Possible EU Restrictions on Bromocriptine for Inhibiting Lactation

Megan Brooks


July 11, 2014

The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has recommended restricted use of bromocriptine-containing medicines to inhibit lactation after childbirth, concluding that "rare but potentially serious (including fatal) cardiovascular, neurological and psychiatric side effects cannot be ruled out."

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, the PRAC says.

The committee also advises against using bromocriptine in women at increased risk for serious adverse effects, including women with disorders that increase blood pressure or severe psychiatric disorders.

The PRAC says bromocriptine-containing medicines should only be used for preventing or suppressing lactation (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 infant during or just after childbirth, or in mothers with HIV infection, who should not breast-feed.

The PRAC launched a review of bromocriptine-containing medicines for preventing or suppressing postpartum lactation in September 2013, as reported by Medscape Medical News.

The French medicines authority requested the review out of concern about rare but potentially fatal adverse events such as heart attack, stroke, hallucinations, manic episodes, and fits. The French regulator considered these risks unacceptable, given that "lactation is a natural process that eventually stops if the infant is not breastfed, and other means of management are available," the EMA says.

Based on its review, the PRAC said the available evidence confirms that bromocriptine is effective in preventing or suppressing lactation after childbirth but that an association between bromocriptine and events such as heart attack, stroke, fits, and psychiatric disorders cannot be ruled out.

The US Food and Drug Administration (FDA) withdrew bromocriptine's indication for lactation suppression in 1994 because of the risk for heart attack and stroke.

In the United States, a version of bromocriptine (Cycloset, VeroScience) is indicated for glycemic control in adults with type 2 diabetes. The FDA has approved another version (Parlodel, Novartis Pharmaceuticals) for Parkinson's disease, acromegaly, and problems related to hyperprolactinemia.

The PRAC recommendation will now be forwarded to the Coordination Group for Mutual Recognition and Decentralised Procedures–Human, which will adopt a final position.


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