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Friday, March 14, 2014 8:03 PM | CCSVI in Multiple Sclerosis Volg link
Please be warned. We do not know the real numbers of PML in Tysabri users. The eHealthMe.com numbers say 2,943 people out of 90,305 Tysabri users have PML (3.26%) But it could be even higher. A new post on This Is MS explains why.

"Brief background, I used to work in the FDA program that handled drugs monitored under the Risk Evaluation and Mitigation Strategy program. The FDA requires that if a death (or adverse event) arises from the drug, it must be reported. BUT, they do not require the drug companies to proactively obtain that information. So the only way we recorded death info is if the doctor causally calls about ordering forms, and just so happens to mention that the patient dies. We have to ask a series of questions about the patient to record it. Most doctors offices do not have the time to stay on the phone and discuss this information, so it doesn't get recorded. Every once in a while, a family member will call in to report it, but because it is a family member and not a medical professional, we have to refer them to the drug company, and who knows if they record that information. I am very suspicious that the cases of PML is much much higher than what is reported.
http://www.thisisms.com/forum/tysabri-antegren-or-natalizumab-f11/topic24412.html


Tysabri is a dangerous drug : Tysabri (Antegren or Natalizumab) - This Is MS Multiple Sclerosis...
www.thisisms.com
Brief background, I used to work in the FDA program that handled drugs monitored under the Risk Evaluation and Mitigation Strategy program. The FDA requires that if a death (or adverse event) arises from the drug, it must be reported. ...