The French regulator ANSM has reassessed the risk/benefit profile of bromocriptine on behalf of the EMA. The active substance is indicated to inhibit lactation after delivery.
The assessment followed some reports of cardiovascular (cerebrovascular accident, myocardial infarction, and blood hypertension), neurologic (seizures), or psychiatric (hallucinations, mental confusion) undesirable effects. The product profile is still positive, provided that indications are restricted and contraindications, warnings, and precautions for use are reinforced. Therefore, bromocriptine should be used to inhibit lactation only in case of therapeutic need (intrauterine death, perinatal death, HIV-infected mothers, etc.). Moreover, the use of bromocriptine is contraindicated in patients with uncontrolled hypertension, pregnancy-related hypertension problems, hypertension occurring during delivery, coronary disease, serious cardiovascular problems, and symptoms of psychiatric conditions.
France assessing risk-benefit profile of bromocriptine
