Another Tysabri Brain Infection Reported: 8th PML Infection Since Re-Launch

Biogen Idec Inc. indicates that another multiple sclerosis patient may have developed a rare and potentially life-threatening brain infection known as progresive multifocal leukoencephalopathy from side effects of Tysabri.

This is at least the eighth case of the potentially fatal brain infection linked to the drug since it was reintroduced three years ago with more stringent prescription guidelines designed to limit the risk of patients developing the brain infection.

After Tysabri (natalizumab) was first introduced in 2004, it was pulled from the market in 2005 when at least three patients developed progressive multifocal leukoencephalopathy, two of whom died. The drug was re-introduced in July 2006 with stronger warnings about the potential Tysabri brain infection risk and was only made available under strict usage guidelines.

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Tysabri is an intravenous injection administered every 28 days to treat multiple sclerosis or Crohn’s disease. It is manufactured and distributed jointly by Elan Corporation and Biogen Idec, with sales of approximately $165 million in the first quarter of 2009.

Progressive multifocal leukoencephalopathy, commonly referred to as PML, is a very rare brain infection that can cause damage and inflammation of the brain’s white matter in multiple areas. The infection is untreatable, and often results in death, following degradation of certain brain functions that can include a loss of vision, weakness, paralysis, impaired speech and cognitive decline.

Tysabri is one of several drugs that have been linked to reported PML brain infections in recent months.

In April, Genentech Inc. issued a Raptiva recall for their psoriasis drug after at least three confirmed cases and one suspected case surfaced. Several Raptiva lawsuits have been filed or are being investigated throughout the United States for users of the drug who developed PML or other opportunistic infections prior to the recall.

The cancer drug Rituxan has also been linked to PML deaths, leading the FDA to review whether users of the drug should take “drug holidays” or time off from using the drug, to reduce the risk of the infection developing. In May 2009, a study in the medical journal Blood linked 57 cases of PML brain infections to Rituxan and indicated that the infections had a 90% fatality rate among those users.

CORRECTION: The original story incorrectly indicated that this case was the eighth death from PML associated with the use of Tysabri. Only one of the eight patients diagnosed with PML after the re-introduction of Tysabri have died. We apologize for this error and any confusion it may have caused.

9 Comments

  • ChrisMarch 25, 2010 at 2:46 am

    Having been living with MS since 2004, I have been on Rebif, Avenox, and now Tsyabri. While I truly feel for all of the people who have been negatively impacted by this drug, I must say that I personally have responded quite well to it. I receive 2 MRI's per year, and I haven't had any new activity or active lesions since 07. My point is simple, I think that with everything there is going to be[Show More]Having been living with MS since 2004, I have been on Rebif, Avenox, and now Tsyabri. While I truly feel for all of the people who have been negatively impacted by this drug, I must say that I personally have responded quite well to it. I receive 2 MRI's per year, and I haven't had any new activity or active lesions since 07. My point is simple, I think that with everything there is going to be "risk." There are too many unknown variables about these cases of PML. Perhaps their body composition reacted with the drug? Point is, there is no way of knowing. If we look at the current data, 1/6500 patients contract PML who are taking Tysabri. This number is hardly alarming enough to stop this treatment! We must look at the "greater good" that this drug is providing to our society. While we continue to look for a cure, all we can do is hope. Tysabri has been beneficial to me and my family, and thanks to this drug, I can see the progression and advances being made in the very research that will one day let us all live in a world free of MS!

  • TracieJanuary 20, 2010 at 3:05 pm

    This is an awesome testimonial to natural health. Bravo! Your family member is in my prayers.

  • MattJanuary 17, 2010 at 1:10 pm

    Hi… my name is Matt. I was diagnosed with MS 2 years ago. There are two people in my family on my wife’s side, that have MS. One is in the hospital right now because of Tysabri! They have tried everything to save him. He is on chemo treatment as of yesterday. I think the number of people who contract PML is higher than they say. Just like the number of people with MS is higher than they say. There[Show More]Hi… my name is Matt. I was diagnosed with MS 2 years ago. There are two people in my family on my wife’s side, that have MS. One is in the hospital right now because of Tysabri! They have tried everything to save him. He is on chemo treatment as of yesterday. I think the number of people who contract PML is higher than they say. Just like the number of people with MS is higher than they say. There is a reason for that. Google: The Orphan Drug ACT, introduced to Congress 1993. I do not take any of their drugs. They say MS is such a mystery. Well…disease is not a mystery. All disease originates from four things: 1.You have too many toxins in your body 2.You have nutritional deficiencies. 3. You are exposed and effected by electromagnetic chaos. 4.You have trapped mental and emotional Stress. I know I had 3 of the 4 listed. These are the only four reasons why your immune system could be weak or why genetically weak areas in the body can break down, thus allowing illness and disease to develop. I ordered my Avonex from Biogen Idec when I was diagnosed. Then I read the fine print. There was no way I was injecting Chinese Hamster ovarian cells mixed with imbulim into my body. There is a way to cure yourself! Don’t let them tell you there is no cure. You see, If people can heel themselves they are out of work. You have to stop eating what your eating. Only eat Organic. Get 15 colonics in 30 days. Don’t drink alcohol. No Sugar. No dairy. Pray everyday. Stay positive. I have read over twenty books on natural cures and alternative therapy, because conventional methods are poisonous. Your liver is burdened with toxic medication, never giving the body a chance to heal. Your body wants to remain in homeostasis. Get a PH test Kit. Get your Vitamin D levels checked. Fix those 2 things, and virtually no disease organisms can live. Read “Spontaneous Healing”, “The Makers Diet”, Natural Cures They Don’t Want you to Know About” Overall health starts in the gut. We have to restore health in our digestive systems. There are countless books on how to do this. I can go on all night. I want to help people understand that they have the power to heal themselves. My first serious symptom of MS was Vertigo. I could not walk 3 feet without vomiting. I became so dehydrated I ended up in the hospital. I did a round of steroids for five days. Then I went on a raw vegetable diet for 20 days. Instantly helped. I read Anne Boroch’s “Curing Ms”. Gave me the hope and inspiration I needed to get me where I am today. NO symptoms. Feeling great! Oh! “But your brain can still shrink, your lesions can still grow, It can come out of nowhere” BS! Not if you Stop what you are doing and change the way you are living. You may think your healthy, but there are poisons in every food off the shelf. Change your thoughts. Fill your heart with love. I am so sad! and pissed! that I have a family member in a dire situation. He had just begun to listen to me. I am trying to reach all of you

