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Fingolimod safety review launched over heart concerns

By News team

Multiple sclerosis drug fingolimod (Gilenya; Novartis) is being subjected to a safety review, launched by the European Medicines Agency following the unexplained death of a patient soon after starting treatment.

Heart problems have also been reported after the first dose of fingolimod, which came onto the UK market last year (April 2011) for the treatment of relapsing-remitting MS. The drug is offered to patients who have failed to respond to a beta-interferon or those whose disease is severe and rapidly worsening.

Monitoring of patients after they receive their first dose should be increased pending the outcomes of the review, which is expected to be completed by March 2012, the EMA’s Committee for Medicinal Products for Human Use has advised. Patients should undergo an electrocardiogram before treatment starts and continuously for the first six hours after receiving their first dose. Blood pressure and heart rate should also be checked hourly for the first six hours of treatment, the CHMP says.

Patients are advised to contact their GP if they experience any symptoms that suggest heart problems — such as chest pain, weakness or dizziness — and to speak to a pharmacist or doctor if they have any queries about the safety of the drug.

Novartis has promised to supply the CHMP with findings from its ongoing investigations into the cardiovascular effects of fingolimod.

Bradycardia was already known to be a common adverse event at the start of fingolimod treatment, and product information advises that patients be observed for signs and symptoms of bradycardia for at least six hours after the first dose.

Citation: The Pharmaceutical Journal URI: 11093535

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  • Fingolimod (Gilenya; Novartis) pack shot

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