Drugs Xagena
The EMEA ( European Medicines Agency ) has recommended the withdrawal of the marketing authorisation for medicinal products containing Veralipride.
The EMEAs 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.
Patients who are taking medicinal products containing Veralipride for the treatment of hot flushes
should consult their doctor to discuss other treatment options if necessary.
Treatment should not be stopped abruptly but the dose of Veralipride should be reduced gradually.
Following the assessment of all available information on the safety and efficacy of Veralipride, the
CHMP concluded that, while Veralipride shows limited efficacy, it is associated with side effects,
including depression, anxiety and tardive dyskinesia, both during and after treatment.
This assessment was carried out, following a request from the European Commission in September 2006.
This 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 authorised.
Source: EMEA, 2007
XagenaMedicine_2007
