Multiple sclerosis drug with lethal side effects approved by FDA panel

By Elizabeth Rhein

Published on April 06, 2006

In February of 2005, multiple sclerosis drug Tysabri was pulled from the market shortly after it was approved, after it was found to cause a rare brain disease called progressive multifocal leukoencephalopathy, or PML.

Now, in response to requests from both multiple sclerosis patients and their doctors, an FDA advisory panel has agreed to recommend that the FDA allow the drug to be returned to market. Proponents of the medication argue that the risk of PML is low enough (about one in 1,000) that patients and doctors should be allowed to choose between the risk of the brain disease and the considerable benefits offered by the drug.

There is no way to predict which patients will contract PML, although the federal committee believes strongly that combining Tysabri with other multiple sclerosis drugs increases the risk of getting the disease.

It is anticipated that the FDA will go along with the panel's recommendation.

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Keyword Tags: personal injury, pharmaceutical litigation, misc defective drugs

Comments

1

Do we have a case?

James Daniels, 6 days ago

2

Betaseron messed up the neroutransmitters in my brain and caused an chemical inbalance in my brain too. Had sezuire activity, tremmors , ansominia, short memory loss, it also affected my body as a whole, thyroid was high and it messed up my heart, from the tachycardia it caused. Went to the hospital becaue of it and the hospital said that it was from the betaseron. Told the neurologist before that i didn't want to take the betaseron any more and he neglected to listen to me when i was having problems. When we tried to call him when having problems, he never returned our calls. So had to go to the er, twice because of medication. They gave me stuff to counter act the interferon and come to find out they over prescribed that too. They added copaxone in the mix and had to go back to the er a second time. Still don't know if damage is perminant. My nerves were so hypersensitive, shaking so bad could not even hold a glass of water. The neuorlogist accused me of everything under the sun and this is all over town. This has been going on since april 08. also complained to the insurance company and the case is still under review. They don't return phone calls either. The harassment has been unbearable and they have broken hippa laws, invaded our privacy, this is all over town. Had spent almost $10,000.00 in co pays for the betaseron too. This is a total mismanagement of such a high powered medication. It is a biological responce inhibiter used to treat multiple sclerosis, which "supposedly"they say i have.

James Daniels, 6 days ago

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