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Study shows ms patients at most risk for drug-linked brain illness by ferujkll sdff
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Study shows ms patients at most risk for drug-linked brain illness |
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Business,Business News,Business Opportunities
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Small number of Tysabri users develop rare but potentially fatalinfection. By Randy Dotinga HealthDay Reporter WEDNESDAY, May 16 (HealthDay News) -- Drug company researchers saythey've determined which multiple sclerosis patients are mostvulnerable to developing a rare brain infection while taking apowerful drug called Tysabri (natalizumab). Even the multiple sclerosis patients at highest risk of developingthe brain infection face low odds of getting it while on Tysabri,but the infection can be deadly. "Now we can identify which risk group each patient is in.
This willhelp doctors and patients make better decisions," said Dr. GaryBloomgren, lead author of a study released Wednesday and vicepresident of drug safety at Biogen Idec, which makes the drug. About 100,000 patients have taken Tysabri at least once. The drug,which is used mainly to delay the progression of multiplesclerosis, has been on the market since 2006. It originally went onthe market in 2005 but was removed due to medical problems thatsome patients encountered, Bloomgren said.
Tysabri is expensive, costing about $40,000 a year. It dampens theimmune system, potentially reducing the inflammation that is amajor part of multiple sclerosis. Dampening the immune system,however, can allow an infection known as the JC virus to wreakhavoc on the brain and cause a condition called progressivemultifocal leukoencephalopathy. The JC virus is extremely common, affecting about half of adults bymiddle age, but the immune system normally keeps it under controlso it causes no symptoms.
If unleashed, however, progressivemultifocal leukoencephalopathy can cause cognitive problems, suchas unusual behavior, paralysis and problems with vision, speech andbalance, said study co-author Dr. Sandra Richman, senior medicaldirector at Biogen Idec. Once the symptoms appear, doctors usually advise patients to stopthe treatment, she said. Progressive multifocal leukoencephalopathyoften causes permanent disability, and can be deadly. In 2010, the U.S Food and Drug Administration added a new warningabout the rare brain infection to Tysabri's label.
The drug also isused to treat Crohn's disease. In January, the FDA approved a test to determine the risk of braininfection in Tysabri users. In the new study, the researchers examined various statistics tofigure out which multiple sclerosis patients were at highest riskof progressive multifocal leukoencephalopathy if they take Tysabri.Blood samples of nearly 5,900 patients with multiple sclerosis wereanalyzed. Just more than 1 percent of patients showed signs of exposure tothe JC virus, had taken immune-suppressing drugs before Tysabri andhad been on Tysabri for 25 to 48 months. The risk for those who hadn't been exposed to the JC virus was 120times smaller at 0.009 percent.
Patients who worry about progressive multifocal leukoencephalopathy"may think about it differently because of the low risk in thatsubgroup of patients," Bloomgren said. Multiple sclerosis patients who have been exposed to the JC virusbut haven't taken immune-suppressing drugs while on Tysabri maychoose to continue taking the drug, said Dr. Scott Zamvil, aprofessor of neurology at the University of California-SanFrancisco. "Patients who are on the drug don't want to come off because it'sthat potent of a drug," he said.
"It is the most potent of thecurrently approved drugs." Patients need to talk to their physicians and weigh the benefit ofthe medication versus the potential risk, Zamvil said. The study appears in the May 17 issue of the New England Journal of Medicine . More information For more about multiple sclerosis , try the U.S. National Library of Medicine.
SOURCES: Gary Bloomgren, M.D., vice president of drug safety, andSandra Richman, M.D., senior medical director, Biogen Idec,Cambridge, Mass.; Scott Zamvil, M.D., professor of neurology,University of California-San Francisco; May 17, 2012, New England Journal of Medicine Copyright © 2012 HealthDay . All rights reserved. I am Wires, Cables & Cable Assemblies writer, reports some information about deckle edge paper , skin packaging film.
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