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Tirzepatide  (Mounjaro™) and Breastfeeding

Tirzepatide is a long-acting GIP (glucose-dependent insulinotropic polypeptide) receptor and GLP-1 (glucagon-like peptide-1) receptor agonist that increases insulin sensitivity and secretion, suppresses glucagon secretion, and slows gastric emptying.

Tirzepatide is used to treat Type 2 diabetes mellitus as monotherapy (if metformin is inappropriate), or in combination with other antidiabetic drugs (including insulin) if existing treatment fails to achieve adequate glycaemic control. It is also used in the treatment of obesity by weekly subcutaneous administration.

No information is available on the clinical use of tirzepatide during breastfeeding. Because tirzepatide is a large peptide molecule with a molecular weight of 4814 Da, the amount in milk is likely to be low and absorption is unlikely because it is probably partially destroyed in the infant’s gastrointestinal tract. Until more data become available, tirzepatide should be used with caution during breastfeeding, especially while nursing a newborn or preterm infant. (LactMed).

Due to its protein nature, it is inactivated in the gastrointestinal tract and is not absorbed (oral bioavailability is practically nil), which makes it difficult or impossible for it to pass into the infant’s plasma from ingested breast milk, except in premature infants and in the immediate neonatal period, where there may be greater intestinal permeability. (E-lactancia).

While caution is still necessary without confirmatory data, it is unlikely to be present in large quantities in the milk compartment (Hale )

See also https://www.infantrisk.com/content/weight-loss-lactation

Hale and Krutsch (Infantrisk pharmacists express concern on the use of weight loss medications and breastfeeding due to inadequate consumption of nutrients.

“Concerns have been expressed about how the pharmacodynamics of GLP-1 agonists such as tirzepatide or semaglutide could impact the nutritional constituents of milk. These drugs are analogs of natural GLP-1 with small modifications to slow their degradation by the DPP-4 enzyme. However, lactation, in general, is expected to occur during a catabolic physiological state – GLP-1 agonists catalyze the catabolism to encourage weight loss. As long as the mother has sufficient weight to lose, the nutrient profile of milk would likely be similar if compared to a diet producing equivalent weight loss. If a mother is reducing caloric intake for any reason, we recommend a postnatal vitamin and attention to consuming enough calories to meet the elevated nutrient needs required during lactation”.

Other sources of information

NICE  TA 1026 Tirzepatide for managing overweight and obesity . https://www.nice.org.uk/guidance/ta1026

See also Semaglutide and Breastfeeding https://breastfeeding-and-medication.co.uk/fact-sheet/semaglutide-and-breastfeeding

Liraglutide and Breastfeeding https://breastfeeding-and-medication.co.uk/fact-sheet/liraglutide-saxenda-and-breastfeeding

ADHD and Breastfeeding

I have shared the chapter on ADHD from my book Breastfeeding and Chronic Medical Conditions multiple times this week. Many mothers seem to be diagnosed in later life and are concerned about breastfeeding. Hope this is a useful link.

More information

ADHD and Breastfeeding Factsheet

If this is useful maybe you need the book available on Amazon. I published on Kindle to try to make this more affordable and available to mothers and breastfeeding supporters as well as professionals

https://infantrisk.com/content/adhd-medications-and-breastfeeding

I came off my medication to conceive and my baby is now 6 months old. I am really struggling to think straight now and getting really overwhelmed by the smallest of things.

Description

ADHD is a disorder that includes symptoms such as inattentiveness, hyperactivity, and impulsiveness. It is normally diagnosed in childhood, but some parents have found themselves being diagnosed when seeking a diagnosis for their children. The cause is unknown, but it seems to at least in part, genetic. It has been suggested that being born prematurely (before the 37th week of pregnancy), having a low birth weight or maternal smoking or alcohol or drug abuse during pregnancy may be linked. Attention deficit hyperactivity disorder (ADHD) is thought to affect about 1 in 20 children in the UK with incidence being three times higher in boys.

