Naproxen is frequently used as an anti inflammatory and to add pain relief for instance after surgery. However, there seems to be concern about prescribing it for the breastfeeding mother. I hope this information helps.
pdf of information Naproxen and Breastfeeding factsheet
If it was useful maybe you need to buy the book?
Naproxen is an anti-inflammatory drug used more frequently since concerns were raised about long term cardiovascular risk of diclofenac. It is generally seen as more effective than ibuprofen. Concerns have been raised that its longer half life produces more of a risk to a breastfeeding baby. It is only taken twice a day at 12 hourly intervals.
Naproxen is more than 99% bound to plasma proteins. Davies and Anderson (1997) reported that although naproxen is excreted into breastmilk, the amount of drug transferred comprises only a small fraction of the maternal exposure. Relative infant dose quoted as 3.3% (Hale 2023 online access) lower than 10% regarded as compatible with breastfeeding.
In Jamali and Stevens’ study (1983) only 0.26% of the mother’s dose was recovered from the infant and adverse effect reports are low.
The BNF considers that the amount of naproxen distributed into breastmilk is too small to be harmful to a breastfed infant; however, some manufacturers recommend that breastfeeding should be avoided during naproxen therapy, due to licensing considerations rather than potential risk.
References see Breastfeeding and Medication Text
Before I start talking about quitting smoking, I want to acknowledge that it isnt easy. Nicotine is very addictive, and everyone smokes for their own reasons. Everyone has a habit they would like to break: mine is enjoying too much chocolate. To stop doing anything which you enjoy takes guts and a lot of will power. Maybe your baby is your reason to quit but it also needs to be because YOU want to not just because you have been TOLD to. I hope this information helps you but always happy to help if you want to email me firstname.lastname@example.org
Smoking in Pregnancy
We know that smoking during pregnancy is associated with risk factors to the baby including low birth weight at delivery, increased risk of miscarriage or stillbirth because carbon monoxide in tobacco smoke reduces the amount of oxygen getting to the placenta and the baby . There are also future risks of respiratory problems including ear, nose and throat. However as at 2020/21 9.5% of women were smoking at the time of delivery which was the lowest on record.
In a 2010 study by the Office of National Statistics (ONS) 14% of women were smoking before pregnancy but gave up, 12% continued to smoke throughout pregnancy although 9% cut down. The study showed that 1% gave up but went back to smoking during the pregnancy.
A report published by the Royal College of Physicians in 2010 estimated that in the UK, smoking during pregnancy causes up to 5,000 miscarriages, 300 deaths around the time of birth and approximately 2,200 premature births each year.
Why do mothers smoke during pregnancy?
Why, might we ask, knowing that smoking during pregnancy is harmful to the baby do so few expectant mothers not quit? The answer is very simple: nicotine is extremely addictive and it is hard to break the habit of smoking. Just as overwight people know that they need to lose weight, try to diet but often return to their original weight or more.
Smoking is often linked to deprivation and women may smoke because they cannot afford to eat. If you live with someone else who smokes, you are six times more likely to smoke throughout pregnancy. Additionally, those who live with a smoker and manage to quit are more likely to relapse once the baby is born. If all your friends smoke, especially if you are younger, it is much harder to quit so peer pressure has much to answer to.
How can you stop smoking?
Over half (53%) of the women in a large 2010 study had been given information on how to stop smoking, and a third had received information on how to cut down smoking (32%) and how their partner could stop smoking (33%) but still had not quit. Maybe you have been given the information and now want to quit but have felt “nagged” into doing so when you aren’t ready?
Midwives, pharmacists, GPs as well as smoking cessation clinics can provide nicotine replacement products. These are free on the NHS whilst you are pregnant.
In April 2023 Health Minister Neil O’Brien announced that following the success of local schemes, pregnant women will be offered financial incentives to help them stop smoking. This will involve offering vouchers, alongside behavioural support, to all pregnant women who smoke by the end of 2024.
Nicotine replacement therapy
You can use nicotine replacement therapy (NRT) during pregnancy if it will help you stop smoking and you’re unable to stop without it. It’s not recommended that you take stop smoking tablets such as Champix or Zyban during pregnancy.
Smoking cessation interventions have been shown to reduce the number of new-borns with low birth weight and preterm births. In one study, compared to ongoing heavy smoking, quitting was associated with a 299g increase in birth weight. The less a premature baby weighs at birth the more interventions it is likely to need and the longer it will stay in NICU (neonatal intensive care unit).
NRT contains only nicotine and none of the hundreds of other damaging chemicals found in cigarette smoke. Tobacco smoke contains over 7,000 chemical compounds. NRT is a better option than continuing to smoke. It helps you by giving you the nicotine you would have had from a cigarette whilst you break the habit of reaching for a cigarette ( see below for how to break the habit of smoking).
NRT is available as:
- Patches (The 16-hour NRT patches are preferred to the 24-hour period ones)
- nasal spray
- mouth spray
- oral strips
- micro tabs
Sometimes a combination of a sustained release patch together with a rapid delivery method works well. As a pharmacist smoking cessation advisor, I often found that the people I was working with found it easier if they had something to hold in their mouths or their hands, so benefitted from an inhalator even if it didn’t contain a product.
Vaping and pregnancy
The vapour from an e-cigarette does contain some of the potentially harmful chemicals found in cigarette smoke, but at much lower levels. If using an e-cigarette helps you to stop smoking, it is much safer for you and your baby than continuing to smoke.
E-cigarettes may be more effective than nicotine patches for pregnant women trying to quit smoking, research found. One major study did not raise any new safety concerns with e-cigarettes (vaping) in pregnancy.
Smoking and breastfeeding
- Nicotine is found in breastmilk of mothers who smoke together with Cotinine, Cadmium, Mercury, Lead and other heavy metals, and a lower amount of proteins, Vitamin A, C and E and other antioxidants.
- The flavour of breastmilk collected 30-60 minutes after smoking was identified as tasting more like cigarettes than samples taken at any other time.
- The levels of cotinine (the chemical into which nicotine is changed in the body) in the urine of breastfed babies whose mothers smoked were ten times higher than those of formula fed babies of smoking mothers. It appears that this is due to passage through breastmilk and not through exposure to smoke in a room.
- Babies of mothers who smoke appear to be more likely to suffer from colic.
- Smoking appears to lower breastmilk production by reducing prolactin levels. More women who smoke believe that they have insufficient milk than non-smokers.
- Mothers who smoke are likely to breastfeed for a shorter length of time.
- Many women continue to smoke whilst breastfeeding perceiving that it is the only time that they have for themselves, to overcome tiredness or to reduce their appetite.
- Passive smoking is related to early onset of wheezing although breastfeeding may reduce the severity of bronchial asthma. Research has shown that babies of mothers who smoke have three times more visits to GP with respiratory and sinus infection and allergy including asthma.
- Research shows exposure to smoke increases the risk of cot death in babies. If the mother and father smoke the risk is multiplied by seven.
- There have been reports linking smoking during breastfeeding with risk of obesity and endocrine dysfunction in the baby in later life.
So, there is no doubt that continuing to smoke whilst breastfeeding is harmful to your baby even if you or your partner don’t smoke in the same room as the baby, maybe even outside. Having said that breastfeeding and smoking still has benefits over not breastfeeding at all.
Behavioural support involves regular meetings with a trained person, usually a smoking cessation advisor. You are more likely to quit and remain as a non-smoker with behavioural support rather than trying to quit alone. The therapy is normally offered weekly for 4 weeks. It has also been called motivational interviewing – to help you stay motivated to quit. Normally the level of carbon monoxide (CO) in exhaled breath will be measured to show that you are quitting and as a positive feedback for you as you see the levels fall.
As an advisor I found on several occasions that I had a positive CO level at the end of the session, despite never having smoked, due to inhalation of second-hand smoke of the clients I was supporting many of whom had “one last cigarette” before the appointment!
How to change the habit of picking up a cigarette
We know that nicotine is highly addictive. However, with NRT there may still be a craving to pick up a cigarette at the times that you have normally smoked. These times may be a routine e.g., after a cup of coffee, after a meal. Think about where you smoke – is it always in the same place e.g., a chair you sit in, outside the kitchen door so in sight or sound of your baby but not with him/her.
It can help to identify when these times are for you and where you tend to smoke. I recommend keeping a diary for a week during which time you can also think about why you have decided to quit – is it for your baby, for your own health, because of the cost? Is it because you think you OUGHT to or have been told you SHOULD do so. If this has happened how do you feel about that? Shoulds and oughts are often hard to maintain. Plan to stop smoking rather than making a rapid decision on the spur of the moment, even with the best of intentions.
Decide how you can change each time you smoke – can you distract yourself for 20 minutes? This is the time it usually takes a craving to subside. Could you wash the floor, sing a song to your baby, make everything ready for the next meal, paint your nails or something else that works for you? If you smoke to give yourself “5 minutes peace” think about how else you could spend that time positively for you even if it is only to wee by yourself!
