Bromocriptine: monitor blood pressure when prescribing bromocriptine for prevention or inhibition of post-partum physiological lactation

A safety review has been conducted by the MHRA following a Yellow Card report concerning a patient who was taking bromocriptine. The review concluded that blood pressure monitoring of patients prescribed with this drug is essential especially during the first days of treatment.

From:
Medicines and Healthcare products Regulatory Agency
Published
24 October 2024
Therapeutic area:
Breastfeeding, Dispensing GP practices, Obstetrics, gynaecology and fertility, Pregnancy

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 professionals

  • clinical guidance[footnote 1] 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

Advice for healthcare professionals to provide to patients:

  • bromocriptine is used to prevent or stop milk production after childbirth in women who are not breastfeeding only if there are medical reasons for doing so, for example to avoid further distress in women who lose a baby during or just after birth, or in some cases of HIV infection of the mother

  • inform your doctor if you had blood pressure problems before or during pregnancy or after giving birth, such as eclampsia, pre-eclampsia, pregnancy-induced high blood pressure or high blood pressure after giving birth

  • your doctor will need to check your blood pressure regularly during the first few days of treatment with bromocriptine

  • seek urgent medical attention if you experience symptoms of high blood pressure, for example chest pain or unusually severe or persistent headache, with or without vision problems while taking bromocriptine

  • report suspected adverse drug reactions to the Yellow Card scheme

Background

The MHRA has received a Yellow Card report which highlighted the need for blood pressure monitoring during bromocriptine treatment, especially during the first days of therapy. It is imperative that signs and symptoms of hypertension are recognised in patients receiving bromocriptine. Treatment with bromocriptine should be discontinued in hypertensive patients or when signs and symptoms of hypertension are detected and the patient promptly evaluated with consideration given as to whether they should be referred for further investigation and management of high blood pressure or close monitoring.

Bromocriptine is a dopamine agonist which inhibits the release of prolactin by the pituitary gland and induces a cyclic and physiologic oestrogen secretion. Bromocriptine is indicated for the prevention or suppression of post-partum physiological lactation only where medically indicated (such as in case of intrapartum loss, neonatal death or in some cases of HIV infection of the mother).

Bromocriptine is not recommended for the routine suppression of lactation or for the relief of symptoms of post-partum pain and engorgement which can be adequately treated with non-pharmacological interventions (such as firm breast support, ice application) and simple analgesics.

Other indications for bromocriptine include hyperprolactinaemia, menstrual cycle disorders and female infertility, premenstrual symptoms and benign breast disease, prolactinomas, acromegaly and Parkinson’s disease. Blood pressure monitoring is required when bromocriptine is used for any of its indications.

Clinical Guidelines

The Royal College of Obstetricians and Gynaecologists’ Guidance on Late Intrauterine Fetal Death and Stillbirth,[footnote 1] Section 7.3, refers to use of both bromocriptine and cabergoline for lactation suppression but recommends cabergoline, as the single dose regime is easier to use and has shown significantly lower rates of rebound breast activity and adverse events.

Blood pressure should be carefully monitored during treatment with either bromocriptine or cabergoline, and use of these medications is contraindicated in patients with existing high blood pressure.

The Summary of Product Characteristics (SmPC) for both bromocriptine and cabergoline details the indications, contraindications as well as the precautionary warnings of blood pressure monitoring.

Reporting Advice

Please report any suspected adverse drug reactions through the Yellow Card scheme. Healthcare professionals, patients, and caregivers are asked to submit reports using the Yellow Card scheme electronically using:

When reporting suspected adverse drug reactions, please provide as much information as possible, including information about medical history, any concomitant medication, onset timing, and treatment dates.

For queries or more information, please contact info@mhra.gov.uk

Article citation: MHRA Safety Update volume 18, issue 3: October 2024: 3

References

  1. Royal College of Obstetricians and Gynaecologists (RCOG) guidance on Late Intrauterine Fetal Death and Stillbirth; gtg_55.pdf (rcog.org.uk) ↩ ↩2

Updates to this page

Published 24 October 2024
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