Symptoms fall into 2 categories:

inattentiveness main symptoms of which are:

  • having a short attention span and being easily distracted
  • making careless mistakes
  • appearing forgetful or losing things
  • being unable to stick to tasks that are tedious
  • appearing to be unable to listen to or carry out instructions
  • constantly changing activity or task
  • having difficulty organising tasks

hyperactivity and impulsiveness main symptoms of which are:

  • being unable to sit still and constantly fidgeting
  • being unable to concentrate on tasks
  • excessive physical movement
  • excessive talking
  • being unable to wait turn
  • acting without thinking
  • interrupting conversations
  • little or no sense of danger
  • ADHD may be linked with anxiety, autism, and several other conditions. By the age of 25, an estimated 15% of people diagnosed with ADHD as children still have a full range of symptoms, and 65% still have some symptoms that affect their daily lives. ( https://www.nhs.uk/conditions/attention-deficit-hyperactivity-disorder-adhd/symptoms/)

Treatment

  •        Methylphenidate (Ritalin ™, Concerta ™); works by increasing the amount of a dopamine in the parts of the brain responsible for self-control and attention. It is usually the first line treatment. There are side effects of loss of appetite and difficulty sleeping and mood swings. Limited evidence indicates that methylphenidate levels in milk are very low and not detectable in infant serum. The effects of methylphenidate in milk on the neurological development of the infant have not been well studied. Monitor the baby for agitation, irritability, poor sleeping patterns, changes in feeding and poor weight gain.
  •         Atomexatine is a selective noradrenaline reuptake inhibitor (SNRI), increasing levels of noradrenaline rather than dopamine. It can aid concentration and help control impulses. Side effects include rise in blood pressure and heart rate, nausea and vomiting, gastric pain, difficulty sleeping, dizziness, headaches, and irritability. More importantly it has been associated with suicidal thoughts and liver damage. There is no published experience with atomoxetine during breastfeeding, although reports from the manufacturer found no serious adverse effects in two breastfed infants (Besag 2014).
  •         Dexamphetamine. Side effects include decreased appetite, mood swings, agitation and aggression, dizziness, headaches, nausea, vomiting and diarrhoea. Only used if lisdexamphetamine is helpful but not tolerated. In dosages prescribed for medical indications, some evidence indicates that dextroamphetamine might not affect nursing infants adversely. The effect of dextroamphetamine in milk on the neurological development of the infant has not been well studied. It is possible that large dosages of dextroamphetamine might interfere with milk production.  Infant Monitoring for agitation, hyperactivity, insomnia, decreased appetite, weight gain, and tremor.
  •         Lisdexamphetamine (Vyvance ™) may be offered as first line treatment in adults. Side effects include decreased appetite, aggression or drowsiness, dizziness, headaches, nausea, vomiting and diarrhoea. Lisdexamfetamine is a prodrug of dextroamphetamine. In medicinal dosages, some evidence (5 mothers studied) indicates that dextroamphetamine might not affect nursing infants adversely. The effect of dextroamphetamine in milk on the neurological development of the infant has not been well studied. Infant Monitoring should be for agitation, irritability, poor sleeping patterns and poor weight gain.
  • The NHS website suggests that for adults with ADHD if you find it hard to stay organised, then make lists, keep diaries, stick up reminders and set aside some time to plan what you need to do
  • let off steam by exercising regularly
  • find ways to help you relax, such as listening to music or learning relaxation techniques
  • if you have a job, speak to your employer about your condition, and discuss anything they can do to help you work better
  • talk to your doctor about your suitability to drive, as you will need to tell the Driver and Vehicle Licensing Agency (DVLA) if your ADHD affects your driving
  • contact or join a local or national support group – these organisations can put you in touch with other people in a similar situation, and can be a good source of support, information, and advice

References

  • Attention deficit hyperactivity disorder: diagnosis and management; NICE guideline (March 2018, updated September 2019)
  • Attention deficit hyperactivity disorder; NICE CKS, May 2018
  • Besag FM. ADHD treatment and pregnancy. Drug Saf. 2014; 37:397-40
  • NHS ADHD https://www.nhs.uk/conditions/attention-deficit-hyperactivity-disorder-adhd/living-with/
  • Further Information
  • AADUK https://aadduk.org/

Can women with ADHD stay on medication while they breastfeed?