On the day you decide to stop, you may choose to tell everyone so that you gain their support, or you may want to keep quiet, so no-one tries to tempt you because they haven’t made their own decision. Some people just want to prove how hard it is and set you up to fail. Only you know whether your friends and family will help you or not.
I would also suggest putting the money that you would have spent on cigarettes in a savings box and at the end of 4 weeks or whatever period you decide, treat yourself to something you would have otherwise not been able to afford. Of course, you might choose that to be a family treat but remember it is also rewarding you for beating the addiction and craving. It isnt easy to give up smoking so be proud of yourself.
IF you have a cigarette one day at a point of weakness, be kind to yourself, accept the slip but carry on your intention to stop – one cigarette doesn’t mean you have failed, it is just one cigarette. Don’t stop giving up!
Have strong tasting sweets around to suck – traditionally these are mints but could be anything you like. Also have lots of healthy snacks so you don’t resort to chocolate or high calorie foods instead.
Nicotine Replacement Therapy (NRT) and Breastfeeding
- It is safer to use nicotine replacement therapy whilst breastfeeding than to smoke.
- Babies will be exposed to less nicotine through NRT than through smoking. Smoking produces blood levels of nicotine of 44ng/ml whilst NRT patches produce around 17 ng/ml.
- NRT avoids exposure to the other chemical compounds in tobacco smoke.
- Patches applied over a 24-hour period may produce vivid dreams in the mother; it might be advisable to remove the patch overnight so that the baby is exposed to less during night time feeds.
- NRT products do not cause breastmilk to smell of cigarettes.
- Nicotine gum produces large variations in nicotine levels whilst patches produce a sustained but lower level. If gum is used it should be chewed immediately after feeds to reduce the baby’s exposure. NRT nasal sprays similarly produce rapid high levels and may best be used after feeds.
- Exposure of the baby to NRT products is safer than exposure to cigarettes and with appropriate support may help the mother (and ideally her partner) to quit smoking permanently.
Medications to stop smoking and breastfeeding.
These tablets are not generally advised during breastfeeding but everyone has individual needs and they might be what is right for you.
Champix™ ( Varenicline)
• Varenicline is a partial nicotine agonist used to assist smoking cessation.
• One researcher points out that based on animal data on nicotine, varenicline might interfere with normal infant lung development and recommends against its use in nursing mothers.
• Based on its long half-life, poor protein binding and small molecular weight it is anticipated to transfer to human milk.
• Because no information is available on the use of varenicline during breastfeeding, an alternate drug is preferred, especially while nursing a new-born or preterm infant.
• If used monitor the baby for changes in sleep, changes in feeding, vomiting, constipation.
• For more information https://www.ncbi.nlm.nih.gov/books/NBK501688/
Zyban ™ (Bupropion)
• Limited information indicates that maternal bupropion doses of up to 300 mg daily produce low levels in breastmilk and would not be expected to cause any adverse effects in breastfed infants.
• However, there is little reported use in breastfed new-born infants and case reports of a possible seizure in partially breastfed 6-month-olds.
• If bupropion is required by a nursing mother, it is not a reason to discontinue breastfeeding.
• However, another drug may be preferred, especially while nursing a new-born or preterm infant.
• For more information https://www.ncbi.nlm.nih.gov/books/NBK501184/
Vaping and breastfeeding
A Cochrane review has found the strongest evidence yet that e-cigarettes, also known as ‘vapes’, help people to quit smoking better than traditional nicotine replacement therapies, such as patches and chewing gums.
E-cigarettes have become very popular as a safer alternative to cigarette smoking without exposure to tobacco and substances known to cause detrimental effects including lung cancer.
It was reported that an e-cigarette produced peak blood nicotine levels of 1.3 ng/mL in 19.6 minutes, which is comparable to the levels obtained by a nicotine inhaler (2.1 ng/mL in 32 minutes) and much lower than those obtained by a conventional cigarette (13.4 ng/mL in 14.3 minutes). This study further revealed that the reduction in the desire to smoke is similar to that of a nicotine inhaler but that e cigarettes are better tolerated by users.
The amount of nicotine delivered after 10 puffs of a 16 mg e cigarette is little to none. Based on these findings, it can be concluded that the amount of nicotine that transfers into breast milk after an acute inhalation of an e-cigarette is probably minimal, and comparable to that of a nicotine inhaler. But it is reported that an average e-cigarette user inhales up to 120 puffs/day.
