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Gilenya Side Effects Warrant Restrictions, ISMP Says

Filed April 6th, 2012 Laurie

The Institute for Safe Medicine Practices is urging the Food and Drug Administration to place heavy restrictions on the use of the drug Gilenya and enhance patient monitoring after drug maker Novartis began investigating a death tied to the pill, followed by the FDA, and eventually the European Medicines Agency.

The Institute issued their recommendation after reviewing a batch of adverse events that were reported to the FDA during the second quarter of 2011. The FDA received 60 reports of retinal injuries and other adverse events related to vision. The agency received 68 reports of infections at various sites including the eye, skin, urinary and upper respiratory tracts. Patients also reported vascular adverse effects: 16 cases of blackouts or syncope, 27 cases of reduced blood pressure, slow heart rate or bradycardia, and 10 cases of peripheral edema.

Gilenya is the first pill made for the treatment of Multiple Sclerosis. The Institute said clinical testing prior to the approval of the drug “revealed a troubling safety profile that might have halted the development of drugs for many other disorders with a less serious long-term prognosis.” Even so, the FDA agrees to “fast-track” the schedule for approval of Gilenya. ISMP believes the agency may have approved an unnecessarily high dose of the drug.

Novartis said it still believes Gilenya provides a benefit for patients living with relapsing remitted multiple sclerosis and will work to ensure patients still have access to the drug.

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