Anecdotally there are many mothers who take medication for ADHD during their breastfeeding journey despite a lack of published studies on the effect of the level of medication passing through breastmilk to babies. It is a topic regularly raised on social media discussions from which many parents take their information. Since the pandemic the increase in diagnoses of adults has driven the discussions too.

As with many drugs we rely on the pharmacokinetics of the products: that is the way that the drugs are handled by the body. Drugs used to treat ADHD are not recommended during breastfeeding as the manufacturers are not required to take responsibility as they cannot ethically conduct clinical trials during the development of the medication. This is true of virtually all products used by breastfeeding women – they are used outside of the product licence and prescribed with the professionals being required to take responsibility.

For example methylphenidate (Concerta™ and Ritalin™) was studied in 3 women taking between 35 and 80mg daily. The average milk levels measured were very low.  The infants had no drug-related adverse reactions and were developing normally for their ages which averaged 4.4 months. No adverse events have been identified according to specialist sources although it would be wise to monitor changes in sleep patters and feeding including weight gain.

What ones are safest?

It is difficult to say which one is “safest” as this is a relative term. No drug is absolutely safe, but all of the drugs used to treat ADHD are recognised as compatible with breastfeeding by expert, specialist sources. The drug which would generally be chosen is the one that has proven to be most effective for the mother. Methylphenidate could perhaps be said to have the best evidence but as has already been discussed, the data published is limited. The decision to prescribe should be agreed between the mother and her professionals with full, accessible information so that she can make an informed choice in the risks and benefits for her and her nursling. Ongoing breastfeeding has many health advantages but if the mother has concerns about exposing her child to the medication (in however low a level) that may influence her choice as to whether to take the drug and continue to breastfeed, breastfeed but delay the drug or take the medication and choose to formula feed. We all have individual feelings as to the risks and benefits of each choice.

Is there a risk to the baby at all?

In the first 6 weeks after birth a baby has immature kidney and liver function and is at greater risk of not being able to metabolise the levels of drug passing through breastmilk. This in turn makes it more likely that side effects such as changes in sleep and feeding patters may occur but are difficult to identify from normal neonatal behaviour.

Individual reactions are always possible although reporting in specialist expert sources suggest these are limited.

Is it advised to stay on rather than coping without it?

That is very much an individual decision depending on how well the mother is coping with her symptoms alongside the complexity of life with a newborn which will all be associated with loss of routine and long periods sitting to breastfeed. Most mothers stop medication during pregnancy and may be desperate to re start. A fully informed discussion with appropriate, accessible data puts the decision with the mother on what she feels comfortable with.

Specialist sources of information

https://www.ncbi.nlm.nih.gov/books/NBK501922

https://www.e-lactancia.org

https://www.infantrisk.com/content/adhd-medications-and-breastfeeding#:~:text=It%20is%20rare%20that%20a,breastfeeding%20to%20take%20a%20medication.&text=Multiple%20studies%20have%20demonstrated%20that,her%20ADHD%20medication%20as%20prescribed.

https://www.sps.nhs.uk/articles/safety-in-lactation-drugs-for-adhd

H Pylori and Breastfeeding

Helicobacter pylori (H. pylori) infection is one of the most common causes of peptic ulcer disease, with 95% of duodenal and 70–80% of gastric ulcers associated with it.

Treatment aims to eradicate H. pylori with a relatively short course of 2 high dose antibiotics together with a proton pump inhibitor (PPI) drug such as such as esomeprazole, lansoprazole, omeprazole, pantoprazole, or rabeprazole sodium.  Combinations of drugs may vary.

These are the options given in the British National Formulary (BNF).

No penicillin allergy

Oral first line for 7 days:

  • A proton pump inhibitor, plus amoxicillin, and either clarithromycin or metronidazole (treatment choice should take into account previous treatment with clarithromycin or metronidazole).

If this fails to resolve the infection other treatments are available.

Penicillin allergy

Oral first line for 7 days:

  • A proton pump inhibitor, plus clarithromycin, and metronidazole.

If this fails to resolve the infection other treatments are available.

Safety in breastfeeding.

PPI:  esomeprazole, lansoprazole, omeprazole, pantoprazole, or rabeprazole sodium are largely destroyed in the mother’s stomach. Several of them have enteric coated pellets within capsules to protect them before appropriate release.

  • Omeprazole (20-40mg) is only 30-40% orally bioavailable and has RID 1.1%. Preferred PPI
  • Esomeprazole (20mg) is 90% orally bioavailable and has RID 2.06%. After 8 hours levels in breastmilk below level of detection
  • Lansoprazole (30mg) 80%  orally bioavailable (enteric coated) and is very unstable in gastric acid
  • Pantoprazole (40mg) is 77% orally bioavailable (enteric coated) and RID 1% with milk levels undetectable after 5 hours
  • Rabeprazole (20mg) is 52% orally bioavailable (enteric coated) and unstable in gastric acid

Antibiotics ( see https://breastfeeding-and-medication.co.uk/fact-sheet/antibiotics-and-breastfeeding)

  • Amoxycillin: licensed for paediatric use. Dose 1g twice daily
  • Clarithromycin: licensed for paediatric use 250mg or 500mg twice daily
  • Metronidazole: 400mg twice daily. Studies show no untoward effects at this dose although there are some dated reports that it affects taste of the milk. Most babies do not react and it is widely used for anaerobic infections in the perinatal period and for dental infections.

H. Pylori infection treatment as above is compatible with continued breastfeeding. For any variations please contact me wendy@breastfeeding-and-medication.co.uk

Oral Morphine and Breastfeeding

Morphine is an opioid analgesic (painkiller) prescribed when paracetamol and ibuprofen provide inadequate pain relief. Other opioid painkillers include codeine (not recommended in breastfeeding but see https://breastfeeding-and-medication.co.uk/fact-sheet/accidental-dose-of-codeine-when-breastfeeding ), dihydrocodeine ( see https://breastfeeding-and-medication.co.uk/fact-sheet/dihydrocodeine-and-breastfeeding) , oxycodone ( see  https://breastfeeding-and-medication.co.uk/fact-sheet/oxycodone-and-breastfeeding) and Tramadol (see https://breastfeeding-and-medication.co.uk/fact-sheet/tramadol-and-breastfeeding) See also  https://breastfeeding-and-medication.co.uk/fact-sheet/pain-relief-when-breastfeeding. All of these drugs can cause constipation so should be prescribed with a suitable laxative ( https://breastfeeding-and-medication.co.uk/fact-sheet/constipation-laxatives-and-breastfeeding) .

Therapeutic doses of morphine in the breastfeeding mother are unlikely to be harmful to baby in short term e.g. post-operatively because morphine is subject to extensive first pass metabolism. Respiratory difficulties may be important to be aware of with premature babies or others at risk of apnoea. The oral absorption of morphine is very poor and first pass metabolism is high. It is therefore frequently used post caesarean section as Oramorph solution.

Robieux et al. (1990) reported a single case of an infant who was breastfed while his mother was receiving low doses of morphine. Morphine concentration in his serum was in the analgesic range (4 ng per millilitre), while concentrations in the milk varied substantially from 10–100 ng per millilitre. The authors calculated that the baby had received 0.8 to 12% of maternal dose. Oberlander et al. (2000) studied one baby born to a mother who received morphine intra-thecally during and after pregnancy. Minimal levels were determined in breastmilk over 7 weeks and the infant’s development and feeding up to 7 months were normal. Baka et al. (2002) also studied women receiving patient controlled analgesia post-caesarian section and noted that the concentrations of morphine in breastmilk were very small (<1 to 274 ng per millilitre) with a m/p ratio <1. Relative infant dose quoted as 9.1% (Hale  online access).

Therapeutic doses unlikely to affect infant (BNF).

Compatible with use short term during breastfeeding. Observe baby for sedation and poor feeding. As with other opiates, exposure of premature infants should be undertaken with caution because of the risk of apnoea and sedation.

The amount in breastmilk is probably too small to be harmful. The dose should be as low as possible for as short a period as possible as with all opioid medication and titrated down to paracetamol and NSAID once pain relief is adequate. Observe baby for drowsiness. If baby becomes drowsy stop drug immediately and seek medical advice.