Be proud of yourself – stopping smoking is not easy! Take every day as it comes and celebrate.
- Bullen C, McRobbie H, Thornley S, Glover M, Lin R, Laugesen M. Effect of an electronic nicotine delivery device (e cigarette) on desire to smoke and withdrawal, user preferences and nicotine delivery: randomised cross-over trial. Tob Control. 2010 Apr;19(2):98-103.
- Eissenberg T. Electronic nicotine delivery devices: ineffective nicotine delivery and craving suppression after acute administration. Tob Control. 2010 Feb;19(1):87-88)
- Etter JF, Bullen C. Electronic cigarette: users’ profile, utilization,satisfaction and perceived efficacy. Addiction. 2011 Nov;106(11):2017-2028
- Gov.UK Smokers urged to swap cigarettes for vapes in world first scheme https://www.gov.uk/government/news/smokers-urged-to-swap-cigarettes-for-vapes-in-world-first-scheme
- NHS Digital Statistics on Women’s Smoking Status at Time of Delivery: England Quarter 4, 2020-21
- NHS Stop smoking in pregnancy https://www.nhs.uk/pregnancy/keeping-well/stop-smoking
- NIHR Smoking and Addiction https://evidence.nihr.ac.uk/alert/e-cigarettes-better-than-nicotine-patches-helping-pregnant-women-stop-smoking/
- Tappin D, Sinclair L, Kee F, McFadden M, Robinson-Smith L, Mitchell A et al. Effect of financial voucher incentives provided with UK stop smoking services on the cessation of smoking in pregnant women (CPIT III): pragmatic, multicentre, single blinded, phase 3, randomised controlled trial BMJ 2022; 379 :e071522 doi:10.1136/bmj-2022-071522
- Zhao L et al. Parental smoking and the risk of congenital heart defects in offspring: An updated meta-analysis of observational studies. 2020; RCP. Hiding in plain sight: treating tobacco dependency in the NHS. 2018; Pineless BL et al. Systematic review and meta-analysis of miscarriage and maternal exposure to tobacco smoke during pregnancy. 2014; RCP & RCPCH. Passive Smoking and Children. 2010
I delivered this presentation for Migraine Ireland and will upload it onto YouTube but sharing the powerpoint slides for training purposes. Happy to answer any questions email@example.com
Available on YouTube https://youtu.be/Lg52tht4XwU
I have written quite a lot about IBD and breastfeeding and compiled information on medication and tests https://breastfeeding-and-medication.co.uk/wp-content/uploads/2022/04/IBD-and-breastfeeding-factsheet-June-2021.pdf. The use of medication in pregnancy is not my area of expertise and I am purely providing links to those who know more.
This information is taken from The medicines Use in Pregnancy Site BUMPS https://www.medicinesinpregnancy.org/About-Us/ and is presented here for ease of access for parents and professionals.
Health professionals can consult the team https://uktis.org/contact-us/ but not members of the public.
Further information is also available https://crohnsandcolitis.org.uk/info-support/information-about-crohns-and-colitis/all-information-about-crohns-and-colitis/living-with-crohns-or-colitis/pregnancy-and-breastfeeding
Links to information on medication
Do not stop taking medication without discussing with your GP or IBD team
For many of the medications used to control symptoms of IBD in pregnancy live vaccines (rotavirus and if necessary BCG) should not be given to a baby under 6 months. If rotavirus is given to the baby then the mother should wear gloves during nappy changes for 2 weeks to avoid exposure to live viral fragments shed in faeces. https://breastfeeding-and-medication.co.uk/fact-sheet/live-vaccinations-and-immunosuppressant-medication-taken-by-breastfeeding-mothers
What are the benefits of using a systemic corticosteroid in pregnancy?
Corticosteroids reduce inflammation by stopping the immune system from attacking the body’s tissues. This is important to reduce unpleasant symptoms and prevent long-term damage. It may also lower the chance of some pregnancy problems linked to uncontrolled inflammation, including miscarriage and lower birth weight.
Are there any risks of using a systemic corticosteroid in pregnancy?
Corticosteroid use in early pregnancy has been linked in some (but not all) studies to a higher chance of having a baby with a cleft lip and/or palate. However, it is clear that the vast majority of babies exposed in the womb to systemic corticosteroids are born without these conditions.
Women taking a systemic corticosteroid in pregnancy may have a higher chance of having a preterm birth. However, it is thought likely that at least some of this effect is due to the underlying inflammatory conditions in these women which have themselves been linked to preterm birth.
Are there any alternatives to using a systemic corticosteroid in pregnancy?
