Last week, Novartis announced that a patient treated with the drugmaker’s multiple-sclerosis (MS) pill Gilenya was diagnosed with a rare and potentially fatal brain disease called progressive multifocal leukoencephalopathy (PML).
Prior to taking Gilenya, the patient was treated with another MS drug called Tysabri, which is co-marketed by Biogen Idec. Inc. and Elan Corp. At the time, Tysabri was already linked to PML.
"The current assessment is that Tysabri is the drug most likely associated with this case of PML," said Novartis. "However, a contribution of Gilenya to the evolution of this case can't be excluded."
This new case comes as health regulators throughout the world investigate the safety of the drug after reports of 11 patient deaths. Some patients also reported heart problems linked to Gilenya, according to the Wall Street Journal.
Other Gilenya side effects include macular edema or degeneration, swelling of the eyes, hemorrhage, blindness and infection.
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