Health Canada Warns of Skin Cancer, Brain Infection Risk with Gilenya

Health Canada has updated the warning label on Gilenya to warn about the risk of skin cancer and a rare brain infection known as progressive multifocal leukoencephalopathy (PML). Gilenya is used to treat relapsing-remitting multiple sclerosis. Gilenya is used when other treatments do not work or cannot be used by a patient.

According to Health Canada’s safety announcement, a review by the regulatory agency showed that Gilenya, like other immunosuppressants, can increase the risk of lymphomas and other cancers, especially of the skin. Multiple sclerosis is an autoimmune disease where the body’s own immune system attacks the protective myelin sheath surroounding the brain and spinal cord. Gilenya tries to combat the effects of MS by suppressing the immune system and preventing certain immune cells from reaching the brain and spinal cord.

“Gilenya labelling already contained information on the possible risk of lymphoma, and warnings about how this drug reduces the body’s ability to fight infection. It has been updated to include the risk of skin cancer and PML specifically, and to advise that patients and health professionals be vigilant for symptoms.” the notification read.

Drugs that suppress the immune system also impair the ability to ward off infection. Health Canada states that cases of a rare brain infection called PML have been reported in Gilenya users. These cases include patients who were not taking other immunosuppressants. PML is caused by the John Cunningham (JC) virus. In most people, the JC virus is harmless; those with a compromised immune system, however, may develop PML.

Health Canada advises patients to monitor any existing moles for changes in size, shape or color as this may be an indication of skin cancer. Patients should also observe any existing open sores and see a doctor if they don’t health within weeks of starting treatment. The most common form of skin cancer reported with Gilenya use is basal cell carcinoma (BCC). The agency recommends that users see their doctors if they notice symptoms, “including any skin nodules (e.g. shiny pearly nodules), patches or open sores that do not heal within weeks”.

from Parker Waichman http://www.yourlawyer.com/blog/health-canada-warns-of-skin-cancer-brain-infection-risk-with-gilenya/