References

  • Ilett KF, Paech MJ, Page-Sharp M, Sy SK, Kristensen JH, Goy R, Chua S, Christmas T, Scott KL, Colostrum morphine concentrations during postcesarean intravenous patient-controlled analgesia, Anesth Analg, 2002;94:184–7.
  • Oberlander TF, Robeson P, Ward V, Huckin RS, Kamani A, Harpur A, McDonald W, Prenatal and breastmilk morphine exposure following maternal intrathecal morphine treatment, J Hum Lact, 2000;16:137–42.
  • Robieux I, Koren G, Vandenbergh H, Schneiderman J, Morphine excretion in breastmilk and resultant exposure of a nursing infant, J Toxicol Clin Toxicol 1990
  • Hale T, Krutsch K.  Hale’s Medications & Mothers’ Milk 2025-2026

Tramadol and Breastfeeding

Tramadol is an opioid analgesic (painkiller) prescribed when paracetamol and ibuprofen provide inadequate pain relief. Other opioid painkillers include codeine (not recommended in breastfeeding but see https://breastfeeding-and-medication.co.uk/fact-sheet/accidental-dose-of-codeine-when-breastfeeding ), dihydrocodeine ( see https://breastfeeding-and-medication.co.uk/fact-sheet/dihydrocodeine-and-breastfeeding) , oxycodone ( see Oxycodone and Breastfeeding – Breastfeeding and Medication)  and morphine  ( https://breastfeeding-and-medication.co.uk/fact-sheet/pain-relief-when-breastfeeding). All of these drugs can cause constipation so should be prescribed with a suitable laxative ( https://breastfeeding-and-medication.co.uk/fact-sheet/constipation-laxatives-and-breastfeeding) .

Brand name: Zydol®, Zamadol®

Tramadol is an opiate analgesic used for moderate to severe pain. It is subject to first pass metabolism which limits passage into milk. It has an elimination half-life of 6 hours. Tramadol inhibits the reuptake of noradrenaline and serotonin and may potentiate the action of other drugs with similar action e.g. SSRI anti-depressants.

Ilett et al. (2008) studied 75 breastfeeding mothers who were given 100 mg tramadol post-caesarian section on days 2 to 4. He collected milk and plasma samples of four or more doses to reflect steady state. Additionally, he observed the infants together with matched controls not exposed to tramadol. He determined a relative infant dose quoted as 2.24% for tramadol and 0.64% for its metabolite. No difference was noted in the behaviours of the infants exposed compared with the controls and the authors therefore concluded that short-term maternal use of tramadol is compatible with breastfeeding.

Tramadol is metabolized in the liver by enzyme cytochrome P450 isoenzyme 2D6 (CYP2D6). Some people have a variation of this enzyme that changes codeine to morphine and tramadol to M1 faster and to a greater extent than in other people. These individuals are called CYP2D6 ultra-rapid metabolizers. Just as in codeine this can produce an accumulation of the drug in breastmilk. This genotype is present in up to 10% of the white population in Europe and North America, but only 4% of black African Americans (FDA 2015).

As with other opiates, exposure of premature infants should be undertaken with caution because of the risk of apnoea and sedation.

The amount in breastmilk is probably too small to be harmful. The dose should be as low as possible for as short a period as possible as with all opioid medication and titrated down to paracetamol and NSAID once pain relief is adequate. Observe baby for drowsiness. If baby becomes drowsy stop drug immediately and seek medical advice.

References

  • Ilett KF, Paech MJ, Page-Sharp M, Sy SK, Kristensen JH, Goy R, Chua S, Christmas T, Scott KL, Use of a sparse sampling study design to assess transfer of tramadol and its o-desmethyl metabolite into transitional breastmilk. Br J Clin Pharmacol, 2008;65(5):661–6
  • Hale T, Krutsch K.  Hale’s Medications & Mothers’ Milk 2025-2026

Oxycodone and Breastfeeding

Oxycodone is an opioid analgesic (painkiller) prescribed when paracetamol and ibuprofen provide inadequate pain relief. Other opioid painkillers include codeine (not recommended in breastfeeding but see https://breastfeeding-and-medication.co.uk/fact-sheet/accidental-dose-of-codeine-when-breastfeeding ), dihydrocodeine ( see https://breastfeeding-and-medication.co.uk/fact-sheet/dihydrocodeine-and-breastfeeding) , tramadol and morphine  . ( https://breastfeeding-and-medication.co.uk/fact-sheet/pain-relief-when-breastfeeding). All of these drugs can cause constipation so should be prescribed with a suitable laxative ( https://breastfeeding-and-medication.co.uk/fact-sheet/constipation-laxatives-and-breastfeeding) .