Possibly. Other medicines can often be used to treat inflammatory conditions during pregnancy. However, systemic corticosteroids are usually considered to be among the safest options and are often recommended as a first-choice medicine to treat rheumatic and auto-immune disease during pregnancy.
Some women may find that their symptoms improve during pregnancy; if so, their specialist may advise that their medicine(s) can be altered. However, women should not change or stop their medication without speaking to their doctor.
What are the benefits of using azathioprine/mercaptopurine in pregnancy?
Azathioprine and mercaptopurine reduce inflammation by stopping the immune system from attacking the body’s tissues. This is important to reduce unpleasant symptoms and prevent long-term damage. It may also lower the chance of some pregnancy problems linked to uncontrolled inflammation, including miscarriage and lower birth weight. It is also vital for both mother and baby that a transplanted organ continues to function well during pregnancy.
What are the risks of using azathioprine/mercaptopurine in pregnancy?:
There is no evidence that use of azathioprine or mercaptopurine harm the baby if taken in pregnancy.
What are the benefits of taking sulfasalazine in pregnancy?
Sulfasalazine reduces ongoing tissue damage caused by ulcerative colitis, Crohn’s disease, and rheumatoid arthritis. It also controls unpleasant symptoms that can affect quality of life, and can help to prevent the pregnancy complications that have been associated with these illnesses.
Are there any risks of taking sulfasalazine during pregnancy?
There are no concerns that taking sulfasalazine in pregnancy causes problems in the baby and it is routinely prescribed for pregnant women with ulcerative colitis, Crohn’s disease, and rheumatoid arthritis.
Because sulfasalazine can potentially affect folic acid levels, women taking it while trying to conceive and during pregnancy should be prescribed a high dose folic acid supplement.
What are the benefits of using infliximab in pregnancy?
Infliximab helps to stop the immune system from attacking the body. It controls the unpleasant and often disabling symptoms of some autoimmune diseases and helps to prevent ongoing damage to tissues and organs.
What are the risks of using infliximab in pregnancy?
The available data suggests that infliximab is unlikely to affect the baby’s development. There are reports of some babies being born with a low infant birth weight following infliximab exposure. However, it is unclear if this is caused by the drug itself or the underlying illnesses in pregnant women taking infliximab.
What are the benefits of using certolizumab in pregnancy?
Certolizumab reduces inflammation by stopping the immune system from attacking the body’s tissues. This is important to reduce unpleasant symptoms and prevent long-term damage. It may also lower the chance of some pregnancy problems linked to uncontrolled inflammation, including miscarriage and lower infant birth weight. Certolizumab does not easily cross the placenta so only tiny amounts reach the baby. It is therefore not expected to cause problems in pregnancy.
What are the risks of using certolizumab in pregnancy?
There are no known risks. Use of certolizumab has been studied in around 1,400 pregnant women and there is no evidence that it affects the baby’s development.
What are the benefits of using adalimumab in pregnancy?
Adalimumab reduces inflammation by stopping the immune system from attacking the body’s tissues. This is important to reduce unpleasant symptoms and prevent long-term damage. It may also lower the chance of some pregnancy problems linked to uncontrolled inflammation, including miscarriage and lower infant birth weight.
What are the risks of using adalimumab in pregnancy?
Use of adalimumab in pregnancy has been studied in around 1,500 women. There is no suggestion that adalimumab affects the baby’s development, but ongoing data collection is ideally required to confirm this.
What are the benefits of using etanercept in pregnancy?
Etanercept reduces inflammation by stopping the immune system from attacking the body’s tissues. This is important to reduce unpleasant symptoms and prevent long-term damage. It may also lower the chance of some pregnancy problems linked to uncontrolled inflammation, including miscarriage and lower infant birth weight.
What are the risks of using etanercept in pregnancy?
Use of etanercept in pregnancy has been studied in around 1,200 women. There is no suggestion that etanercept affects the baby’s development but ongoing data collection is ideally required to confirm this.
What are the benefits of using ustekinumab in pregnancy?
Ustekinumab helps to stop the immune system from attacking the body. It controls the unpleasant and often disabling symptoms of some autoimmune diseases, and helps to prevent ongoing damage to tissues and organs. It can also reduce the risk of some adverse pregnancy outcomes that have been linked to poorly controlled autoimmune disease, including miscarriage, preterm delivery and low infant birth weight.
Are there any risks of using ustekinumab during pregnancy?
The small amount of data available suggests that ustekinumab is unlikely to harm the baby but further studies are ideally required.
