Parker Waichman LLP

FDA Investigates Brain Infection in Patient Taking MS Drug

The U.S. Food and Drug Administration (FDA) is investigating a rare and serious brain infection developed by a patient taking the Novartis multiple sclerosis drug Gilenya (fingolimod). The patient, in Europe, developed progressive multifocal leukoencephalopathy (PML). The FDA said this was the first reported instance of the infection developing in a Gilenya patient who had […]

fda_investigation_brain_infectionThe U.S. Food and Drug Administration (FDA) is investigating a rare and serious brain infection developed by a patient taking the Novartis multiple sclerosis drug Gilenya (fingolimod).

The patient, in Europe, developed progressive multifocal leukoencephalopathy (PML). The FDA said this was the first reported instance of the infection developing in a Gilenya patient who had not previously received Biogen Idec’s drug Tysabri (natalizumab), Reuters reports. Tysabri, another multiple sclerosis (MS) drug, is associated with a high risk of PML and for this reason, demand for the drug has slowed. PML is potentially fatal.

Novartis informed the FDA of the infection in July but in an email to Reuters the company said the infection was unlikely attributable to Gilenya because the patient had a relatively short exposure to the drug (seven months); the patient had atypical MRI lesions before being treated with the drug; and the patient had repeated exposure to corticosteroids, which can contribute to the development of PML. The company said over 71,000 patients had been treated with Gilenya and “there has been no previous case of PML attributable to Gilenya.”

Gilenya was approved in the United States in September 2010 to treat relapsing forms of MS, a nervous system disease that affects the brain and spinal cord. Tysabri, approved by the FDA in 2004, was briefly withdrawn from market over concerns about PML, according to Reuters.  Because of its effectiveness as an MS treatment, it was reintroduced in 2006 with stricter safety warnings.

PML is caused by the JC (John Cunningham) virus, which is generally harmless, but can lead to an increased chance of PML in people with weakened immune systems.  Tysabri is an immune system-suppressing drug.

The FDA said patients taking Gilenya should not stop taking the drug without discussing this their health care provider.

 

 

What Our Clients Say About Us
We have worked with thousands of clients and we appreciate them and their positive reviews. Here are just a few recent client reviews...
5 Star Reviews 150
Great people great experience 5star
Renee Stumpf
3 years ago
5 Star Reviews 150
Excellent service from the best lawyers in New York Their customer service is excellent Especially Julie, Maryann, Dawn and the hardest the best JORGE Thank you very much to all
Jhony Gonzalez
6 months ago
5 Star Reviews 150
Positive: Professionalism , Quality , Responsiveness , Value
PENNY VALENCIA
3 years ago

Why Choose Us to Help You?

We Take Care of Everything
Your situation is stressful enough: Let us take on the deadlines, paperwork, investigation, and litigation. We'll handle every detail so you don't have to worry.
No Recovery = No Legal Fees
We work on a contingency-fee basis, meaning that we only get paid from a portion of your settlement or jury award. If you don't get compensation, you owe us nothing.
Decades of Experience
Your situation is stressful enough: Let us take on the deadlines, paperwork, investigation, and litigation. We'll handle every detail so you don't have to worry.
Respected by Our Peers
Judges, insurance adjusters, and fellow attorneys all speak highly of our skills, and we've earned numerous accolades, including a flawless rating from AVVO.
We Have Many Locations To Serve You
We have the experience and the skilled litigators to win your case. Contact us and speak with a real attorney who can help you.
Long Island – Nassau
Parker Waichman LLP
6 Harbor Park Drive
Port Washington, NY 11050
Long Island – Suffolk
Parker Waichman LLP
201 Old Country Road – Suite 145
Melville, NY 11747
New York
Parker Waichman LLP
59 Maiden Lane, 6th Floor
New York, NY 10038
Queens
Parker Waichman LLP
118-35 Queens Boulevard, Suite 400
Forest Hills, NY 11375
Brooklyn
Parker Waichman LLP
300 Cadman Plaza West
One Pierrepont Plaza, 12th Floor
Brooklyn, NY 11201
New Jersey
Parker Waichman LLP
80 Main Street, Suite 265
West Orange, NJ 07052
Florida
Parker Waichman LLP
27299 Riverview Center Boulevard
Suite 108
Bonita Springs, FL 34134
Nationwide Service
Parker Waichman LLP
59 Maiden Lane, 6th Floor
New York, NY 10038