General considerations

It is important to complete an individual risk assessment for your patient and to apply the principles of prescribing in breastfeeding 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, 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

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), 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.

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