Saturday, 3 March 2012

EMA under fire for refusing to supply details on fingolimod

Agency is under fire for refusing to supply details of sudden deaths after first dose of multiple sclerosis drug. BMJ 2012; 344 doi: 10.1136/bmj.e1360 (Published 23 February 2012)

"The European Medicines Agency has been criticised for refusing to supply the French independent drug bulletin, Prescrire, with data on cases of sudden death after the first dose of the multiple sclerosis drug fingolimod.

Fingolimod was authorised by the European Medicines Agency in March 2011 for the treatment of relapsing remitting multiple sclerosis in patients whose disease has failed to respond to a β interferon or is severe and getting worse rapidly.

On 20 December 2011 the US Food and Drug Administration reported that a patient with multiple sclerosis had died within 24 hours of taking the first dose of fingolimod, marketed by Novartis. The patient was also taking a β blocker and a calcium channel blocker.

On 22 December Prescrire contacted the European Medicines Agency to ask for a review of the serious adverse effects of fingolimod and for the initial European Periodic Safety Update Report, which must be filed with the agency within six months …"




"This is not good; what we need is transparency."



CoI: multiple

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