其 他 安 全 警 示
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| The United Kingdom: Bromocriptine: monitor blood pressure when prescribing bromocriptine for prevention or inhibition of post-partum physiological lactation (English only) |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that 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.
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.
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 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.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-safety-update/bromocriptine-monitor-blood-pressure-when-prescribing-bromocriptine-for-prevention-or-inhibition-of-post-partum-physiological-lactation
In Hong Kong, there are 5 and 2 registered pharmaceutical products containing bromocriptine and cabergoline respectively. All products are prescription-only medicines. So far, the Department of Health (DH) has not received any adverse drug reaction with regard to bromocriptine and cabergoline.
Related news associated with the use of bromocriptine was previously issued by European Medicines Agency, Health Sciences Authority, Taiwan Food and Drug Administration and National Medical Products Administration, and was posted on the Drug Office website since 14 Jul 2014, with the latest update posted on 9 May 2019. Letters to inform local healthcare professionals were issued by the DH on 14 Jul 2014. In Feb 2015, the Registration Committee of the Pharmacy and Poisons Board discussed the matter and decided that the sales pack label and/or package insert of bromocriptine-containing products should include the relevant safety information. Safety information on blood pressure monitoring and should not be given to women with hypertension or pre-eclampsia has already been included in the package insert of Hong Kong registered cabergoline-containing products. The DH will remain vigilant on safety update of the drugs issued by other overseas drug regulatory authorities.
Ends/Friday, Oct 25, 2024
Issued at HKT 16:00
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