The European Medicines Agency yesterday recommended products containing veralipride be taken off the market after its scientific advisory panel, the Committee for Medicinal Products for Human Use, concluded that its risks in treating menopausal hot flushes are greater than its benefits. Veralipride is sold by sanofi-aventis as Agradil and Agreal in Belgium, France, Italy, Luxembourg and Portugal.
Veralipride is a neuroleptic that works by blocking the activity of the neurotransmitter dopamine. While veralipride does show “limited efficacy”, notes the CHMP, it is also associated with side effects, including depression, anxiety and the potentially long-term movement disorder tardive dyskinesia both during and after treatment.
The EMEA cautions that the dose should be reduced gradually and says patients should consult with their doctor to be moved onto other therapies.
The assessment took place after a request by the European Commission in September last year, following the products’ withdrawal in Spain on reports of nervous system side effects in June 2005. There have also been regulatory actions in other European Union member states, including strengthening the products’ labeling, but these have clearly not been satisfactory in stemming the problems associated with veralipride.