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:1/13/2017)... ... January 13, 2017 , ... The 18th European Congress: Perspectives in ... March 3-4, 2017. This Congress is expertly designed to meet the educational needs ... with lung cancer. , Chaired by Dr. Giorgio V. Scagliotti, Professor of Oncology at ...
(Date:1/13/2017)... ... ... inventor from Pahrump, Nev., used an unsavory medical experience to think of a way to ... urine bag for a half year due to lazy bladder," he said. "Keeping these things ... better way to do this." , He then designed and created a prototype of the ...
(Date:1/13/2017)... , ... January 13, 2017 , ... Friday, January 13 ... of the game room, increasing the size of the location to 90,000 square feet. ... 8-hole mini golf course that takes customers on an educational tour of the historic ...
(Date:1/13/2017)... ... January 13, 2017 , ... As the nation watches this month’s transition ... colleges and schools of education across the country is urging a fundamental reconsideration of ... Principles released today, 175 deans sounded the alarm: “Our children suffer when we deny ...
(Date:1/13/2017)... ... January 13, 2017 , ... One way to obtain a green card is ... can show their work is in the national interest. There are two significant advantages ... be sponsored by an employer; and 2) the submission is made directly to the ...
Breaking Medicine News(10 mins):
(Date:1/12/2017)... -- BioPharmX Corporation (NYSE MKT: BPMX), a specialty pharmaceutical company developing ... this week,s Orlando Dermatology Aesthetic & Clinical (ODAC) Conference, which ... inflammation. The data will be shared in a ... at ODAC, which is being held Jan. 13-16 in ... ...
(Date:1/12/2017)...   TyrNovo , s NT219 drug candidate ... cancer drug resistance and would be ... NT219 is a novel proprietary ... ( IRS1/2 and STAT3) highly involved in ... .   NT219 has demonstrated ...
(Date:1/12/2017)... -- "Global Lung Cancer Vaccine Market & Pipeline ... trends in the global lung cancer vaccine market. ... available in the market. This report analyzes the ... in clinical pipeline and gives comprehensive clinical insight ... the lung cancer vaccines. Currently there are 9 ...
Breaking Medicine Technology: