June 27, 2014

Possible Safety Issue Being Investigated with Novartis Pill Gilenya

Our sympathies go out to the family of an American who recently died within 24 hours of receiving a first dose of the oral medication Gilenya® (fingolimod, Novartis). Novartis has confirmed this event and has reported it to the Health Authority around the world including Health Canada. Details of this unfortunate incident have not been released and are under investigation. Until more information is available about the circumstances of this individual’s death, it is impossible to know what role Gilenya may have played in it.

According to company reports, more than 28,000 patients have received this new oral therapy to date. This event is being reported in various media outlets.

On November 16, 2011, the Canadian Agency for Drugs and Technologies in Health announced the Common Drug Review (CDR) recommendation that fingolimod (Gilenya), the first oral disease modifying therapy, be reimbursed through provincial and territorial public drug programs. Health Canada approved Gilenya in March 2011. Gilenya is indicated as monotherapy for the treatment of patients with the relapsing-remitting form of MS to reduce the frequency of clinical exacerbations and to the delay the progression of physical disability. Gilenya is generally recommended in MS patients who have had an inadequate response to, or are unable to tolerate, one or more therapies in MS.

Individuals who have questions about Gilenya’s safety should contact the Novartis patient support line at Novartis Pharmaceuticals Canada Inc.
(1-855-745-5467) or the individual’s prescribing doctor.

Please see the below link for the Gilenya announcement in March