Parker Waichman LLP

FDA Announces Tysabri Label Update

Last week, the U.S. Food & Drug Administration (FDA) announced it was updating the label of Tysabri (natalizumab) to include additional information about the risk of progressive multifocal leukoencephalopathy (PML), a rare but serious brain infection. According to a Drug Safety Communication issued by the FDA, the Tysabri label will also now include safety information […]

Last week, the U.S. Food & Drug Administration (FDA) announced it was updating the label of <"https://www.yourlawyer.com/topics/overview/tysabri">Tysabri (natalizumab) to include additional information about the risk of progressive multifocal leukoencephalopathy (PML), a rare but serious brain infection. According to a Drug Safety Communication issued by the FDA, the Tysabri label will also now include safety information about patients who have taken other drugs that suppress the immune system, who may be at a higher risk for PML.

Tysabri, marketed by Biogen Idec Inc. and Elan Corp., is approved for the treatment of multiple sclerosis (MS) and Crohn’s disease. PML attacks the brain and central nervous system and is usually fatal. Symptoms include vision problems, loss of coordination, and memory loss. Patients who survive the disease are often permanently disabled. Because of the PML risk, Tysabri was actually removed from the market briefly in 2005, after three patients in a Tysabri clinical trial developed the disease.

Though considered one of the most effective multiple sclerosis treatments available, Tysabri is generally only used in people who have not responded to other treatments. Because of its association with PML, Tysabri is now available to patients only through a restricted distribution program called the Tysabri Outreach Unified Commitment to Health (the TOUCH Prescribing Program).

As we’ve reported in the past, Biogen Idec and Elan provide monthly updates on the number of PML cases associated with Tysabri. As of early March, 102 cases of the infection were confirmed in Tysabri patients, including 21 deaths.

According to the FDA’s Drug Safety Communication, the revised Tysabri drug label includes:

• A table summarizing rates of PML with Tysabri use according to the number of infusions (how long the drug is taken or duration of exposure).

• Information on a newly identified PML risk factor. Patients who took an immune system suppressing medication (e.g., mitoxantrone, azathioprine, methotrexate, cyclophosphamide, mycophenolate) prior to taking Tysabri have been shown to be at an increased risk for developing PML. The Tysabri label already warned that using immune system suppressing medications at the same time as Tysabri may increase the risk of developing PML.

Data from the past year have confirmed that the risk of developing PML is greater in patients who have received more than 24 Tysabri infusions (corresponding to two years of continuous treatment) compared to patients who have received fewer than 24 infusions, the FDA said in its Drug Safety Communication.

The FDA said it anticipates that the new PML information in the Tysabri label will aid healthcare professionals in assessing the risk for PML and in discussing that risk with their patients.

The FDA continues to advise patients to discuss any questions or concerns about Tysabri and the risk of PML with their healthcare professional. Patients should report any Tysabri side effects they experience to their healthcare professional.

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
Working with Nicole Copertino made them process so easy, As a retire Police officer and veteran she very professional and at the same time made me feel human not just broke client or a “PAY DAY” for her. Keep up the excellent work
Jerry Joly
10 months ago
5 Star Reviews 150
You guys are the best lawyer institutions i have ever know thank you for helping me so much with my case ❤️
estarlin torres
9 months ago
5 Star Reviews 150
I thank you all for your concern and great service to me leading to a final decision and compensation. Everything worked out for the best with your professional help and service. Gina Viti was the best! Thank you again!
Richard P LoPresti
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