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
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 ™) 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).
- 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
- Rimegepant for preventing migraine NICE TA 906 July 2023 https://www.nice.org.uk/guidance/TA906/history
- Hale TW and Kruscher K Medications and Mothers milk 2023 (online access September 2023)
- E lactancia ( online access September 2023)
- Lactmed https://www.ncbi.nlm.nih.gov/books/NBK563395/ accessed September 2023
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)
This is one of the chapters of the new book about breastfeeding with a chronic condition https://tinyurl.com/mbbebe8x .
Please not there have been changes to the data from the book – update to book on the way
So many people told not to breastfeed or to stop for medication. Hope this changes some of those concepts. Any queries please feel free to email firstname.lastname@example.org
pdf of factsheet available here
I have multiple sclerosis and I receive 1 monthly infusions of Tysabri. I chose to come of the infusions while pregnant and a month after I had my little boy so I could breast feed a little. I received information but I chose not to continue breastfeeding because I felt nobody actually knew the risks of the drug, I take on breast milk. I felt the sample of people taking Tysabri and breast feeding was too little, and I did not want to risk the health of my beautiful little boy. It wasn’t an easy choice to resume my medication and I have had a few emotional moments where I have felt terrible, I couldn’t give my boy the breast milk he deserves.
I have been on various self-injecting disease modifying drugs until 2015 when I had two very serious flare ups. I went to see the MS team and the neurologist was horrified and apologized for letting me get so bad, he said I should have been in better drugs to control my flare ups. I shuffled and had little movement in my legs, my right being worse. It was the first time I had ever had to use a stick. On other occasions my stubbornness would not let me use a stick but this occasion I had no choice, I was extremely bad. I was then but on Tysabri.
I found out I was pregnant mid-June of last year and phoned neurology to say I would not be getting my next treatment and did not want treatment while I was pregnant. The MS nurse said that women during pregnancy don’t tend to have flare ups, they think mainly because of the pregnancy hormones. I know this was the case for my sister. I received conflicting information about the use of amitriptyline while pregnant from neurologists and the obstetricians. During pregnancy I felt fine. Just the usual tiredness (plus my MS aching which meant I couldn’t always sleep) in the first couple of months and then again at the end. I managed to work full time at beamish museum (I’m a project officer helping with the new 1950’s town) until two weeks before my due date.I spoke to the MS nurse while pregnant and she said as soon as I wanted to return to my treatment I was just to ring. I did this after a month of breast feeding. The neurologist believed I would be ok to continuing breast feeding for 6 months but he wasn’t 100 per cent sure. Based on this information I continued breast feeding for another two weeks after a month of breastfeeding, I was going to go longer. After my first infusion but George (my little boy) got a temperature and was out of sorts, quite grumpy, etc. I was perhaps a little paranoid but thought my milk was affected by the
medication. You just want the best for your child, and I was worried I was giving him something awful through my milk.
My next infusion, I had a bad reaction, my body went into shock, my temperature was high, my heart rate and blood pressure went up, but I was shivering and my extremities were freezing. The consultant on call said he’d not seen a reaction like it before but after they gave me something, I’m not sure what and draped me in blankets, I was a got better. I guess my reaction made me feel I kind of did the right choice not continuing breast feeding. The cases studying so far are few and everyone reacts differently to medication. My body might have released the drug into my breast milk more or George’s body might not have been able to take a small amount of the drug.
Although I think I made the right choice it wasn’t an easy choice to stop breast feeding and I have agonized about the choice to resume treatment. I had a few emotional moments, specifically while eating dinner I broke down and my partner had to comfort me (post pregnancy hormones)! I had looked for a local breast milk bank. But there are none, to my knowledge, around here. However, a colleague, who donates to a bank, has recently offered some of her milk which I’ll gladly accept. I agree breast milk is best. I eat really healthy and wish my son could benefit from my healthy diet.
