EU to Study Risks of Bromocriptine for Inhibiting Lactation

Disclosures

September 06, 2013

European Union (EU) regulators announced today that they will study whether the cardiovascular, neurological, and psychiatric risks of using bromocriptine to inhibit lactation in women after childbirth outweigh the drug's benefits.

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

The European Medicines Agency (EMA) said the review of bromocriptine will not include examination of its use to treat other conditions such as hyperprolactinemia and Parkinson's disease. 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 French equivalent of the FDA asked the EMA to review bromocriptine because of concerns about rare but potentially fatal adverse events such as heart attack and stroke, hallucinations, manic episodes, and fits. French regulators deem these risks unacceptable given that "lactation is a natural process that eventually stops if the infant is not breastfed, and that other authorized products are available if there is a need to suppress it," the EMA stated.

The EMA noted that women may not breast-feed after giving birth for a variety of reasons, including stillbirth, HIV infection of the mother, and personal choice.

Bromocriptine, a dopamine receptor agonist, prevents the secretion of the hormone prolactin, which in turn suppresses milk production.

The EMA study of bromocriptine will be conducted by its Pharmacovigilance Risk Assessment Committee (PRAC). The recommendations of PRAC will go to another EU regulatory body called the Coordination Group for Mutual Recognition and Decentralized Procedures-Human (CMDh). CMDh represents individual EU member states, each of which approves drugs for marketing within its borders.

More information on today's EMA announcement is available on the agency's Web site.

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