We're unable to sign you in at this time. Please try again in a few minutes.
We were able to sign you in, but your subscription(s) could not be found. Please try again in a few minutes.
There may be a problem with your account. Please contact the AMA Service Center to resolve this issue.
Contact the AMA Service Center:
Telephone: 1 (800) 262-2350 or 1 (312) 670-7827  *   Email: subscriptions@jamanetwork.com
Error Message ......
Health Agencies Update |

FDA Notes Rare Infection in Patient Who Took Fingolimod for MS

Bridget M. Kuehn, MSJ
JAMA. 2013;310(16):1666. doi:10.1001/jama.2013.281116.
Text Size: A A A
Published online


The US Food and Drug Administration (FDA) is warning that a patient taking fingolimod for multiple sclerosis (MS) developed a rare and life-threatening brain infection.

Progressive multifocal leukoencephalopathy (PML) is a rare condition that leads to severe neurodegeneration and often death. It is caused by the John Cunningham (JC) virus, which is usually harmless but can trigger PML in immunosuppressed individuals.

Previously, the FDA and drug manufacturers have alerted the public to cases of PML among patients taking newer monoclonal antibody drugs, including efalizumab, mycophenolate mofetil, natalizumab, and rituximab, for autoimmune or inflammatory conditions (Kuehn BM. JAMA. 2009;301[14]:1423-1424). The labels of these immunosuppressing drugs have been updated to reflect this risk. But according to the FDA alert, the European patient with PML is the first case in a patient taking fingolimod who had not previously taken natalizumab, a drug also used to treat MS and Crohn disease. Because of its elevated risk of PML, natalizumab is available to US patients only through a restricted distribution program.

Sign in

Purchase Options

• Buy this article
• Subscribe to the journal
• Rent this article ?

First Page Preview

View Large
First page PDF preview




Also Meets CME requirements for:
Browse CME for all U.S. States
Accreditation Information
The American Medical Association is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. The AMA designates this journal-based CME activity for a maximum of 1 AMA PRA Category 1 CreditTM per course. Physicians should claim only the credit commensurate with the extent of their participation in the activity. Physicians who complete the CME course and score at least 80% correct on the quiz are eligible for AMA PRA Category 1 CreditTM.
Note: You must get at least of the answers correct to pass this quiz.
Please click the checkbox indicating that you have read the full article in order to submit your answers.
Your answers have been saved for later.
You have not filled in all the answers to complete this quiz
The following questions were not answered:
Sorry, you have unsuccessfully completed this CME quiz with a score of
The following questions were not answered correctly:
Commitment to Change (optional):
Indicate what change(s) you will implement in your practice, if any, based on this CME course.
Your quiz results:
The filled radio buttons indicate your responses. The preferred responses are highlighted
For CME Course: A Proposed Model for Initial Assessment and Management of Acute Heart Failure Syndromes
Indicate what changes(s) you will implement in your practice, if any, based on this CME course.


Some tools below are only available to our subscribers or users with an online account.

0 Citations

Sign in

Purchase Options

• Buy this article
• Subscribe to the journal
• Rent this article ?

Related Content

Customize your page view by dragging & repositioning the boxes below.

Articles Related By Topic
Related Collections
PubMed Articles