I was undiagnosed and had my first symptoms appear after my first who was breastfed. I still wasn’t diagnosed until after my second child and a second relapse. I was breastfeeding exclusively and after losing my sight amongst other things, I was encouraged to stop breastfeeding, take steroids and start a disease modifying drug asap. Putting my own health second to breastfeeding was one of the most difficult decisions I have had to make. It effected my relationship with my partner as well, but I am thankful I chose to continue. I chose not to and fed until my son was 18 months and then decided to stop after another MRI with contrast showed I was still highly active. I was offered Mavenclad (immunosuppressant chemo drug) and started that. Although I have a wonderful team there was not much confidence in terms of drugs and breastfeeding
I was being investigated for MS pre-birth of my first child, following birth, my symptoms got a lot worse which I just put down to being a new mum, which I have now realised was MS related and is no surprise to me that I was diagnosed soon after giving birth. I had my baby during a heatwave, which my MS is particularly sensitive to. I can only describe the impact as having the life sucked out of me, like I am not the same person. This impact to my state of mind was huge, but was so breastfeeding, a natural aid that I unknowingly, desperately needed at that time. It was such a balancer for me, gave me purpose and was a huge achievement to know I was sustaining the beautiful life that I had grown, it made me so proud.MS diagnosed after my second child in 2013. Had baby number three in 2019. Came off all disease modifying drugs in order to conceive and stayed off for ten months afterwards to breastfeed. I was determined to exclusively breastfeed for three months minimum due to research suggesting it
reduces relapse risk after birth. I managed to exclusive breastfeeding until I started weaning. My (female) neurologist supportive and helped me work out a strategy to breastfeed even discussing potential relapse treatment that could be taken whilst breastfeeding. My experience of feeding though was difficult. My milk came in late (day 5) and I had a lot of shooting pains in the breast after feeding. I wondered if the spinal cord damage I had from MS was having an impact here. When I tried to research it there was zero information on experience of breastfeeding for women with MS and whether spinal cord damage has an impact. This surprised me as MS overwhelmingly affects young women of childbearing age.
Multiple sclerosis (MS) is a condition that can affect the brain and spinal cord, causing a wide range of potential symptoms, including problems with vision, arm or leg movement, sensation or balance.
It’s a lifelong condition but its effects vary widely between individuals. A variety of medication is used to control symptoms. It’s most commonly diagnosed in people in their 20s and 30s, although it can develop at any age. It’s about 2 to 3 times more common in women than men.
The main symptoms may be progressive or include times of remission. They include:
- difficulty walking
- vision problems,
- problems controlling the bladder
- numbness or tingling in different parts of the body
- muscle stiffness and spasms
- problems with balance and co-ordination
Nelson (1988) studied 191 pregnant women in a non-progressive phase of multiple sclerosis. During pregnancy they noted an exacerbation rate of 10%. Over the nine months after birth the rate increased to 34% but in the first three months it was 68%. Of the women studied, 96 breastfed for an average duration of 6.3 months. The rate of exacerbation was not significantly influenced by breastfeeding with a relapse rate of 37.5% compared with 31.5% in those who didn’t feed. However, Langer-Gould (2013) claimed that exclusively breastfeeding for more than two months produces a five-fold benefit in risk to relapse in the first year.
Pisicane (1994) reported that patients with multiple sclerosis were less likely to have been breastfed for a prolonged period with rates of 55% compared with 76.4% of women in a control group (healthy) who were breastfed for longer than seven months.
Multiple sclerosis patients should be told that if they breastfeed it should be exclusive, because this is more likely to be associated with decreased multiple sclerosis disease activity (Coyle 2016). Some studies suggest that breastfeeding, particularly when prolonged (at least four months), reduces risk for multiple sclerosis in the child (Conradi 2013).
Langer-Gould et al (2017) recruited 397 women with newly diagnosed MS and 433 matched controls. Total ovulatory years and the remaining factors that determine it, including gravidity, parity, episodes of amenorrhea, and hormonal contraceptive use, as well as age at first birth, showed no significant association with the risk of MS. However, among women who had live births, a cumulative duration of breastfeeding for ≥15 months was associated with a reduced risk of MS.
Krysko et al (2019) carried out a systematic review and meta-analysis of 24 studies that include 2974 women with multiple sclerosis. She found a 43% reduced rate of postpartum multiple sclerosis relapses in women who were breastfeeding compared with those who were not breastfeeding, with a stronger benefit of exclusive rather than nonexclusive breastfeeding.
