-dose-aspirin-and-breastfeeding). Aspirin is not recommended during breastfeeding at analgesic doses of 600 mg four times a day, due to its association with Reye’s syndrome. However, use of low dose aspirin is considered acceptable. In the absence of the theoretical risk of association with Reye’s syndrome, aspirin would be a drug compatible with lactation due to its pharmacokinetic properties.

Milk Plasma ratio is 0.03-0.08, oral bio availability 50-75%, plasma protein binding 88-93%, relative infant dose 2.5% – 10.8%. There is no documented risk of association with Reye syndrome. Virtually all aspirin is metabolised 2-3 hours after dose.
Clopidogrel (Brand name: Plavix®)
Little is known about the levels of clopidogrel secreted into breastmilk but it’s likely to be a small amount (https://www.nhs.uk/medicines/clopidogrel/). Clopidogrel irreversibly modifies the platelet adenosine diphosphate (ADP) receptor. There are no human studies, but rat studies have shown passage into milk. This significance in human treatment is unknown. It’s unlikely that clopidogrel will cause any side effects in the baby. It is used with good tolerance in paediatrics, even in new-borns and infants (https://www.e-lactancia.org/breastfeeding/clopidogrel/product/)
The pharmacokinetics of clopidogrel show a low oral bio availability 50%, plasma protein binding 98%. Babies exposed to clopidogrel through their mother’s breastmilk should be monitored for rare bruising on the skin, blood in urine, vomit or stool.
Gastric irritation of aspirin and clopidogrel
Both aspirin and clopidogrel (Plavix ™) are gastro irritant so may need to be used with a proton pump inhibitor (PPI) for protection of the stomach. There has in the past been some concern over a potential interaction between clopidogrel and omeprazole and esomeprazole, with the anti-platelet effect of clopidogrel being diminished (https://www.gov.uk/drug-safety-update/clopidogrel-andproton-pump-inhibitors-interaction-updatedadvice#:~:text=Concomitant%20use%20of%20clopidogrel%20and,therapies%20would%20be%20mo
re%20suitable.) .

The Specialist Pharmacy Service suggest that this is a clinical decision but that
pantoprazole, lansoprazole and rabeprazole are suitable alternatives
(https://www.sps.nhs.uk/articles/do-proton-pump-inhibitors-reduce-the-clinical-efficacy-ofclopidogrel-2/). PPI medication is largely destroyed in the maternal gut and can be used during lactation.
Other anti-platelet drugs

  • Prasugrel (Effient) No studies on the transfer of prasugrel into breastmilk are available
  • Ticagrelor (Brilinta) No studies on the transfer of prasugrel into breastmilk are available
  • Dipyridamole No studies on the transfer of prasugrel into breastmilk are available

References

  • CKS Anti platelet treatment https://cks.nice.org.uk/topics/antiplatelettreatment/management/secondary-prevention-of-cvd/
  • Elactancia https://www.e-lactancia.org/
  • Finkelstein Y, Nurmohamed L, Avner M, Benson LN, Koren G. Clopidogrel use in children. J
    Pediatr. 2005 https://pubmed.ncbi.nlm.nih.gov/16291359/
  • Hale Medications and Mothers Milk Online Access
  • Kwok CS, Loke YK, Effects of proton pump inhibitors on platelet function in patients receiving
    clopidogrel: a systematic review, Drug Saf, 2012;35(2):127–39.
  • Kwok CS, Loke YK, Inconsistencies surrounding the risk of adverse outcomes with
    concomitant use of clopidogrel and proton pump inhibitors, Expert Opin Drug Saf,
    2012;11(2):275–84.
  • LactMed https://www.ncbi.nlm.nih.gov/books/NBK501922/
  • LactMed Lansoprazole https://www.ncbi.nlm.nih.gov/books/NBK501283/
  • LactMed Pantoprazole https://www.ncbi.nlm.nih.gov/books/NBK501280/
  • LactMed Rabeprazole https://www.ncbi.nlm.nih.gov/books/NBK501282/
  • Li JS, Yow E, Berezny KY, Bokesch PM, Takahashi M, Graham TP Jr, Sanders SP, Sidi D, Bonnet
    D, Ewert P, Jennings LK, Michelson AD; PICOLO Investigators. Dosing of clopidogrel for
    platelet inhibition in infants and young children: primary results of the Platelet Inhibition in
  • Children On clopidogrel (PICOLO) trial. Circulation. 2008
  • https://pubmed.ncbi.nlm.nih.gov/18195173/
  • NHS Clopidogrel. https://www.nhs.uk/medicines/clopidogrel/
  • Patient Info Antiplatelet Drugs https://patient.info/doctor/antiplatelet-drugs

Domperidone as a galactogogue

Many women report lowered milk supply ( perceived or actual) and it is a cause of many contacts to breastfeeding experts and sadly a reason many mothers turn to formula when they hadnt intended. Domperidone has for a long time been recommended to help increase supply by utilsising its ability to increase prolactin. It shouldnt be used, in my opinion unless the mother has been supported to achieve regular and effective breastfeeding. It may be needed where a premature baby has been delivered and the mother has been pumping long term – many times the supply starts to dip after 2 weeks.

pdf of this information:

https://breastfeeding-and-medication.co.uk/wp-content/uploads/2022/11/domperidone-as-a-galactogogue.pdf

See also UKDILAS information on domperidone and low milk supply https://www.sps.nhs.uk/articles/using-domperidone-for-low-milk-supply

I wrote a factsheet for BfN looking at all the studies on study outcomes some years ago (https://www.breastfeedingnetwork.org.uk/domperidone/ ) . This information is an update on my thoughts and in light of experience and new reports.

