Navigation Links
Tysabri May Cause Liver Damage, Health Officials Say

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:
Related Image:
Tysabri May Cause Liver Damage, Health Officials Say
(Date:11/26/2015)... ... November 26, 2015 , ... WorldCare ... participated in the 61st annual Employee Benefits Conference. The Employee Benefits Conference was ... November 8th through Wednesday, November 11th, 2015. The conference was held at the ...
(Date:11/26/2015)... ... November 26, 2015 , ... Indosoft Inc., developer and ... an application server to improve system efficiency and reliability. , The new Q-Suite 6 ... these standards, the system avoids locking itself into a specific piece of software for ...
(Date:11/25/2015)... ... November 25, 2015 , ... ... the perfect dish and pleasing the palates of attendees is of the utmost ... dish to a seasonal get-together, give these recipes a try this holiday season. ...
(Date:11/25/2015)... ... November 25, 2015 , ... TyloHelo ... parts and accessories. , Sauna accessories help improve the bather experience in the ... From basic styles for the purist looking for simplicity in design to accessories ...
(Date:11/25/2015)... Rouge, LA (PRWEB) , ... November 25, 2015 , ... ... in the United States District Court of Connecticut on behalf of a home health ... behalf of all current or former home health care workers employed by Humana, Inc., ...
Breaking Medicine News(10 mins):
(Date:11/26/2015)... , Nov. 26, 2015 Research and ... of the "2016 Future Horizons and Growth ... Market: Supplier Shares, Country Segment Forecasts, Competitive Intelligence, ... --> --> ... of the Italian therapeutic drug monitoring market, including ...
(Date:11/26/2015)... 2015 ... the  "2016 Future Horizons and Growth ... Marker Testing Market: Supplier Shares, Competitive ... offering.  --> ) ... "2016 Future Horizons and Growth Strategies ...
(Date:11/25/2015)... SYDNEY , Nov. 26, 2015  The total global ... nearly 7% over 2015-2016. Latin America ... Asia , (excluding Japan ), is ... continues to face increased healthcare expenditure. In 2013-2014, ... expenditure declined from 43.5% in 2008-2009 to 41.2% in 2013-2014. ...
Breaking Medicine Technology: