Navigation Links
More Doses of MS Drug Raise Risk of Brain Infection
Date:2/5/2010

FDA adds new warning on Tysabri label, but says benefits still outweigh dangers

FRIDAY, Feb. 5 (HealthDay News) -- In the latest blow to the controversial multiple sclerosis drug Tysabri, the U.S. Food and Drug Administration on Friday announced that it was slapping a new warning on the drug's label.

In an advisory sent to health-care professionals and patients, the FDA warned that the risk of developing progressive multifocal leukoencephalopathy (PML), a rare but deadly brain infection, increases as more infusions are received.

"This is updated information, taking new cases into account," explained Dr. William Sheremata, professor emeritus of neurology at the University of Miami Miller School of Medicine, who gave the drug to the first humans.

European patients account for most of the new cases and many of them might have been taking multiple drugs, raising their risk for PML, he added.

"This is not new information. We've had this information for a couple of months now [but] the labeling in the past did not make a distinction between the time frames that people were on the drugs," said Dr. John Richert, executive vice president for research and clinical programs at the National Multiple Sclerosis Society. "The risk-benefit ratio continues to be about the same as we anticipated since the time the drug was brought back on the market."

Another expert agreed that the clinical picture hasn't been altered by the new label warning.

"I think as long as the medication is being prescribed for the appropriate patient with MS, then the new information we have today is not going to alter medication management," said Dr. Jeffrey Tramonte, director of neurology at the Scott & White University Medical Campus in Round Rock, Texas. "Right now, Tysabri is the most efficacious drug that's ever been approved for the treatment of relapsing-remitting MS, which represents 85 percent of all patients out there who have MS," he said.

"However, it also carries the single most dangerous risk factor, and that's PML," added Tramonte, who only gives Tysabri if his patients have failed or have severe side effects from conventional immunomodulating drugs.

Natalizumab (Tysabri) first received FDA approval in November 2004, only to be pulled from the market three months later after several patients in clinical trials developed PML.

In June 2006, the FDA allowed the drug back on the market, but with strict conditions. According to those revised guidelines, Tysabri can only be administered by approved doctors, at infusion sites and at pharmacies that register and comply with a patient-safety program called CD Touch, designed by drugmaker Biogen Idec and approved by the FDA.

The FDA said the new action was based on reports of 31 confirmed cases of PML as of Jan. 21, 2010.

Information on the risk will also be included in the patient Medication Guide.

However, the FDA did not suggest discontinuing the drug, stating that it "believes that the clinical benefits of Tysabri continue to outweigh the potential risks."

The drug was approved to treat Crohn's disease in early 2008. It is also linked with liver damage. Patients do take the drug long-term, Richert said.

More information

Visit the National Multiple Sclerosis Society for more on this disease.



SOURCES: John Richert, M.D., executive vice president, research and clinical programs, National Multiple Sclerosis Society, New York City; William Sheremata, M.D., professor emeritus, neurology, University of Miami Miller School of Medicine; Jeffrey Tramonte, M.D., assistant professor, internal medicine, Texas A&M Health Science Center College of Medicine, chief, medicine, and director, neurology, Scott & White University Medical Campus, Round Rock, Texas; Feb. 5, 2010, statement, U.S. Food and Drug Administration


'/>"/>
Copyright©2010 ScoutNews,LLC.
All rights reserved

Related medicine news :

1. Child-specific doses for pediatric PET patients
2. Overdoses From Prescription Painkillers on the Rise
3. More Than 4 Million Doses of H1N1 Vaccine Allocated to Pennsylvania Since Start of Vaccination Effort
4. Nearly 5 Million Doses of Nasal Swine Flu Vaccine Recalled
5. Variable Doses of Radiation Raise Safety Concerns for CT Procedures
6. Nearly 3 Million Doses of H1N1 Vaccine Allocated to Pennsylvania since Start of Vaccination Effort
7. Heart Failure Drug May Help More in Higher Doses
8. Medical Tests Hit Heart Patients With High Doses of Radiation
9. FDA Initiative Seeks to Reduce Accidental Overdoses
10. 1 Million More Doses of Swine Flu Vaccine on Hand
11. New research suggests how low doses of radiation can cause heart disease and stroke
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/13/2017)... ... October 13, 2017 , ... The International Association of ... of excellence for the field of eating disorders, announces the opening of early ... in Orlando, Florida at the Omni Resort at ChampionsGate. , The ...
(Date:10/13/2017)... ... 2017 , ... Apple Rehab Shelton Lakes , which specializes in the ... facility as part of a disaster drill on October 3rd. , Apple Rehab participated ... Emergency Manager, as well as the Connecticut Long Term Care Mutual Aid Plan ...
(Date:10/13/2017)... ... 13, 2017 , ... Global Healthcare Management’s 4th Annual Kids Fun Run brought ... This free event, sponsored by Global Healthcare Management’s CEO, Jon Letko, is aimed at ... towards children of all ages; it is a non-competitive, non-timed event, which is all ...
(Date:10/13/2017)... ... 2017 , ... “The Journey: From the Mountains to the Mission Field”: the ... in the Philippines. “The Journey: From the Mountains to the Mission Field” is the ... She has taught all ages and currently teaches a class of ladies at her ...
(Date:10/12/2017)... ... October 12, 2017 , ... Planet Fitness, one of the largest and ... plans to open a flagship location in Covington, LA at 401 N. U.S. Highway ... store next to Office Depot in the Holiday Square shopping center. Its location allows ...
Breaking Medicine News(10 mins):
(Date:10/11/2017)... IRVING, Texas , Oct. 11, 2017  Caris ... science focused on fulfilling the promise of precision medicine, ... Institute has joined Caris, Precision Oncology Alliance™ (POA) as ... leading cancer centers, the St. Jude Crosson Cancer Institute ... to advance the use of tumor profiling, making cancer ...
(Date:10/10/2017)... 2017  NDS received FDA 510(k) clearance in May 2017 for ... stand specifically designed for endoscopy environments. An innovative secondary monitor solution, ... solution to support the improvement of patient outcomes, procedural efficiency, and ... ... ...
(Date:10/5/2017)... , Oct. 5, 2017  In response to ... Oral and Maxillofacial Surgeons (AAOMS) released prescribing recommendations ... to be used as a first-line therapy to ... Recognizing the value ... White Paper "Opioid Prescribing: Acute and Postoperative Pain ...
Breaking Medicine Technology: