The European Medicines Agency’s Committee on Medicines for Human Use is meeting in London this week and amongst other matters, the committee will be deliberating over the post marketing safety data for Acomplia. As we have announced in previous news items, the FDA in the US has not approved Acomplia for US consumers over concerns relating to adverse psychiatric events, including suicidal thoughts.
The post marketing data for European patients who have been treated with the medication include 208 adverse psychiatric events, including 27 of suicidal ideation. In total, over 100,000 patients across Europe have been prescribed this medication.
The committee began its meeting on Monday 16th July and it is expected to report on 19th July. Most analysts believe that Acomplia will not be withdrawn from the market in Europe but this still remains a possibility. The expected outcome is that there will be a recommendation to include a stronger warning about the possible side effects. Anyone with a history of major depression should not take this medication as the risk of adverse psychiatric events is higher amongst this population.