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time, because of the serious and often fatal nature of PML, FDA concurred with the company that the drug be voluntarily withdrawn from marketing and that the use of Tysabri in clinical trials be suspended until more is known.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:6/26/2016)... ... June 27, 2016 , ... Quality metrics are proliferating in cancer care, and ... in the eye of the beholder, according to experts who offered insights and commentary ... of Managed Care. For the full issue, click here . , For the ...
(Date:6/26/2016)... ... June 26, 2016 , ... Many women are ... with endometriosis. These women need a treatment plan to not only alleviate symptoms ... can help for preservation of fertility and ultimately achieving a pregnancy. The specialists ...
(Date:6/25/2016)... ... June 25, 2016 , ... First Choice Emergency Room , the largest ... as the Medical Director of its new Mesquite-Samuell Farm facility. , “We are ... Mesquite location,” said Dr. James M. Muzzarelli, Executive Medical Director of First Choice Emergency ...
(Date:6/24/2016)... ... June 24, 2016 , ... A recent article published ... unfamiliar with. The article goes on to state that individuals are now more comfortable ... less common operations such as calf and cheek reduction. The Los Angeles area medical ...
(Date:6/24/2016)... ... June 24, 2016 , ... Global law firm Greenberg Traurig, P.A. announced that ... chosen by their peers for this recognition are considered among the top 2 percent ... special honors as members of this year’s Legal Elite Hall of Fame: Miami ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)... 24, 2016  Arkis BioSciences, a leading innovator ... more durable cerebrospinal fluid treatments, today announced it ... funding is led by Innova Memphis, followed by ... private investors.  Arkis, new financing will accelerate the ... market release of its in-licensed Endexo® technology. ...
(Date:6/23/2016)... DUBLIN , June 23, 2016 ... "Dialysis Devices Global Market - Forecast to 2022" report ... is the treatment method for the patients with kidney failure, ... and excess fluid from the patient,s blood and thus the ... sodium, potassium and chloride in balance. Increasing ...
(Date:6/23/2016)... 23, 2016 Research and Markets ... Market by Type (Organic Chemical (Sugar, Petrochemical, Glycerin), Inorganic ... Coating, Parenteral) - Global Forecast to 2021" report ... The global pharmaceutical excipients market is projected to ... of 6.1% in the forecast period 2016 to 2021. ...
Breaking Medicine Technology: