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Lithium and valproate can be used during breastfeeding, after consideration of some specific issues. Recommendations apply to full term and healthy infants.

General considerations

It is important to complete an individual risk assessment (SPS page) for your patient and to apply the principles of prescribing in breastfeeding (SPS page) when looking at the available information and making treatment decisions.

Valproate is an umbrella term used to describe the various forms of valproic acid. This article uses the term ‘valproate’ for both valproic acid and sodium valproate.

Recommendations

Valproate can be used during breastfeeding in the management of bipolar disorder.

Valproate can also be used in the management of epilepsy in breastfeeding.

Lithium can also be used for the management of bipolar disorder, but must be with extreme caution, under specialist supervision, and with strict infant monitoring conditions.

Clinical Considerations

A variety of other medicines may also be used to manage bipolar disorder, including antipsychotics, and antidepressants such as SSRIs.

These medicines may need to be added in various combinations for more specialist situations. Contact UKDILAS, our specialist service (SPS page), for further advice.

Treatment choice should primarily focus on controlling the mother’s symptoms. Safety in breastfeeding is a secondary consideration.

It is important that the mother receives effective treatment and does not stop taking the medicines suddenly.

Pregnancy Prevention Programme

The MHRA advise that valproate should not be used in women of child bearing age unless a Pregnancy Prevention Programme is in place, and only if other treatments are ineffective or not tolerated.

Long-term exposure

There are limited data on the neurodevelopmental effects of long-term exposure to these medicines during breastfeeding.

Specific recommendations

Use with caution

Lithium must be used with extreme caution, under specialist supervision, and strict infant monitoring conditions apply.

Infant monitoring

Monitor infant for lethargy, poor feeding and adequate weight gain, changes in behaviour, diarrhoea, vomiting, hypotonia, tremor, breathing difficulties, and attainment of developmental milestones.

Side effects and potential toxicity are more likely to occur if the infant is dehydrated or has an infection. Signs of dehydration include fewer wet nappies and dry mouth; signs of infection include irritability, high temperature, and sweating.

Infant lithium levels will be required, but exactly when these should be taken and how frequently will depend on many factors including whether the infant was exposed to lithium during pregnancy and how often the infant is being fed. In addition, infant thyroid and renal function should also be checked. Contact UKDILAS, our specialist service (SPS page), for further advice.

Further information

Lithium passes into breastmilk in varying amounts (0.87% to 42% of the weight-adjusted maternal lithium dose). However, the higher levels reported have been in older, poor quality case reports in which there was questionable analysis of the milk samples. Similarly, there has been huge variability in the infant serum levels reported.

Numerous breastfed infants have had no side effects, signs of toxicity, or development problems. Where side effects have been reported, these have usually been complicated by additional factors, such as the infant also being exposed to a diuretic or concurrent infection which may have contributed to dehydration.

Use with caution

Valproate can be used with caution during breastfeeding. Infant monitoring is required.

Infant monitoring

Monitor infant for drowsiness, poor feeding and adequate weight gain, changes in behaviour, signs of jaundice, bruising and bleeding more easily, and attainment of developmental milestones.

Further information

There is significant published evidence of use during breastfeeding. Very small amounts are found in breast milk.

The MHRA advise that valproate should not be used in women of child bearing age unless a Pregnancy Prevention Programme is in place, and only if other treatments are ineffective or not tolerated.

Patient Information

The NHS website provides advice for patients on the use of specific medicines in breastfeeding.

Contact us

Get in touch with the UK Drugs In Lactation Advisory Service (UKDILAS) (SPS page), our specialist breastfeeding medicines advice service if you need support in the following situations:

  • you need further advice
  • the medicine in question is not included here
  • the infant is unwell or premature
  • multiple medicines are being taken

About our recommendations

Recommendations are based on published evidence where available. However, evidence is generally very poor and limited, and can require professional interpretation. Assessments are often based on reviewing case reports which can be conflicting and lack detail.

If there is no published clinical evidence, assessments are based on: pharmacodynamic and pharmacokinetic principles, extrapolation from similar drugs, risk assessment of normal clinical use, expert advice, and unpublished data. Simulated data is now increasingly being used due to the ethical difficulties around gathering good quality evidence in this area.

Bibliography

Full referencing is available on request.

Update history

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