Navigation Links
FDA Issues Public Health Advisory on Tysabri, a New Drug for MS

The Food and Drug Administration (FDA) today issued a public health advisory to inform patients and health care // providers about the suspended marketing of Tysabri (nataluzimab) while the agency and the manufacturer evaluate two serious adverse events reported with its use.

Tysabri, which received accelerated approval from FDA in November 2004, is an innovative treatment that represents a new approach to treating patients with relapsing forms of multiple sclerosis (MS).

"FDA worked with the company to make sure this information, even though preliminary, was given to physicians and patients as soon as possible and supports their decision to voluntarily suspend marketing as well as the use of the product in clinical trials. At the same time, FDA continues to believe Tysabri offers great hope to MS patients," said Dr. Steven Galson, Acting Director, FDA's Center for Drug Evaluation and Research (CDER). "Patients being treated with Tysabri should contact their physician to discuss appropriate alternative treatments while these reports are being evaluated," added Dr. Galson.

FDA received a report from Biogen Idec, the manufacturer of Tysabri, of one confirmed fatal case and one possible case of progressive multifocal leukoencephalopathy (PML) in patients receiving Tysabri for MS. FDA was given preliminary information about these cases by Biogen, Idec on February 18, 2005. Details became available to FDA the next week.

PML is a rare, serious progressive neurologic disease usually occurring in immunosuppressed patients. There is no known effective treatment for PML. Although the relationship between Tysabri and PML is not known at this time, because of the serious and often fatal nature of PML, FDA concurred with the company that the drug be voluntarily withdrawn from marketing and that the use of Tysabri in clinical trials be suspended until more is known.

During the review of Tysabri for marketing app roval, FDA conducted an intensive analysis of possible adverse events that might be related to effects of the drug on the immune system. No cases of PML were seen in the clinical trials. However, for any approved therapy, new and unexpected adverse events may occur that were not seen in clinical trials. In the case of Tysabri, required post-marketing studies facilitated the rapid reporting and response to this new information.

According to Biogen, Idec, outside of the approximately 3,000 patients who received the drug in clinical trials, approximately 5,000 additional patients with MS have received Tysabri through their primary physician. Because Tysabri was just recently approved, these patients have only received at most a few doses of Tysabri.

The FDA will maintain close contact with the company during the process of understanding the relationship between Tysabri and these two serious adverse events. The company is working on ways to get additional information soon about the possible risks of PML from the patients who have received Tysabri in the clinical trials.

The FDA urges health care providers and patients to report adverse event information to FDA via the MedWatch program by phone (1-800-FDA-1088), by fax (1-800-FDA-0178) or by the Internet at www.fda.gov/medwatch/index.html.
'"/>




Related medicine news :

1. Unsatisfactory Grade On Womens Health Issues
2. Who Board To Discuss Asian Tsunami Related Health Issues
3. WHO Issues Caution Against Bird Flu Epidemic
4. Sepsis Death Reported With Mifepristone – FDA Issues Warnin
5. High Court Issues Notice To Centre On Smoking Ban In Films
6. JRRD Focuses On Issues Such As Spinal Cord Injury and Prosthetics
7. China Issues New Legislation To Ban Human Organ Trade
8. Court Issues Order NACO On Gay Issue
9. NGOs and Various Groups Come Together To Address the Issues on AIDS
10. Budhias Medical Report Fails to Address Long Term Health Issues
11. HFEA Issues Warning On Risks Of Multiple Births With IVF
Post Your Comments:
*Name:
*Comment:
*Email:


(Date:3/24/2017)... ... ... who like to educate themselves on current issues and who enjoy gaining knowledge on ... to appreciate and love the "Informed" series, hosted by Rob Lowe. A new ... the world. , Running for charity has become a multi-million dollar enterprise ...
(Date:3/24/2017)... ... 24, 2017 , ... Empower Brokerage, located in Southlake, Texas, ... programs. , In February, 2017, Empower Brokerage introduced their new “Performance Partners” program ... to teach how to maximize their sales efforts, as well as how to ...
(Date:3/24/2017)... ... March 24, 2017 , ... “Finding Christ Through Social ... devotional journal chronicling the writer’s path toward true communion with God. “Finding Christ ... #TruthwithGrace” is the creation of published author Lea Michelle Johnson, a follower of ...
(Date:3/24/2017)... ... ... and Harvest A Cultivation of Christian Love” is the creation of published author, David ... wife, Anna Marie. He and his wife are the proud parents of four grown ... “Shadow and Substance.” , “Love, the agape kind, is seen as more than an ...
(Date:3/24/2017)... ... , ... “The Adventures of Joey, The Dog Who Barks at Puddles”: a ... to the fullest, as God intended. “The Adventures of Joey, The Dog Who Barks ... pursuing her passion for writing, especially about truth and human behavior. , Published by ...
Breaking Medicine News(10 mins):
(Date:3/24/2017)... , March 24, 2017 New England ... recipient of an award including funding and in-kind service ... draw technology.  "Making blood draws less ... making their whole hospital experience better.  We,re looking forward ... technology can help improve care for the kids we ...
(Date:3/24/2017)... YORK , March 24, 2017   ... leading organization within medical affairs in the pharmaceutical ... as the chair of a newly formed scientific ... board members to form the first ever medical ... For more information about the ACMA, please ...
(Date:3/24/2017)... Research and Markets has announced the addition ... - 2035" report to their offering. ... The Deep Learning: Drug Discovery and Diagnostics ... the growing market of deep learning solutions within the healthcare domain. ... emerged as a novel solution to generate relevant insights from medical ...
Breaking Medicine Technology: