Other safety alerts
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| European Union: PRAC recommends restricted use of bromocriptine for stopping breast milk production |
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The European Medicines Agency has completed an EU-wide review of bromocriptine-containing medicines for preventing or suppressing lactation (breast milk production) in women after childbirth. The Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has recommended that the medicines only be used for this purpose (in strengths up to 2.5 mg) when there are compelling medical reasons for stopping lactation, such as 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, nor to relieve symptoms of pain or swelling of the breasts after childbirth. Such symptoms can be managed by measures such as breast support or applying ice, and the use of painkillers if needed.
The Committee also concluded that bromocriptine must not be used in women at increased risk of serious side effects, including women with disorders that increase blood pressure or severe psychiatric disorders. Blood pressure should be monitored so that early signs of problems can be detected and treatment stopped immediately.
The review of bromocriptine was carried out at the request of the French medicines authority (ANSM) following 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). ANSM considered that the risk of these events was not acceptable since lactation is a natural process that eventually stops if the infant is not breastfed, and other means of management are available.
The PRAC recommendation will now be forwarded to the Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) which will adopt a final position.
Please refer to the following website in EMA for details:
http://www.ema.europa.eu/../human_referral_prac_000031.jsp&mid=WC0b01ac05805c516
In Hong Kong, there are seven registered pharmaceutical products containing bromocriptine which are prescription-only medicines. So far, the Department of Health (DH) has not received any local adverse drug reaction report related to the drug. In view of the above announcement by the EMA, a letter to healthcare professionals will be issued to draw their attention to the issue and urge them to report any adverse drug reaction related to the drug. The DH will remain vigilant on any safety updates of the drugs and actions taken by overseas regulatory authorities and the final legally binding decision by the European Commission for further consideration.
Ends/ Monday, July 14, 2014
Issued at HKT 14:00
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