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The Institute for Safe Medication Practices (ISMP) is urging the US Food and Drug Administration (FDA) to put restrictions on the use of fingolimod (Gilenya, Novartis) in patients with multiple sclerosis (MS), owing to postmarketing adverse event reports.

"Problems of widespread toxicity that were already evident in clinical testing of fingolimod are now producing strong signals in the postmarket adverse event data," the nonprofit group says in a new report.

The ISMP sifted through adverse event reports related to fingolimod that were reported via the FDA's MedWatch program in the second quarter of 2011.

"Notable" among them, they say, are 68 reports of serious infections, including eye, skin, urinary, and upper respiratory tract infections. Sixty eye-related side effects were also reported, including macular edema and vision disruptions.

In 14 cases, patients taking the drug experienced more generalised symptoms, including heart-rhythm problems and liver damage, the report states. Possible complications of these vascular adverse effects include syncope (16 cases), bradycardia (27 cases), and peripheral edema (10 cases), the report notes.

"The signals for fingolimod raise the question whether enough is known about the troubling safety profile of this drug to justify its continued unrestricted use. Its array of known adverse effects on the eyes, heart, liver, and immune response, as well as patient deaths in testing and postmarket surveillance, raise the question about its long-term use at the current approved dose," the ISMP concludes.

The report urges the FDA and manufacturer to "consider substantial restrictions on its use and enhanced monitoring" of patients using it.

Drug Currently Under Review

Fingolimod is the first oral agent for the treatment of MS. It was approved by the FDA in September 2010 and by the European Medicines Agency (EMA) in March 2011. However, the occurrence of the death of a patient soon after receiving a first dose of fingolimod in December 2011 has both the FDA and the EMA looking closely again at the risks and potential benefits of fingolimod. Those reviews are still under way.

Asked for reaction to the ISMP report, Timothy Coetzee, MD, Chief Research Officer of the National MS Society, told Medscape Medical News: "The FDA has already announced that it is reviewing the safety profile of Gilenya. We are following the matter closely and waiting to see the results of their investigation. Therefore, we feel that it would be somewhat premature to comment in advance of the release of the FDA findings, which we anticipate will be forthcoming soon."

The ISMP report is available online.

Source: Medscape Copyright © 1994-2012 by WebMD LLC (11/04/12)