FDA: brain infection cases reported in patients taking Novartis’ Gilenya

Definite progressive multifocal leukoencephalopathy (PML) reported in individuals taking Gilenya (fingolimod) for multiple sclerosis

On August 4, 2015, the U.S. Food and Drug Administration issued a Drug Safety Communication warning that a rare brain infection was found among some patients taking the multiple sclerosis drug Gilenya. Gilenya is manufactured by Swiss pharmaceutical corporation Novartis AG. The risk of developing the brain infection, known as definite progressive multifocal leukoencephalopathy (PML), is being added to Gilenya’s warning label.

Gilenya is used to treat patients with relapsing forms of multiple sclerosis. This form of multiple sclerosis (MS) can cause attacks, when symptoms worsen. Gilenya is used to treat a patient’s immune system and reduce MS-related inflammation. PML is an extremely serious brain infection caused by the John Cunningham virus, which is a common and usually harmless virus but may cause PML and other diseases in patients with immunodeficiency.

PML symptoms include:

  • Clumsiness
  • Vision problems
  • Progressive weakness
  • Confusion
  • Increased trouble using legs and arms
  • Changes in thought patterns, personality, orientation, and memory

Novartis informed the FDA that one patient participating in the Gilenya post-market study had PML and that another patient probably had PML. In August 2013, the FDA previously stated it was investigating the case of a patient taking Gilenya who had PML, but did not link the MS drug with the brain infection.

Multiple Sclerosis Drug Lawsuit

The risk of PML has long been known to drug manufacturers. Prior to the Novartis Gilenya warning, sales of Biogen’s Tysabri and Tecfidera dipped after reports associated the drugs with progressive multifocal leukoencephalopathy.

If you or someone you love developed PML after taking a drug for multiple sclerosis, please call The Cochran Firm, D.C. Our dangerous drug attorneys are reviewing injury claims related to MS drugs and the unreasonable risks they may pose to consumers. Because strict time deadlines apply to filing a Gilenya injury claim, we recommend contacting us at your earliest convenience in order to preserve your rights.

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