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Serious Brain Infection Reported In Gilenya Patient

Apr 16, 2012 | Parker Waichman LLP

We’ve been following serious side effects linked to patients taking multiple sclerosis (MS) medication Gilenya (gingolimod). Now, a serious brain infection has been reported in a Gilenya patient. Gilenya was approved for the treatment of relapsing-remitting MS and is used to reduce the frequency of flare-ups and delay physical disability.

The patient, who was taking the Novartis AG drug, developed a potentially deadly infection of the brain, said Bloomberg Businessweek. The patient also received a Tysabri injection, which is manufactured by Biogen Idec Inc. and Elan Corp., prior to taking Gilenya, according to an email Novartis sent Businessweek. Tysabri increases viral infections known as progressive multifocal leukoencephalopathy, which can lead to death or severe disability, according to a warning Tysabri’s label.

Although Novartis argued that Tysabri is the likely culprit, it said that “a contribution of Gilenya to the evolution of this case cannot be excluded.”

This is the first case of this type of infection in Gilenya users since it was approved in 2010; 36,000 patients have been treated with the drug since its approval. Meanwhile, we recently wrote that Gilenya is under review by regulators in the U.S. and Europe. According to Businessweek, the U.S. Food & Drug Administration (FDA) and the European Medicines Agency (EMA) are reviewing the deaths of 11 Gilenya patients, said Businessweek. The EMA is expected to release its results by April 20.

The FDA review was announced last December after a patient died within 24 hours of taking his/her first dose of Gilenya. EMA regulators started their review in February after receiving reports of 10 additional deaths among Gilenya patients. According to Novartis AG, six deaths were unexplained, three resulted from heart attacks, and one was due to disruption of heart rhythm.

Most recently, the Institute for Safe Medication Practices (ISMP) called for the FDA to restrict use of Gilenya and improve its patient monitoring following a review of adverse events reported to the FDA in the second quarter of last year. “Problems of widespread toxicity that were already evident in clinical testing of (Gilenya) are now producing strong signals in the post-market adverse event data,” ISMP.

Of 286 reports, 60 involved retinal injuries and other adverse vision effects; 68 involved infection reports at various areas of the body, eye, skin, urinary tract, and upper respiratory tracts; and a number of vascular-related adverse effects including 16 blackouts or syncope, 27 reductions in blood pressure, slow heart rate, or bradycardia, and 10 cases of peripheral edema, said Pharmalot.

ISMP, while acknowledging Gilenya’s advantages, noted that clinical testing conducted prior to FDA approval “revealed a troubling safety profile that might have halted the development of drugs for many other disorders with a less serious long-term prognosis,” said Pharmalot previously. ISMP also discussed a decision made by Novartis to discontinue a 1.25 mg dose over very serious adverse events, including two deaths from opportunistic herpes infections, a rare and fatal MS deterioration, and six vascular events: The clinical trial arm focused on the 1.25 mg dose was terminated for safety reasons; Novartis only sought approval of a 0.5 mg dose.

Meanwhile data provided to the FDA revealed a number of serious side effects—birth defects in typical animal screening studies; herpes infections; lower respiratory tract infections, as well as unusual ear, sinus, and eye infections; and two deaths—yet agreed to fast track Gilenya’s approval schedule

Of note, eight percent of patients prescribed the recommended dose of Gilenya tested with evidence of liver damage, although routine liver testing is not recommended. And, trials before approval included three cancer deaths in which the FDA was not able to rule out Gilenya as a potential culprit.

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