Avonex Side Effects May Be Linked To Progressive Multifocal Leukoencephalopathy (PML) Lawsuits
Avonex | Lawsuits, Lawyers |Side Effects: PML (Progressive Multifocal Leukoencephalopathy), Mental Deterioration, Vision Loss, Speech disturbances
On February 28, 2005, the FDA reported people suffering PML (Progressive Multifocal Leukoencephalopathy) while taking Avonex. In many circumstances those who suffer from Multiple Sclerosis take both Avonex and Tysabri together. Tysabri was withdrawn from the market after recent reports of two cases of serious effects among patients who used it along with an earlier Avonex, in clinical trials. In one instance, the person died, while in another, the person developed a suspected case of Progressive Multifocal Leukoencephalopathy, a rare and frequently fatal disease of the central nervous system.
PML (Progressive Multifocal Leukoencephalopathy) often results in irreversible neurological deterioration and death. Both patients had taken Avonex for more than two years in combination with Tysabri, the companies said. Symptoms of PML (Progressive Multifocal Leukoencephalopathy) include mental deterioration, vision loss, speech disturbances, ataxia (inability to coordinate movements), paralysis, and, ultimately, coma reflecting the multifocal distribution of brain lesions. In rare cases, seizures may occur.
FDA warned that Avonex might cause severe liver damage
Avonex, manufactured by Biogen, Inc. was approved on May 17, 1996 to combat Multiple Sclerosis.
Biogen spokeswoman Amy Ryan said the change was a minor update to the Avonex label. She said the company had received very, very few reports of liver damage in Avonex patients, but declined to give specific numbers. It is a very rare issue, she said.
In 2004 Avonex, had $1.42 billion in sales.
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