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optimist wrote:I thought the risk of anaphalactic shock is in the first few infusions. Why would this only show up after one had been getting infusions for more than one year and thus in the two year data if it is indeed there?

A very good question indeed!!

Monoclonal antibodies, in general, present the greatest danger of anaphalactic shock during the first or second infusion. That's why the FDA insists on the highest level of warning for this class of drug (the black box, as it is called)

We simply don't know any of the circumstances around these two deaths of Tysabri infusions but hopefully someone can obtain this info and let us know the facts.

Harry

According to my neurologist, Tysabri is not black-boxed.

MichelleMM wrote:According to my neurologist, Tysabri is not black-boxed.

I believe that is quite correct. But monoclonal antibody drugs are very potent and many of them are. Taken by the wrong person at the wrong time can be dangerous and that's why the FDA places such a caution on them. Most people can take Tysabri and have little or no problem as far as an immediate reaction is concerned. Some, though, aren't as fortunate.

Harry

Over on the msworld message board one of the members just posted that she was turned down by her neuro for Tysabri because of her med sensitivity. They felt she was at high risk of an allergic reaction. I wonder if word is trickling down from Biogen about who should not get the drug.

Over on the drug company rep site they joke about how they have to have the crash cart there for the infusions. YIKES!!!

Peter

You guys, this is how mis-information spreads like wildfire.

Quote:
"Over on the drug company rep site they joke about how they have to have the crash cart there for the infusions. YIKES!!! "

If Ptwo is referring to cafepharma.com, I would take that information with a huge grain of salt. All of the posts are anonymous, and there's lots of sabotage by competing reps on the boards. I am currently addicted to that site, but purely for its entertainment value.

I don't get what all of the hysteria is over regarding infusion reactions either. There were reactions by several trial participants, so the protocol has been established that recipients have to stay for an hour after the first several infusions to make sure that another tragedy doesn't occur.
There was a problem during the trials, and now we have valuable information that will enable us to avoid another tragedy.

If you find it prudent to ask the practitioner who is administering your infusion whether or not they are prepared for an anaphylactic reaction, then do so. What else are you afraid of?

DenverCO

On a related aside, I think it is helpful to define "Anaphylactic Shock" :


Anaphylactic Shock

The severest form of allergy which is a medical emergency.... An often severe and sometimes fatal systemic reaction in a susceptible individual upon exposure to a specific antigen (such as wasp venom or penicillin ) following previous sensitization. Characterized especially by respiratory symptoms, fainting, itching, urticaria , swelling of the throat or other mucous membranes and a sudden decline in blood pressure.

From: http://www.hon.ch/Library/Theme/Allergy ... shock.html

This discussion is one of the most irresponsible I have seen on the web. There are no publicly disclosed deaths, very low side effects and tremendous benefits associated with Tysabri.

This has not stopped a couple of posters from creating a thread that looks like a competitor to Biogen wrote it post by post.

If the irresponsible parties would like to post solid evidence for their claims then please do so, but please refrain from McCarthy-like waving of pseudo-evidence.

Denver,

I don't get what all of the hysteria is over regarding infusion reactions either. There were reactions by several trial participants, so the protocol has been established that recipients have to stay for an hour after the first several infusions to make sure that another tragedy doesn't occur.
There was a problem during the trials, and now we have valuable information that will enable us to avoid another tragedy.

I'm not sure that I would call the concern over serious reactions as being portrayed as "hysteria". We all know that everyone reacts differently to drugs and Tysabri is no exception. But because this drug is a monoclonal antibody, a lot more caution has to be taken with it than with any previous MS medication. Having the patient stay at the infusion site for an hour will certainly reduce the risk significantly but it won't guarantee that another fatality will never happen.

I sure wish that Biogen would have told the public about these incidents as opposed to having it slip out the way it has. And when this happens the chances of the facts being distorted are very high and rumors will abound.

Harry

MeadowStream wrote:This discussion is one of the most irresponsible I have seen on the web. There are no publicly disclosed deaths, very low side effects and tremendous benefits associated with Tysabri.

That's right...no "publicly" disclosed deaths. What we have so far is the comment from a MS professional on another website who was told by a Serono rep that two patients died from Tysabri infusions. And this person called a Biogen rep to check out the info and it was confirmed.

Now there are two possibilities here....the story is a total hoax or it is true. If a hoax, then an irresponsible release of information has taken place without any kind of verification. If it is true...well, everyone will have to determine their own reaction to it.

Knowing the source, I'm leaning towards it being true but I'm sure we'll know soon enough.

Harry

So the 1 year data does not mention any deaths though? Does this mean that there weren't any in the first year?

So even if people were being infused now before we get our hands on the 2nd year data, we at least know that we'll have that data before any of US hit our 2nd year on the drug, so we can still assess our risks if that's the case.

I wish we had a source of accurate information. Can we write or phone to the biogen folks and just ask them? I just don't like this "I heard this from so and so who heard it from so and so". I already feel that getting accurate information is a bit like playing cat and mouse.

How can we just get the facts - what are the risks of the drug and what exactly is the drug's efficacy on the average MS population, i.e., those who have had it for a number of years, and have some disability.

I just really want to get the straight goods so I can decide what to do about it. It looks so promising, yet the neuro's are delaying getting their patients on it until further information is available or they can see how it's working in the general MS population. Why is that?

BTW, does anyone know how the price for Tysabri compares to that for other monoclonal antibodies? Are we getting fleeced again?

Peter,

Are those 2 patients from the placebo group or from the Tysabri group?
Or perhaps one in each group?
.

From what I read they are both from the Tysabri group. Hopefully they will soon release the full phase III data and shed some light on just what happened,

.
From tysabri.com

Other hypersensitivity reactions were observed in 1% of patients receiving TYSABRI®.
Serious systemic hypersensitivity infusion reactions occurred in <1% of
patients.
All patients recovered with treatment and/or discontinuation of the infusion.

http://www.tysabri.com/product.html
.

You are getting accurate information from the FDA and the companies who make and marke Tysabri. What you are getting here is a couple of people yelling "Fire" in a crowded theater and excusing themselves because they contend that someone whispered it (not sure who or can't say) nearby.

Tysabri has been infused into human beings for 7 years with zero deaths due to drug. 7 years is a long time.

Note that no one is privileged with information about who is and who is not receiving drug in the 2ble blinded trials. No one. Not the doctors, not the patients, not the company. There is a 3rd party, bound by professional ethics and secrecy, whose whole purpose for being is to correlate numbers of vials to numbers of patients and patient numbers to patient names - that is the only entity that could know who is getting what.

The safety and side effect profile of Tysabri is unmatched by any MS drug, and even by few drugs anywhere for any indication. I do not know why there is an attempt to discredit Tysabri on this thread, but you can probably make your own guesses.

Better,

Was this data taken from the two trials of one year data that was used for FDA approval? We haven't seen any two year data from the other 97 world-wide Phase III trials.

Harry