Menopause drug to be withdrawn in Europe

Veralipride is marketed under the trade names of Agreal or Agradil in Belgium,
France, Italy, Luxembourg and Portugal by Sanofi-Aventis. The EMEA’s Committee for Medicinal Products for Human Use (CHMP) concluded that the risks of veralipride in the treatment of hot flushes associated with the menopause in women are greater than its benefits and therefore recommended that the medicine should be taken off the market.

The committee recommended that treatment should not be stopped abruptly but the dose of veralipride should be reduced gradually. Side effects of the drug include depression, anxiety and tardive dyskinesia (a movement disorder which may be long-lasting or irreversible), both during and after treatment.

The recommendation was triggered by the withdrawal of veralipride from the Spanish market because of reports of serious side effects affecting the nervous system, and by a number of regulatory actions in other European Union Member States where veralipride is authorized.

The CHMP opinion will now be forwarded to the European Commission for the adoption of a decision.