Drug safety alert: Risks of PML, basal-cell carcinoma, and opportunistic infections associated with Fingolimod (Gilenya▼)

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Fingolimod (Gilenya) is approved for treatment of relapsing-remitting multiple sclerosis in patients not responding to beta-interferon or those with severe and rapidly worsening of the disease.

Risk of PML
There have been reports of progressive multifocal leukoencephalopathy (PML) in patients receiving fingolimod, but none in the UK so far. PML is a rare, progressive, and demyelinating disease, often fatal caused by activation of the latent John Cunningham virus (JCV) in immunocompromised patients. Other multiple sclerosis drugs such as natalizumab (Tysabri) and dimethyl fumarate (Tecfidera) have also been linked to a risk of PML.

Risk of basal-cell carcinoma
There have been rep...