Brand name: OxyContin, OxyNorm

Oxycodone is an opiate used for severe pain often post operatively. It is suggested that it is associated with more sedation than other opiates. Timm (2013) reported on a 4-day-old breastfed infant who was taken to the emergency department with symptoms indicating opioid intoxication resulting from his mother’s use of oxycodone after caesarean delivery. The infant was hypothermic, lethargic, and had pinpoint pupils. A dose of naloxone reversed the symptoms and the baby fed. The mother discontinued oxycodone and the baby was discharged without further pathology.

Seaton (2007) studied fifty breast-feeding mothers taking oxycodone following caesarean section. Blood and breast milk samples were analysed and forty-one neonates had blood samples taken at 48 hours. Oxycodone was detected in the milk of mothers who had taken any dose in the previous 24 hours. The authors concluded that Oxycodone is concentrated in human breast milk up to 72 hours after delivery and that infants may receive > 10% of a therapeutic infant dose. However, maternal oxycodone intake up to 72-h post section poses only minimal risk to the breast-feeding infant as low volumes of breast milk are ingested during this period.

Whilst it may be suitable as an analgesic short-term post operatively a breastfed infant should be monitored carefully for sedation and breathing difficulties. Studies appear to relate largely to use in the immediate post-partum period at a dose of 5-10mg as necessary to a maximum of 40mg in 24 hours. The dose should be as low as possible for as short a period as possible as with all opioid medication. and titrated down to paracetamol and NSAID once pain relief is adequate.

Hale reports a half-life of 2-4 hours so normally the drug would be assumed to have left the body after 20 hours. The milk plasma level exceeds 1 (3.4) but the oral bioavailability is 60-87% which explains the relative infant dose of 1.01% – 8%

Observe baby for sedation and poor feeding.

References

  • Seaton S, Reeves M, McLean S. Oxycodone as a component of multimodal analgesia for lactating mothers after Caesarean section: Relationships between maternal plasma, breast milk and neonatal plasma levels. Aust N Z J Obstet Gynaecol. 2007;47:181-5.
  • Timm NL. Maternal use of oxycodone resulting in opioid intoxication in her breastfed neonate. J Pediatr. 2013;162:421-2.
  • Hale T, Krutsch K.  Hale’s Medications & Mothers’ Milk 2025-2026

Text taken from Breastfeeding and Medication 2nd ed 2017 Jones W (Routledge)

Folic Acid and Breastfeeding

Folic acid is a water-soluble vitamin of the B group. It is found naturally in green vegetables, legumes and citric fruits. It is actively secreted in breast milk with concentration higher in mature milk compared to colostrum (Cooperman JM, Dweck HS, Newman LJ, Garbarino C, Lopez R. The folate in human milk. Am J Clin Nutr. 1982;36(4):576-580).

Folic acid 400 micrograms per day is recommended in the first 12 weeks of pregnancy to prevent neural tube defects. If the mother is on anti-epileptic medication, is obese (BMI >30), has a history of neural tube defects in a previous pregnancy, has coeliac disease, diabetes, sickle cell anaemia, thalassaemia, she or her partner have spinal cord defects, the dose should be increased to 5 mg daily.

If the mother is continuing to breastfeed an older baby, she can take the dose of folic acid to protect the unborn baby. No harmful effects have been observed by taking folic acid during lactation (https://e-lactancia.org/breastfeeding/folic-acid/product/). Excess of folic acid is eliminated by the kidneys every day.

Mass media campaigns have been successful in increasing folate awareness but in no study has the post-campaign rate of folic acid use exceeded 50%. It has been recommended that all women of childbearing age should take folic acid regularly on the assumption that they might become pregnant (NICE PH11). Currently neural tube defect affected pregnancies arise in 0.8 per 1000 pregnancies, which translates to 800 pregnancies each year in the UK.

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