Health Canada warning on Gilenya safety

Pharma regulatory agency Health Canada is informing Canadians that the drug label for the multiple sclerosis (MS) drug Gilenya (fingolimod) has been updated with new safety information on the risk of skin cancer, as well as a rare brain infection known as progressive multifocal leukoencephalopathy (PML).

Gilenya, marketed by Swiss pharma giant Novartis (NOVN: VX), is a prescription drug used in the treatment of relapsing-remitting multiple sclerosis to reduce the frequency of attacks (relapses) and delay the progression of physical disability. It is specifically used when other MS treatments have not been effective or cannot be tolerated.

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.