Some years ago I wrote a factsheet for the Breastfeeding Network on the use of domperidone as a galactagogue when the recommendations for the use of domperidone changed
https://www.breastfeedingnetwork.org.uk/domperidone/. The MHRA and EHRA recommended that domperidone be prescribed only in limited situations and at a maximum dose of 10mg three times a day for 7 days and not for breastfeeding mothers https://www.gov.uk/drug-safetyupdate/domperidone-risks-of-cardiac-side-effects.
Domperidone has long been used as a galactagogue to increase milk supply. Most of the evidence from studies lies with use to increase lactation after premature delivery but can be used later where breastfeeding got off to a difficult start such as separation of mother and baby. The research studies on domperidone and use to increase milk supply can be found in the BFN link. In my experience it had been used when adequate breastfeeding support had not been given and when feeding was not effective or frequent enough to stimulate supply. This should always be the first intervention and should be happening at every professional contact with a breastfeeding mother.
When should domperidone not be used ?
Domperidone interacts with other medication and should not be used:

  • before assessment by someone skilled in breastfeeding support alongside expressing both
    breasts, at least 8-10 times in 24 hours including overnight
  • where either mother or baby has any evidence of cardiac abnormalities and specifically
    arrhythmia
  • where either is receiving other medications known to prolong QT interval or potent CYP3A4
    inhibitors e.g., quinolone antibiotics, ketoconazole, fluconazole, macrolide antibiotics, SSRI
    antidepressants (risk low with most commonly used ( Funk 2013) tricyclic antidepressants,
    salbutamol (https://ggcmedicines.org.uk/media/uploads/ps_extra/pse_21.pdf)
  • where severe hepatic impairment has been identified in mother or baby
  • where either mother or baby has high or low levels of potassium, or low levels of magnesium (https://ggcmedicines.org.uk/media/uploads/ps_extra/pse_21.pdf)

Are there adverse effects of domperidone on babies exposed through their mother’s milk? Hale data(2022) : milk plasma ratio 0.25% (<1 regarded as compatible with breastfeeding), plasma protein binding 93% leaving only 7% which can pass into milk, oral bioavailability 13-17% because of extensive first pass metabolism, relative infant dose 0.01%-0.35% (< 10% regarded as compatible with breastfeeding. Analysis of studies not complete but indicative of low risk to babies of domperidone passing to baby and would be grounds for use in breastfeeding to be reconsidered by EHRA and MHRA.

Higher doses of domperidone to increase milk supply?
Some breastfeeding experts have used significantly higher doses of domperidone to stimulate
lactation and continued use long term without reported adverse effects (Newman J, Polokova A What Doctors Don’t Know About Breastfeeding 2022)
Tapering off dose
There are no studies that provide an evidence base on how long to continue domperidone in the case of inadequate lactation (Academy of Breastfeeding Medicine (ABM) 2018 Anecdotally, some women feel that their supply cannot be maintained without the drug, while some can reduce the dose but not stop altogether. It is possible that domperidone is acting as a placebo to boost their confidence – we do not know and should admit the limitations of the research.
After a slow withdrawal from domperidone, one study found no significant increase in formula
supplementation suggesting that once sufficient milk production is established, it is maintained even without the use of domperidone (Livingston 2007).
Knoppert (2012) showed that in 3 out of 4 women who had taken domperidone for 4 weeks at full dose, 2 weeks at reducing dose, milk supply was maintained. Although gradual weaning from the drug has become standard, there is little published evidence apart from the reports and data is based on the experience of breastfeeding specialists.
Withdrawal
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 (Papastergiou 2013).

Another mother (Seeman2015) 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.

A third postpartum woman (Doyle 2018) 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 daily each week. At a dose of 20 mg daily, the same symptoms recurred. She required sertraline, clonazepam and reinstitution of domperidone at 40 mg daily, slowly tapering the dose over 8 weeks. Three months were required to fully resolve her symptoms.

In a fourth case (Manzouri 2017), a mother took domperidone 20 mg four times daily for 9 months to stimulate breastmilk production. She stopped breastfeeding and domperidone at that time. Two weeks later, she presented with insomnia, anxiety, nausea, headaches and palpitations. The drug was restarted at a dosage of 20 mg three times daily and began to taper the daily dosage by 10 mg every week, but after one week she complained of insomnia. Tapering was reduced to 5 mg every week, but whenever she stopped the ndrug, symptoms returned. She was able to discontinue domperidone after tapering the daily dosage by 2.5 mg weekly over 10 months A fifth case (Sharma 2022) of a mother with a history of bipolar disorder and major depression developed severe anxiety, a recurrence of depression and obsessive compulsive disorder 6 days after abruptly discontinuing domperidone 120 mg daily that she was aking as a galactogogue. Three days later, she restarted domperidone 120 mg daily and tapered her daily dose by 10 mg at weekly intervals. She took no other medications. Two weeks after discontinuing domperidone, she had signs of only mild mood disorder. Hale (2022) reports an increase in calls to InfantRisk reporting problems with withdrawal after high dose and long-term use.


