Gilenya

Gilenya Lined to Deadly Brain Infections

Gilenya (Fingolimod) was approved in September 2010 as a treatment to reduce relapses and delay disability progression in patients diagnosed with relapsing forms of multiple sclerosis (MS). It was the first oral disease-modifying drug approved by the U.S. Food and Drug Administration (FDA) for such an indication.

Gilenya is also being investigated as a possible treatment for heart failure and arrhythmias.

Since its approval, Gilenya has been linked to a number of serious adverse events, including rare but fatal brain infections and multiple deaths.

Due to its short time on the market, healthcare providers have not identified all potential adverse events that could be associated with the drug. As a result multiple investigations have been initiated as experts work to better understand the potential side effects of the drug and the impact it may have on the human body.

ONGOING GILENYA INVESTIGATIONS

• Gilenya has been linked to a 46-percent increased risk of shingles and one shingle-related death.
• The drug has also been linked to a case of progressive multifocal leukoencephalopathy (PML) in Europe.
• The FDA has received at least 15 reports of encephalitis herpes and one encephalitis herpes-related death in connection with Gilenya.
• In 2011, the FDA began investigating the death of a patient who suddenly died within 24 hours of taking their first dose of Gilenya.

OTHER GILENYA SIDE EFFECTS

The FDA warns that treatment with Gilenya may also result in:

• Bradycardia
• Atrioventricular conduction
• Increased risk of infection
• Posterior reversible encephalopathy syndrome (PRES)
• Liver Injury
• Decrease in pulmonary function tests
• Changes in blood pressure.