  • DaveJune 18, 2009 at 9:56 pm

    Good points about some of the patients dying and not all of the Tysabri patients dying. Also good points about the news only presenting the bad but... You made a point about the vast improvements that isn't a complete truth though. There is no head to heada evidence that this product is better than standard treatment in MS but there is strong evidence that it has a higher risk of death and in M[Show More]Good points about some of the patients dying and not all of the Tysabri patients dying. Also good points about the news only presenting the bad but... You made a point about the vast improvements that isn't a complete truth though. There is no head to heada evidence that this product is better than standard treatment in MS but there is strong evidence that it has a higher risk of death and in MS usually patients have a long life span.

  • andreaJune 16, 2009 at 5:39 pm

    At first I will say sorry for my english... i´m German tys-patient. The second is: thank you lawsuits.com for the informations. I have now 16 tys-infusions with no improvements, but also I dont know how it could be without tys. But what I know is: I myself will everytime get informations about the development refer to the PMl-cases/PML-risk. Only then I have the chance to decide the pros and [Show More]At first I will say sorry for my english... i´m German tys-patient. The second is: thank you lawsuits.com for the informations. I have now 16 tys-infusions with no improvements, but also I dont know how it could be without tys. But what I know is: I myself will everytime get informations about the development refer to the PMl-cases/PML-risk. Only then I have the chance to decide the pros and cons about this medicament. It should be always my own decision. But the company will finish the PML-weekly update at the end of July. And than? Where we could get the possibility to form an impression about the ongoing pml-risks? Although:... the weekly pml up-dates are in any case marked in investor relations... they don´t inform the "patients".... This is a very bad handling with "consumers"... they only should bring the money. Many greetings from Germany

  • ScottJune 16, 2009 at 3:28 pm

    Improvments can be the feeling in my fingers has returned or now much improved walking. the negative of PML is often death. How can you not think about, talk about, and consider what can happen.

  • ClayJune 16, 2009 at 9:08 am

    Thank you for correcting the above article. Nevertheles quoting from Irish stockbrokers "As of March 2009, some 52,000 patients had been exposed to Tysabri since re-launch, implying an incidence of approximately 1/6,500. This remains comfortably within the 1/1,000 guidelines provided on the product labelling. " * So I fail to understand the point of your article in relation to Tysabri.,which has[Show More]Thank you for correcting the above article. Nevertheles quoting from Irish stockbrokers "As of March 2009, some 52,000 patients had been exposed to Tysabri since re-launch, implying an incidence of approximately 1/6,500. This remains comfortably within the 1/1,000 guidelines provided on the product labelling. " * So I fail to understand the point of your article in relation to Tysabri.,which has been proven to be a life changing powerfull drug whose risk profile continues to be on the decline. *http://www.davy.ie/Generic?page=MorningNews4)

  • RinaJune 15, 2009 at 9:24 pm

    Why can't we hear of the improvements of Tysabri instead of the negative affects it has???? Why does everyone focus on the bad and not the good?

  • DavidJune 15, 2009 at 5:38 pm

    Your information on PML deaths associated with Tysabri treatment since it was reapproved by FDA is incorrect. There has been just one (1) death confirmed by Biogen Idec, and patients with the other seven reported PML cases have survived, with varying degrees of disability. At least one patient has gone back to work, and another patient is about to, according to public comments from Biogen Idec l[Show More]Your information on PML deaths associated with Tysabri treatment since it was reapproved by FDA is incorrect. There has been just one (1) death confirmed by Biogen Idec, and patients with the other seven reported PML cases have survived, with varying degrees of disability. At least one patient has gone back to work, and another patient is about to, according to public comments from Biogen Idec last week. One must also appreciate the tens of thousands of MS and Crohn's patients whose quality of life has vastly improved due to Tysabri. This is the most effective treatment available, and although it has a very small level of risk, that risk is much less than the risk of poorly treated MS or untreated MS.

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