FDA Alert: Multiple Sclerosis Drug May Cause Serious Brain Infection

Article

The Food and Drug Administration (FDA) has issued a warning regarding a serious side effect associated with a drug used to treat multiple sclerosis (MS).

The Food and Drug Administration (FDA) has issued a warning regarding a serious side effect associated with a drug used to treat multiple sclerosis (MS).

Gilenya (fingolimod), an immunomodulator used for relapsing forms of MS, is the culprit behind one definite and one probable case of progressive multifocal leukoencephalopathy (PML). The rare but serious brain infection is caused by the John Cunningham (JC) virus.

“These are the first cases of PML reported in patients taking Gilenya who had not been previously treated with an immunosuppressant drug for MS or any other medical condition,” the statement said.

While the JC virus is harmless in most people, it can lead to PML in those with compromised immune systems. In August 2013, there was a suspected case of the infection due to Gilenya. However, the patient had been taking an immunosuppressant that could cause PML and was also going through several courses of intravenous corticosteroids, which can weaken the immune system, at the same time. Therefore, a definite conclusion was not possible.

If healthcare professionals suspect PML, a diagnostic evaluation should performed.

The FDA advises that patients should continue taking Gilenya unless otherwise specified by their doctor but should seek medical attention right away if they experience:

  • New or worsening weakness
  • Increased trouble using their arms or legs
  • Changes in thinking, eyesight, strength or balance

New warnings signaling the PML cases will be added to the drug’s label.

Related Videos
How to Adequately Screen for and Treat Cognitive Decline in Primary Care
Tailoring Chest Pain Diagnostics to Patients, with Kyle Fortman, PA-C, MBA
James R. Kilgore, DMSc, PhD, PA-C: Cognitive Decline Diagnostics
Solutions to Prevent Climate Change-Related Illness, with Janelle Bludhorn, PA-C
Kyle Fortman, PA-C, MBA: Troponin and Heart Injury Risk Screening Recommendations
What Should the American Academy of Physician Associates Focus on in 2025?
The Rising Rate of Heat-Related Illness, with Janelle Bludhorn, PA-C
Stephanie Nahas, MD, MSEd | Credit: Jefferson Health
Mikkael Sekeres, MD:
© 2024 MJH Life Sciences

All rights reserved.