english.prescrire.org > Topics > Advancing healthcare policy > Transparent, independent health authorities > Actions vis-à-vis regulatory agencies > Fingolimod (Gilenya°): EMA's lack of transparency spells danger for patients (2/2012)

Advancing healthcare policy

Transparent, independent health authorities

Transparent, independent health authorities: Actions vis-à-vis regulatory agencies
Fingolimod (Gilenya°): European Medicines Agency's lack of transparency spells danger for patients (February 2012)

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)

©Prescrire 20 February 2012