english.prescrire.org > Spotlight > 100 most recent > Fingolimod (Gilenya°): European Medicines Agency's lack of transparency spells danger for patients


Every month, the subjects in Prescrire’s Spotlight.

100 most recent :  1 | 10 | 20 | 30 | 40 | 50 | 60 | 70 | 80 | 90

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

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.

Fingolimod (Gilenya°) is an immunosuppressant which has been authorised since March 2011 by the European Medicines Agency (EMA) for certain patients with multiple sclerosis. The pre-marketing evaluation data already revealed cardiac arrhythmia, among other disorders. In April 2011 Prescrire recommended limiting use of fingolimod to rigorously supervised clinical trials.

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, in response to the FDA alert and faced with EMA’s silence, Prescrire asked EMA for a review of the serious adverse effects of  fingolimod, and for the initial European Periodic Safety Update Report (PSUR), which must be filed with EMA within 6 months of the marketing authorisation, i.e. in September 2011.

It was not until 20 January 2012 that the European Agency issued a public announcement on the subject, stating that there had been 3 other sudden deaths and 3 unexplained deaths. Three days later, on 23 January 2012, just 34 minutes before the legally mandated deadline, 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, vigorously contesting EMA’s grounds for refusal. 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 after the drug has come onto the market, information that is itself the fruit of the reporting work carried out by patients and healthcare professionals.

In May 2011, EMA had already invoked a re-evaluation under way to justify its refusal to provide Prescrire with information on pioglitazone (Actos°), which increases the frequency of bladder cancer and is no longer reimbursed by France’s national health insurance system. The European Commission has maintained the marketing authorisation for pioglitazone.

In early 2012, the European Medicines Agency and the European Commission’s Directorate General for Health and Consumers are behaving just as they did before the Mediator° fiasco. They give the benefit of the doubt to drug companies rather than to patients, and dispense information about adverse effects only sparingly. 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.

©Prescrire 20 February 2012

For more information:

Pioglitazone (Actos°): the
European Medicines Agency (EMA)
fails yet  again to be transparent
(July 2011)

Transparency of European
drug regulatory authorities:
improvements needed
(Online dossier)

Prescrire maintains all 5 complaints
filed with the European Ombudsman,
following the response by the
European Medicines Agency (EMA)
(April 2011)

See also:

Legal obligations for transparency
at the European Medicines Agency:
Prescrire’s assessment over four years
Prescrire International 2009 ;
18 (103) : 228-233.
Pdf, free