Bromocriptine and suppression of breast feeding (lactation)

Seek expert advice.

Bromocriptine should not be routinely used for stopping breast milk production (1).

Cabergoline is simple, effective and generally safe when given to postpartum women either wishing or needing to suppress lactation (2).

Restrictions in use of bromocriptine for stopping breast milk production

European Medicine Agency (EMA) guidance states that the medicine should not be used routinely for preventing or stopping milk production after childbirth (1)

• on 20 August 2014, the Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh)1 endorsed by majority recommendations on the use of bromocriptine-containing medicines by mouth to prevent or suppress breast milk production (lactation) after childbirth
• the CMDh agreed that the medicines should only be used for this purpose (in strengths up to 2.5 mg) when there are compelling medical reasons for stopping lactation, such as the need to avoid further distress after loss of the baby during or just after childbirth, or in mothers with HIV infection, who should not breastfeed
• bromocriptine should not be used routinely for preventing or stopping milk production, and must not be used in women at increased risk of serious side effects, including women with various disorders that increase blood pressure or who have or have had heart disease or severe psychiatric disorders. Blood pressure should be monitored so that early signs of an increase can be detected and treatment stopped immediately
• the CMDh position followed a review by the EMA's Pharmacovigilance Risk Assessment Committee (PRAC) of available data on the safety and effectiveness of bromocriptine in controlling breast milk production after childbirth, which led to these recommendations. The review was triggered by concerns in France over increased reports of rare but potentially serious or fatal side effects, particularly cardiovascular side effects (such as heart attack and stroke), neurological side effects such as seizures (fits) and psychiatric side effects (such as hallucinations and manic episodes). Since lactation is a natural process that eventually stops if the infant is not breastfed, and other means of management are available, the French medicines agency (ANSM) asked the EMA to review the medicines and see if the benefits of such use still outweighed the risks.

As the CMDh position on bromocriptine was adopted by majority vote, it was sent to the European Commission, which took an EU-wide legally binding decision on 30 October 2014.

The UK Medicines and Healthcare products and Regulatory Agency (MHRA) states (3):

• Advice for healthcare professionals:
  • bromocriptine should only be prescribed to suppress post-partum physiological lactation, where it is medically indicated such as intrapartum loss, neonatal death, or in some cases of HIV infection of the mother
  • bromocriptine should not be used for routine lactation suppression, or for relieving symptoms of postpartum breast pain and engorgement, which can be adequately treated with non-pharmacological interventions (such as firm breast support, ice application) and simple analgesics
  • use is contraindicated for patients with uncontrolled hypertension, hypertensive disorders of pregnancy (including eclampsia, pre-eclampsia or pregnancy-induced hypertension), hypertension post-partum and in the puerperium, a history of coronary artery disease or other severe cardiovascular conditions
  • particular caution is required in patients who are on concomitant therapy or recent treatment with drugs that can alter blood pressure
  • when prescribing bromocriptine for any of its indications, carefully monitor for an increase in blood pressure, especially during the first days of therapy and with any subsequent dose increases
  • if patients prescribed bromocriptine present with signs and symptoms of hypertension, treatment should be discontinued, and the patient evaluated promptly by healthcare professional
  • clinical guidance recommends cabergoline as the preferred drug for prevention or inhibition of post-partum physiological lactation, owing to the single dose regime and lower rates of rebound breast activity and adverse events. However, blood pressure monitoring is still necessary when taking cabergoline as both cabergoline and bromocriptine are dopamine agonists and should not be given to women with hypertension or pre-eclampsia
  • healthcare professionals are encouraged to read the Summary of Product Characteristics (SmPC) for special warnings and contraindications for the use of bromocriptine and cabergoline
  • report suspected adverse drug reactions to bromocriptine or cabergoline to the Yellow Card scheme

The summary of product characteristics should be consulted before prescribing the drugs described

Reference:

1. European Medicines Agency. Bromocriptine-containing medicines indicated in the prevention or suppression of physiological lactation post-partum
2. Yang Y, Boucoiran I, Tulloch KJ, Poliquin V. Is Cabergoline Safe and Effective for Postpartum Lactation Inhibition? A Systematic Review. Int J Womens Health. 2020 Mar 9;12:159-170. doi: 10.2147/IJWH.S232693. PMID: 32210637; PMCID: PMC7069562
3. MHRA Safety Update volume 18, issue 3: October 2024: 3