AIFA, in agreement with the European Medicines Agency and the Marketing Authorisation Holder, informs the Healthcare Professionals on the new recommendations for use of the medicinal product Mysimba, indicated for the management of weight adult patients with obesity or in the presence of weight-related comorbidities.

A review conducted at EU level confirmed that the data available so far was insufficient to fully determine the cardiovascular safety beyond 12 months, therefore treatment with Mysimba should be discontinued after one year if a patient has not maintained a loss of at least 5% of their initial body weight.

Physicians should conduct an annual assessment when considering treatment continuation, to ensure no adverse change in cardiovascular risk and maintenance of weight loss.