This should in my opinion be discussed with the mother before prescription of the medication.
References

  • Academy of Breastfeeding Medicine ABM Clinical Protocol #9: Use of Galactogogues in
    Initiating or Augmenting Maternal Milk Production, Second Revision Bodribb W 2018.
    Breastfeed Med. 2018 Jun;13(5):307-314
  • Asztalos EV, Kiss A, daSilva OP, Campbell-Yeo M, Ito S, Knoppert D; EMPOWER Study
    Collaborative Group. Evaluating the Effect of a 14-Day Course of Domperidone on Breast
    Milk Production: A Per-Protocol Analysis from the EMPOWER Trial. Breastfeed Med. 2019
    Mar;14(2):102-107. doi: 10.1089/bfm.2018.0175. Epub 2018 Dec 13. PMID: 30543461.
  • Campbell-Yeo ML, Allen AC, Joseph KS et al. (2010) Effect of domperidone on the
    composition of preterm human breast milk. Pediatrics 125(1): e107-114.
  • da Silva OP, Knoppert DC, Angelini MM et al. (2001) Effect of domperidone on milk production in mothers of premature newborns: a randomized, double-blind, placebo-controlled
    trial. CMAJ 164(1): 17-21
  • da Silva OP, Knoppert DC. (2004) Domperidone for lactating women. CMAJ 171(7): 725
  • Doyle M, Grossman M. Case report: domperidone use as a galactagogue resulting in
    withdrawal symptoms upon discontinuation. Arch Womens Ment Health. 2018
    Aug;21(4):461-463. doi: 10.1007/s00737-017-0796-8. Epub 2017 Oct 31. PMID: 29090362.
  • Funk KA, Bostwick JR. A comparison of the risk of QT prolongation among SSRIs. Ann
    Pharmacother. 2013 Oct;47(10):1330-41)
  • Grzeskowiak LE, Smithers LG, Amir LH, Grivell RM. Domperidone for increasing breast milk
    volume in mothers expressing breast milk for their preterm infants: a systematic review and
    meta-analysis. BJOG. 2018 Oct;125(11):1371-1378. doi: 10.1111/1471-0528.15177. Epub
    2018 Mar 27. PMID: 29469929.
  • Grzeskowiak LE, Wlodek ME, Geddes DT. What Evidence Do We Have for Pharmaceutical
    Galactagogues in the Treatment of Lactation Insufficiency?-A Narrative Review. Nutrients.
    2019 Apr 28;11(5):974. doi: 10.3390/nu11050974. PMID: 31035376; PMCID: PMC6567188.
  • Hale TW and Krutsch K Medications and Mothers Milk 2022 Springer Publications
  • Ingram J, Taylor H, Churchill C, Pike A, Greenwood R, Metoclopramide or domperidone for
    increasing maternal breast milk output: a randomised controlled trial Arch Dis Child Fetal
    Neonatal Ed F2 of 5(2011). doi:10.1136/archdischild-2011-300601
  • Knoppert DC, Page A, Warren J, Carr M, Angelini M, Killick D, DaSilva OP, The Effect of Two
    Different Domperidone Doses on Maternal Milk Production published online 3 May 2012 J
    Hum Lact
  • Livingston V, Blaga Stancheva L, Stringer J. The effect of withdrawing domperidone on
    formula supplementation. Breastfeeding Med. 2007; 2:278, Abstract 3.

Arnica (homeopathic)

Homeopathic arnica has been recommended for many years to relieve bruising and promote healing after birth. There is little research but historical use suggests that ” homeopathic products and topical application are usually safe during breastfeeding” LactMed https://www.ncbi.nlm.nih.gov/books/NBK501828/

Homeopathic remedies (https://kellymom.com/bf/can-i-breastfeed/herbs/natural-treatments/)

“Although there is little – if any – professional literature in this field on the use of homeopathic medicine, my reading and research has led me to the conclusion that these remedies pose minimal – if any – risk to the nursing baby. Homeopathic remedies are reportedly very safe for nursing moms and babies because the remedies (by definition of homeopathy) contain only very dilute versions of the active substances.

Most experts believe that homeopathic remedies are unlikely to pose a problem for the nursing baby and mother.”

Adults and children:2 pillules every 2 hours for the first 6 doses, then 4 times daily for up to 5 days or until symptoms improve https://www.nelsonspharmacy.com/arnicare-arnica-30c-clikpak. Although Nelsons website states that you should “Consult your doctor or pharmacist before taking this product if you are pregnant or breast feeding”

Arnica cream should not be applied to broken skin.

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