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:8/16/2017)... ... August 16, 2017 , ... ... in AED (Automated External Defibrillator) machines to their local business community, Riverfront Fitness ... Arrow Benefits Group. AED machines are an integral part of treating those suffering ...
(Date:8/16/2017)... , ... August 16, 2017 , ... ... annual all-encompassing awards program which recognizes organizations that demonstrate the core values of ... comprehensive award categories. , “As a global company, we are expanding our presence ...
(Date:8/16/2017)... , ... August 16, 2017 , ... “God Will Break Every Chain”: an inspirational story ... Chain” is the creation of published author, Evangelist Joann Shivers, a writer and a woman ... was on her life at an early age. She was born and raised in ...
(Date:8/16/2017)... ... ... is the creation of published author, Karen F. Norton, preacher, teacher, author, and speaker who ... “I froze between the half walls, shelves on my right and left. Small green dishes ... day on proud display in my dining room hutch; it reminds me of her every ...
(Date:8/15/2017)... (PRWEB) , ... August 15, 2017 , ... ... PhD, announced at his Inauguration that WesternU will move forward in bold new ... compass. , WesternU combined Wilson’s Inauguration ceremony with Convocation, the traditional opening of ...
Breaking Medicine News(10 mins):
(Date:8/15/2017)... -- AOTI Inc. announced today that its fully owned USA ... New York City Office in Yonkers, New York ... Oxygen (TWO 2 ) homecare therapy. This new East Coast location ... (ACHC) under the company,s DMEPOS accreditation for Home/Durable Medical Equipment Services. ... Advanced Oxygen Therapy Inc. ...
(Date:8/8/2017)... 2017  BioLineRx Ltd. (NASDAQ/TASE: BLRX), a clinical-stage biopharmaceutical ... financial results for the second quarter ended June 30, ... quarter 2017 and to date: ... for the Company,s lead project, BL-8040: ... BL-8040 as novel stem cell mobilization treatment for autologous ...
(Date:8/7/2017)... Mich. , Aug. 7, 2017 Diplomat Pharmacy, ... of Joel Saban as president, effective Aug. 7, ... Urick has decided to pursue other interests and will ... "During his tenure, Paul has served us in multiple leadership ... Specialty Pharmacy in Jun. 2015 and has provided decisive, strategic ...
Breaking Medicine Technology: