english.prescrire.org > Topics > Advancing healthcare policy > Fingolimod (Gilenya°): EMA's lack of transparency spells danger for patients (2/2012)

Advancing healthcare policy

Via its policy advocacy, Prescrire acts as a force for change in health policies, first and foremost in the interest of patients.

Advancing healthcare policy

Fingolimod (Gilenya°): European Medicines Agency's lack of transparency spells danger for patients (February 2012)

The European Medicines Agency (EMA) has refused to supply Prescrire with the detailed data in its possession on cases of death which occurred following the first dose of fingolimod (Gilenya°). This lack of transparency spells danger for patients. Read on...

Summary

Fingolimod (Gilenya°) is an immunosuppressant authorised since March 2011 by the European Medicines Agency (EMA) for certain patients with multiple sclerosis.
In December 2011, the US Food and Drug Administration (FDA) reported the sudden death of a patient within the first 24 hours of taking fingolimod. On 22 December 2011 Prescrire asked EMA for a review of the serious adverse effects of fingolimod.
On 23 January 2012 EMA informed Prescrire that its request for information dated 22 December was rejected, on the grounds that a European re-evaluation of fingolimod was under way: the re-evaluation had been initiated 3 days earlier.
On 7 February 2012, Prescrire reiterated its information request, this time to EMA Director Guido Rasi. As of 17 February 2012, EMA's Director has not replied to Prescrire.
Once again the European Agency is refusing to provide patients and healthcare professionals with important information on adverse effects.
It is high time that they get back to their primary mission: protecting patients’ health, which should take precedence over protecting the financial interests of pharmaceutical companies.

For more information:

> Fingolimod (Gilenya°): European Medicines Agency’s lack of transparency spells danger for patients (February 2012)