PML Cases now reach 439!

[HarryZ]

Last month the number of Biogen reported Tysabri related cases jumped by 9 making the new total 439. Don't know if any more deaths are included in this number. Unfortunately, it just isn't getting any better.

http://chefarztfrau.de/?page_id=716

[centenarian100]

One would think that the number of new cases would go down with better risk stratification. Sadly, this does not seem to be the case

[HarryZ]

One would think that the number of new cases would go down with better risk stratification. Sadly, this does not seem to be the case

Yes, it makes you wonder if the risk information is really getting to the patients before they make a decision. So often, MS patients will rely totally on what their doc/neuro tells them. Those who use the internet extensively have the ability obtain many points of view on Tysabri but I still believe this group is very small when compared to all MS patients.

[centenarian100]

Yes, it makes you wonder if the risk information is really getting to the patients before they make a decision. So often, MS patients will rely totally on what their doc/neuro tells them. Those who use the internet extensively have the ability obtain many points of view on Tysabri but I still believe this group is very small when compared to all MS patients.

439 is small compared to the total number of tysabri treated patients, but it is a terrible enough disease that it is still very concerning.

[HarryZ]

439 is small compared to the total number of tysabri treated patients, but it is a terrible enough disease that it is still very concerning.

Small when you look at the total number of Tysabri users but what is concerning is the elevation of risk ratio after a couple of years use. Initially Biogen told us that the risk of PML was 1:2000. Now under certain conditions, it has gone up significantly ( about 1:150 if I can recall correctly)

Makes it difficult to decide whether to use the drug, especially if the neuro doesn't give you all the info surrounding it.

[ElliotB]

As more and more people are using the medication and more and more time passes, would you expect the number of cases to increase?

[cheerleader]

sorry for being a broken record---but that report is incomplete. EHealthme.com is an independent tracking site of after market side effects of drugs--and they report almost 3% of Tysabri users with side effects have PML.

On Feb, 23, 2014: 90,305 people reported to have side effects when taking Tysabri. Among them, 2,583 people (2.86%) have PML.

http://www.ehealthme.com/ds/tysabri/pml

The real numbers are not updated in real time, because of the way agencies report adverse effects. They FDA has only released info up to March 2013.

But doesn't the FDA issue these kinds of reports? Aren't they required to let us know? No, and Yes.
The FDA issues quarterly FAERS (adverse effects) reports, which are about 25MB of data on ALL the drugs and all the side effects. They do not have a searchable site. It is not for consumers. They do not have a database. Here are the files. http://www.fda.gov/Drugs/GuidanceCompli ... 082193.htm

[HarryZ]

Thanks Cheer,

I was going to mention these other numbers in my post but got involved in a phone call and forgot. That's what happens when you get older