- Acute courses of prednisolone, usually 5 days of prednisolone 40mg a day
- Interferon beta 1 a (Avonex ™ – I/M injection once a week, Rebif ™ sub cutaneous 3 times a week) – molecule too large to pass into milk and zero oral bioavailability
- Interferon beta 1 b (Betaferon ™ sub cutaneous injection every other day)- molecule too large to pass into milk and zero oral bioavailabilityPeginterferon (Plegidry™ sub cutaneous injection every 2 weeks)-– molecule too large to pass into milk and zero oral bioavailability
- Glatiramer (Copaxone™)– sub cutaneous injection once a day or three times a week) useful if no response to interferons. It is degraded to amino acids and cannot be measure in plasma. Very low oral bioavailability. New data presented in 2021 has confirmed that it is compatible with breastfeeding https://www.tevapharm.com/news-and-media/latest-news/new-safety-data-on-treatment-with-copaxone-glatiramer-acetate-of-breastfeeding-mothers-who-live-with-r/
- Natalizumab (Tysabri™) – an infusion every 4 weeks – molecular weight 149,000 and oral bioavailability zero. In the Piano study of women with inflammatory bowel disease in pregnancy 8 women received natalizumab while breastfeeding their infants. Among those who received natalizumab or another biologic agent while breastfeeding, infant growth, development or infection rate was no different from infants whose mothers received no treatment (Matro 2018).
- Dimethyl fumarate (Tecfidera™) – a tablet taken twice a day. Ciplea studied 2 mothers and noted limited transfer into milk (RID 0.01% – 0.03%), the amount being too small to be harmful. Monitor breastfed infants for flushing, vomiting, diarrhoea, adequate weight gain, and developmental milestones.
- Ocrelizumab (Ocrevus™) – an infusion every 6 months. No research in breastfeeding but while no levels in milk have been published, it is likely they are low, and that present, is probably not orally bioavailable (Hale 2020).
- Cladribine (Mavenclad™) is for highly relapsing MS. The tablet is taken in two courses. Each treatment course consists of two treatment weeks, one at the beginning of the first month and one at the beginning of the second month. This is then repeated a year later. Normally this doesn’t need to be repeated. Cladribine is not recommended for use in lactation, withhold breastfeeding for a minimum period of 48 hours after the last dose of medication (Hale 2020).
- Teriflunomide (Aubagio™) tablet taken once a day). No studies in breastfeeding and should be avoided.
- high dose methylprednisolone for exacerbations. Cooper (2015) studied a lactating mother receiving intravenous (1000 mg) doses of methylprednisolone on three consecutive days. Whilst the infant was not breastfed, the measured levels in milk were too low to affect a breastfeeding infant. An interruption of 12 hours following IV therapy would virtually eliminate any risk to the baby. So, the mother could breastfeed overnight and dump milk during the day.
- Almas S, Vance J, Baker T et al. Management of multiple sclerosis in the breastfeeding mother. Mult Scler Int. 2016; 2016:6527458.
- Ciplea AI, Datta P, Rewers-Felkins K, Baker T, Gold R, Hale TW, Hellwig K. Dimethyl fumarate transfer into human milk. Ther Adv Neurol Disord. 2020 Oct 31;13:1756286420968414. doi: 10.1177/1756286420968414. PMID: 33193814; PMCID: PMC7607748.
- Conradi S, Malzahn U, Friedemann P, Quill S, Harms L, Bergh F, et al., Breastfeeding is associated with lower risk for multiple sclerosis, MSJ, 2013;19:553–8.
- Cooper SD, Felkins K, Baker TE, Hale TW, Transfer of methylprednisolone into breast milk in a mother with multiple sclerosis, J Hum Lact, 2015May;31(2):237–9.
- Hale TW Medications and Mothers Milk online access
- Krysko KM, Rutatangwa A, Graves J, Lazar A, Waubant E. Association Between Breastfeeding and Postpartum Multiple Sclerosis Relapses: A Systematic Review and Meta-analysis. JAMA Neurol. 2020;77(3):327–338.
- Langer-Gould A, Beaber BE, Effects of pregnancy and breastfeeding on the multiple sclerosis disease course, Clin Immunol, 2013Nov;149(2):244–50.
- Langer-Gould A, Smith JB, Hellwig K, Gonzales E, Haraszti S, Koebnick C, Xiang A. Breastfeeding, ovulatory years, and risk of multiple sclerosis. Neurology (2017); 89 (6): 563-569
- Matro R, Martin CF, Wolf D et al. Exposure concentrations of infants breastfed by women receiving biologic therapies for inflammatory bowel diseases and effects of breastfeeding on infections and development. Gastroenterology. 2018; 155:696-704.
- Nelson LM, Franklin GM, Jones MC, Risk of multiple sclerosis exacerbation during pregnancy and breast-feeding, JAMA, 1988;259(23):3441–3.
- Pisacane A, Impagliazzo N, Russo M, Valiani R, Mandarini A, Florio C, et al., Breast feeding and multiple sclerosis, BMJ, 1994;308:1411–12.
- Specialist Pharmacy Service 2020 https://www.sps.nhs.uk/articles/safety-in-lactation-other-immunomodulating-drugs/
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