Novartis’ MS treatment has warning label added

Novartis' MS treatment Gilenya has had warnings added to the label and prescribing information by the European Medicines Agency (EMA). These warnings flag up a possible risk of cancer and of a potentially fatal brain infection.

So far, three cases of progressive multifocal leukoencephalopathy (PML), the brain infection, have been reported in patients using the drug. In addition, 151 cases of basal cell carcinoma have been reported, the regulators say. It is thought that the risks stem from Gilenya’s ability to reduce immune system activity.

The EMA is also now issuing new recommendations for doctors and patients regarding the risks. Patients must be evaluated before and during Gilenya treatment in order to flag early signs of PML or skin cancer, and they should receive a baseline MRI scan and a medical skin evaluation before starting treatment.