Navigation Links
Tysabri May Cause Liver Damage, Health Officials Say
Date:2/27/2008

MS drug also used to treat Crohn's disease can show injury in as little as 6 days

WEDNESDAY, Feb. 27 (HealthDay News) -- The controversial multiple sclerosis drug Tysabri can start causing liver damage within six days of the first dose, U.S. health officials said Wednesday.

In January, the U.S. Food and Drug Administration expanded the use of Tysabri to treat Crohn's disease, a chronic inflammation of the digestive tract.

The drug has also been linked with serious brain infections in multiple sclerosis patients, as well as liver damage.

When the FDA granted approval to use Tysabri for Crohn's disease, it asked the manufacturers -- Biogen Idec of Cambridge, Mass., and Elan Corp. -- to send letters to health-care providers about the potential problems with liver toxicity.

"This [the Biogen Idec letter] was part of the approval of Jan. 14," said FDA spokeswoman Rita Chappelle. "The manufacturer was going to send out a notice to health-care providers to make them aware of the potential problem."

A warning about the danger of Tysabri to the liver is already on the product label.

"FDA does not require 'Dear Doctor Letters,' but can request that a sponsor send one to inform health-care practitioners about new adverse events that are labeled," Chappelle added.

According to the letter from Biogen Idec, the drug should be stopped or discontinued if patients become jaundiced or have other evidence of liver damage.

Tysabri (natalizumab), a monoclonal antibody used to treat MS, has been under a cloud of controversy for some time. The drug works by attaching itself to white blood cells called lymphocytes and preventing them from entering the brain, where they do damage that causes the disabling symptoms of MS.

But the drug has a checkered past. It first received FDA approval in November 2004, only to be pulled from the market three months later, after several patients in clinical trials developed a rare but deadly viral infection of the brain called progressive multifocal leukoencephalopathy.

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 pharmacies that register and comply with a patient-safety program called CD Touch, designed by Biogen Idec and approved by the FDA.

More information

For more on Tysabri, visit the U.S. Food and Drug Administration.



SOURCE: Rita Chappelle, spokeswoman, U.S. Food and Drug Administration


'/>"/>
Copyright©2008 ScoutNews,LLC.
All rights reserved  

Related medicine news :

1. Stopping Tysabri May Worsen MS
2. MS Drug Tysabri Approved for Crohns Disease
3. Drug for cluster headaches may cause heart problems
4. Study Points to Cause of Vioxx Heart Risk
5. Damp, Moldy Homes May Cause Depression
6. Constipations Many Causes and Cures
7. High Co-Pays Cause Seniors to Go Without Meds
8. 13 percent of women stop taking breast cancer drug because of side effects, U-M study finds
9. Vocal cord dysfunction may be caused by work
10. Study finds drug spending caps cause some seniors to quit taking key medicines
11. Medicare Spending Caps Cause Seniors to Stop Meds
Post Your Comments:
*Name:
*Comment:
*Email:
Related Image:
Tysabri May Cause Liver Damage, Health Officials Say
(Date:6/25/2016)... ... June 25, 2016 , ... Conventional wisdom preaches the ... In terms of the latter, setting the bar too high can result in disappointment, ... just slow progress toward their goal. , Research from PsychTests.com reveals ...
(Date:6/24/2016)... ... June 24, 2016 , ... Those who have experienced traumatic events may ... to unhealthy avenues, such as drug or alcohol abuse, as a coping mechanism. To ... for healthy coping following a traumatic event. , Trauma sufferers tend to feel a ...
(Date:6/24/2016)... ... ... was in a crisis. Her son James, eight, was out of control. Prone to extreme ... “When something upset him, he couldn’t control his emotions,” remembers Marcy. “If there was ... other children and say he was going to kill them. If we were driving ...
(Date:6/24/2016)... ... June 24, 2016 , ... Global law firm Greenberg Traurig, P.A. ... The attorneys chosen by their peers for this recognition are considered among the top ... Shareholders received special honors as members of this year’s Legal Elite Hall of Fame: ...
(Date:6/24/2016)... ... June 24, 2016 , ... Comfort Keepers® of San Diego, ... and the Road To Recovery® program to drive cancer patients to and from their ... to ensure the highest quality of life and ongoing independence. Getting to and ...
Breaking Medicine News(10 mins):
(Date:6/23/2016)... 2016  MedSource announced today that it has ... solution of choice.  This latest decision demonstrates MedSource,s ... their clients by offering a state-of-the-art electronic data ... nowEDC as the EDC platform of choice in ... "nowEDC has long been a preferred EDC platform ...
(Date:6/23/2016)... DUBLIN , June 23, 2016 ... the "Pharmaceutical Excipients Market by Type (Organic Chemical ... Preservative), Formulation (Oral, Topical, Coating, Parenteral) - Global Forecast ... The global pharmaceutical excipients ... 2021 at a CAGR of 6.1% in the forecast ...
(Date:6/23/2016)... Research and Markets has announced the addition of ... Forecast to 2022" report to their offering. ... date financial data derived from varied research sources to present ... impact on the market during the next five years, including ... sub markets, regional and country level analysis. The report provides ...
Breaking Medicine Technology: