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Canadian Health Regulatory Agency Issues New Safety Information for Multiple Sclerosis Drug Gilenya

Oct 1, 2015

Health Canada, the Canadian health regulatory agency, has updated the drug label for the multiple sclerosis drug Gilenya (fingolimod) to include new safety information on the risk of skin cancer, as well as a rare brain infection known as progressive multifocal leukoencephalopathy (PML), which can be fatal.

Gilenya is a prescription drug used in the treatment of relapsing-remitting multiple sclerosis (MS) to reduce the frequency of attacks (relapses) and delay the progression of physical disability, Health Canada explains. Gilenya is used specifically when other MS treatments have not been effective or cannot be tolerated.

Gilenya works by modifying the immune system and reducing the access of certain immune cells (white blood cells known as lymphocytes) to the brain and spinal cord, which may reduce the damage that occurs in these areas in MS and the frequency of MS relapses. A Health Canada safety review found that Gilenya, like other drugs that suppress the immune system, may increase the risk of lymphomas and other cancers, particularly skin cancers.

Medicines that suppress the immune system also reduce the body's ability to fight infections. Cases of PML, a rare infection caused by the John Cunningham (JC) virus, have been reported in Gilenya users—including in patients who were not currently taking and had not previously taken other medications that suppress or change the immune system. The JC virus is a common virus and is harmless in most people but can cause PML in some patients with weakened immune systems. In severe cases, it can lead to disability or death.

Gilenya labeling already contained information on the possible risk of lymphoma, and warnings about how the drug reduces the body's ability to fight infection. Health Canada updated label information to include the risk of skin cancer and PML specifically, and to advise patients and health care professionals to be alert to symptoms.

Changes in the size, shape or color of moles, or open sores that do not heal may be signs of skin cancer. Anyone taking Gilenya who experiences such signs should talk to a doctor. Basal cell carcinoma (BCC), a common skin cancer, is the type most often reported by Gilenya users. Patients who experience worsening MS symptoms should speak to a doctor. New or worsening weakness, trouble using the arms or legs, or changes in thinking, memory, eyesight or balance could indicate that the person is developing PML.

Health Canada says patients taking Gilenya should not use other medications that suppress or change how the immune system works at the same time as using Gilenya because this can increase the risk of infection and PML. If PML is suspected, Health Canada advises the physician to suspend Gilenya treatment until PML has been ruled out.

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