The Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) has recommended the restricted use of bromocriptine to prevent or suppress breast milk production (lactation) after childbirth.

Bromocriptine is a dopamine receptor agonist that mimics some of the actions of dopamine, a hormone that regulates the release of another hormone, prolactin, which in turn controls lactation.

"The CMDh said that bromocriptine-containing medicines should only be used in the event of compelling medical reasons."

The CMDh said that bromocriptine-containing medicines should only be used in the event of compelling medical reasons such as a need to avoid further distress after the loss of a baby during or just after childbirth, or in mothers with HIV infection, who should not breastfeed.

Bromocriptine must be avoided by women who have increased risks of serious side effects, including those with various disorders that increase blood pressure or who have had heart disease or severe psychiatric disorders.

The CMDh recommendation is in line with EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) review, which provided data on the safety and effectiveness of bromocriptine in controlling breast milk production after childbirth.

The CMDh’s position was adopted by a majority vote, which will be forwarded to the European Commission, in a bid to take an EU-wide legally binding decision.

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In many EU countries, bromocriptine-containing medicines have been licensed for use to prevent or stop milk production after childbirth in women who are not breastfeeding.

Bromocriptine should only be used orally in strengths up to 2.5mg to inhibit lactation, and products with strengths of 5mg or 10mg are not indicated for such use, according to the CMDh.

In addition, the drug can be used to treat other conditions such as hyperprolactinaemia or high levels of prolactin in the body, as well as Parkinson’s disease.