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Group Calls for Significant Gilenya Restrictions

Apr 6, 2012

A patient safety group believes access to the multiple sclerosis drug Gilenya should be severely restricted because its short time on the market has been plagued by reports of fatal adverse reactions.

According to a report at, the Institute for Safe Medicine Practices’ call for the Food and Drug Administration to limit the use of Gilenya is based mostly on its association with more than a dozen deaths and an overwhelming number of adverse reaction reports during its first few months on the worldwide market.

Gilenya was approved last year as a new treatment for multiple sclerosis (MS). It is the first pill-form drug used in the treatment of the debilitating and often fatal disease.

During the second quarter, the Food and Drug Administration received 286 adverse reaction reports from Gilenya patients, including 60 cases of “retinal injuries” and other eye conditions. The drug was also associated with at least 68 cases of severe infections, especially of the eyes, skin, urinary tract, and upper respiratory tract. Cases of blackouts, reduced blood pressure, bradycardia (slow heart rate), and peripheral edema were also common among those adverse reaction reports.

In addition to those reports, the FDA is also investigating the death of a patient taking Gilenya after its maker, Novartis, announced it was looking into that report. Shortly after that announcement last year, the European Medicines Agency said it had received another 11 reports of deaths possibly attributed to an MS patient taking Gilenya.

The watchdog group fears Gilenya will always pose these risks to MS patients and that only close monitoring of a select group of patients will help reduce the frequency of these adverse reaction reports. ISMP said the drug demonstrated an association to these similar side effects during pre-market clinical trials but was likely approved by the FDA because it was a first-of-its-kind treatment.

Further adding to the group’s worries is the move by Novartis shortly after it was on the market to stop selling the highest dose, 1.25 mg, of Gilenya because the drug at that strength had been linked to an “opportunistic” herpes infection, a life-threatening “MS deterioration” and other maladies.

The group is concerned with the rush to get Gilenya approved, noting that it was rushed through the agency’s fast-track approval system despite the pre-market testing showing it could cause widespread problems for patients.

A senior scientist with ISMP told the news source for the report, “The unfolding safety profile of Gilenya shows that getting faster access to innovative new drugs can also involve substantial risks to the public. The fact is a powerful new drug might help you and it might harm you, and only time-consuming testing separates the help from the harm.”

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