Researchers said Tysabri; a popular drug for multiple sclerosis appears to promote a rare brain infection by suppressing immune system cells in the brain. This has resulted in the death of a multiple sclerosis patient who had been taking Tysabri exclusively for 26 months.
Multiple sclerosis is a muscle-wasting, auto-immune disease in which the body mistakenly attacks the fatty myelin coating surrounding nerve cells. Biogen Idec and Irish drug maker, Elan Corp. manufacture the drug Tysabri, known generically as natalizumab. The drug is said to cause a serious brain infection called progressive multifocal leukoencephalopathy or PML.
An autopsy conducted by the researchers on an MS patient who died while taking the drug, led them to conclude that it might make the drug safer by giving patients treatment "holidays" from time to time in order to allow the brain's immune protection to recover.
In a statement Dr. Olaf Stuve, a neurologist at the University of Texas Southwestern Medical School in Dallas said, "Whether or not treatments other than prolonged, uninterrupted dosing may benefit patients with MS should be tested in controlled clinical trials,"
Stuve and colleagues wrote in the Archives of Neurology that they found reduced immune cells called CD4 T cells in and around the patient’s blood vessels in the brain. He said that in an attempt to reduce damage from MS the drug could promote infection in some people. "Natalizumab is very effective in keeping pro-inflammatory cells out of the brain to reduce damage from MS." Biomarkers which are easily tested indicators should be looked for by doctors as an indication that patients on the drug may be developing the syndrome and should be taken of the drug he added.
"It's a very effective drug, and it's clear that the vast majority of patients are greatly benefiting from its use," Stuve said.
Tysabri was introduced in 2004 and withdrawn in February 2005 after three patients contracted a brain infection, two fatally. In early 2006 it was reintroduced as there was a paucity of good drugs for MS patients and it recorded sales of $597 million in the first three quarters of the year.
The drug’s label carries a warning that patients on the drug have a 1-in-1,000 risk of developing PML. The company claims that in clinical trials the drug produced a 68 % reduction in relapses.
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Tysabri
I think that this is not a good drug. The potential side effects are brutal, even if it does only afflict one in a thousand. I am a MSer and have been offered Tysabri several times, only to have PML cases coincidentally appear mere days before taking the pharmaceutical.
When Tysabri is down to a one in twenty thousand chance for PML, I will consider taking it. But until then, I am not anyones guinea pig.
Tysabri
I was disgnosed with MS over 20 years ago and never took or was advised of any DMT until i had a major relapse in 2005. I was hospitalised for 6 mths and managed to pull through. Since then i have learned of Tysabri and have been taking it monthly since oct/2006 with no side effects. I can safely say that Tysabri has allowed me to live a good quality of life.
Tysabri
I know that Tysabri is an excellent drug. All drugs have side effects, but it is always nice when the benefits outweigh the risks. After 72 infusions I still remain relapse free, my disease progression has slowed down significantly and my MRI's look great. I thank God for this therapy and for what it has done for me! I often wonder where I would be today if I had not accepted this opportunity that has given me my life back. I'm moving forward despite the fact that I live with MS on a daily basis. Be willing to try it and see what it can do for you. Statistically, a person may be more in a risk situation by just getting in a car and driving in traffic, but you do it because it gets you where you want to be.