ISMP Recommends Safety Guidelines for Gilenya

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Health regulators throughout the world are reviewing the safety of a new immunosuppressant drug for multiple sclerosis (MS) after reports of 11 patient deaths occurring immediately after starting the drug, as well as for other issues.

In addition to the reports of these 11 deaths, the Institute for Safe Medicine Practices found signals in the adverse events reported to the Food and Drug Administration (FDA) in the second quarter of 2011 that reinforce and expand safety concerns. It identified 286 incidents of reported serious adverse side effects for Gilenya (fingolimod), including six patients who died, and eight left permanently disabled. Sixty-eight cases involved infections, including one patient death from a herpes infection. An additional 60 cases involved adverse reactions in the eyes, such as swelling, macular edema or degeneration, hemorrhage, blindness and infection.

The ISMP suggests that the FDA and the drug’s manufacturer consider imposing restrictions on Gilenya’s use and enhance monitoring of patients on the drug.

The FDA approved Gilenya in 2010 and the drug was cleared for use in Europe in March 2011. It is the first oral treatment for MS, a debilitating neurological disorder.

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