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
