Global Drugs & Biologics Update

Europe

ANSM - Agence Nationale de Sécurité du Médicament

Risk/benefit of bromocriptine for suppression of lactation re-evaluated

Bromocriptine-based drugs indicated in the inhibition of lactation were the subject of a European risk/benefit reassessment at the initiative of ANSM. This re-evaluation is in response to reports of adverse cardiovascular, neurological and psychiatric effects reported in connection with this indication. ANSM has concluded after considering all of the available data that the risk / benefit of these drugs remains favorable, subject to contraindications and recommendations for safe use.