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-   -   Tysabri Information & Check In (https://www.neurotalk.org/multiple-sclerosis/37891-tysabri-information-check.html)

tovaxin_lab_rat 03-21-2008 03:20 PM

Quote:

Originally Posted by RedPenguins (Post 241678)
So, as of now, I'm scheduled for APRIL 1st at 8:30am - AT THE LOCATION DOWN THE BLOCK FROM MY HOUSE!!

However, they told me that they weren't sure it would just be consult or consult and meds. So I have to wait to see if I can get both - though the TOUCH people seemed sure I would get the meds the same day.

OMG - can't breathe - can't believe it!

~Keri

YEAH Keri!

I am so happy that you have finally gotten approved!!!! Yippee!!!!

A squeaky wheel....:D

Riverwild 03-21-2008 07:13 PM

It's ABOUT time, Keri!!!

Thanks for stopping in and letting us know! Let us know what happens and when you get your first infusion. We are pulling for you!!!:)

lady_express_44 03-21-2008 10:35 PM

Quote:

Originally Posted by Riverwild (Post 227110)
The FDA released slides ahead of the Jul 31 panel for Tysabri in Crohn’s showing 28 unduplicated cases of liver injury when using Tysabri, with 4 being serious despite no liver injury signal being identified in Tysabri clinical trials. All 4 patients with serious liver injury fully recovered, with no deaths or liver transplants.


An update on the liver problems in a recently released Q & A document, as reported by EMEA (European Medicines Agency), on Mar 20th, 2008.

"What is the issue with Tysabri?

There have been reports of liver injury in patients receiving Tysabri. The term ‘liver injury’ is used to describe any side effect seen in a patient that could be a sign of the liver malfunctioning, such as raised levels of liver enzymes, yellowing of the skin or inflammation of the liver.

The European Medicines Agency (EMEA) is aware of 29 reports of liver injury in patients receiving Tysabri, with about two thirds of these cases being classified as serious.

The committee (NOTE: not USA) agreed that the product information should be updated to include information about the risk of liver injury. This includes warnings that patients treated with Tysabri should have their liver function monitored . . ."

http://www.emea.europa.eu/

http://www.emea.europa.eu/humandocs/...14590808en.pdf

RW, any idea why there is a discrepancy in the number of "serious" cases (4 mentioned in your prior posting) and 2/3 of 29 stated by the EMEA?

Cherie

Harry Z 03-21-2008 10:48 PM

Quote:

RW, any idea why there is a discrepancy in the number of "serious" cases (4 mentioned in your prior posting) and 2/3 of 29 stated by the EMEA?

Cherie
Hi Cherie,

And some people wonder why I voice my concern about Biogen!

Harry

tovaxin_lab_rat 03-21-2008 11:06 PM

Keri

I got a phone call from Biogen today. Interesting information! It certainly explains a lot and your approval today! ;)

sheena 03-22-2008 01:17 AM

Red, I am so happy for you. April 1st is good timing on the Dr appointment. It's about how long I had to wait. I told you when things move they move fast. Congats!!!!

sheena 03-22-2008 02:35 AM

Could I be too weak for Tysabri
 
Good before bad

The good news is I have not had any new MS symptons since my infusion. Everyday until I got Ty I was getting worse. Everyday I had a new MS something. Now (while it has only been 3 days) I feel stable. I am so happy, but scared of getting pulled off.

I have COPD and get sick a lot. I'm worried about getting pulled off of Ty. When I took the infusion I had a very minor cough. I know I was not supposed to take it but I had too. I was getting much worse w/ms. 2 days later, I was DX with Pneumonia. I need an educated guess - do you think my system may be too weak for Ty. I feel sure I would have got sick with something w/o Ty. I'm just not sure it would have been Pneumonia. What is your guess - was I coming down with Pneumonia or did my infusion possibly make it worse. I want to stress I am not worried about PML - so Harry stay way from my post. I'm looking for thoes on TY. Oh, they did not tell me what type of pneumonia I have and put me on avelox. Yes, I did tell the neuro Dr I was mild to mid stage COPD.

barb02 03-22-2008 07:49 AM

It is hard to say whether or not tysabri was the direct cause, but we know that it does weaken our immune system and we are more likely to have infections. Lung infections are listed a a possible side effect. I became sick about 5 days after my third infusion and eventually was dx with bronchitis and a sinus infection and took axelox for 10 days. An urgent care doctor prescribed this as I was out of state at the time. My pcp says it is a pretty strong antibiotic. I got the feeling he thought I should have been given something weaker. I think avelox is in the same class as cipro. I went on to have my 4th infusion just a few days after I finished the avelox. I am still having sinus problems, but the infection (if I ever really had one) is gone.

I think this is a decision that has to be made between you and your doctor. but you do need to be over the pneumonia before you have another infusion. You do need to be honest with him/her. I would think that he would probably want to give it a few more tries.

lady_express_44 03-22-2008 09:03 AM

Quote:

Originally Posted by Harry Z (Post 242037)
Hi Cherie,

And some people wonder why I voice my concern about Biogen!

Harry


Well, I suppose there's just as good a chance that the EMEA has messed up their facts . . . but either way, it proves the point that we aren't always getting reliable information from what we think would be reliable sources anyway. :cool:


Quote:

Originally Posted by sheena (Post 242101)
Good before bad


The good news is I have not had any new MS symptons since my infusion. Everyday until I got Ty I was getting worse. Everyday I had a new MS something. Now (while it has only been 3 days) I feel stable. I am so happy, but scared of getting pulled off.

I have COPD and get sick a lot. I'm worried about getting pulled off of Ty. When I took the infusion I had a very minor cough. I know I was not supposed to take it but I had too. I was getting much worse w/ms. 2 days later, I was DX with Pneumonia. I need an educated guess - do you think my system may be too weak for Ty. I feel sure I would have got sick with something w/o Ty. I'm just not sure it would have been Pneumonia. What is your guess - was I coming down with Pneumonia or did my infusion possibly make it worse. I want to stress I am not worried about PML - so Harry stay way from my post. I'm looking for thoes on TY. Oh, they did not tell me what type of pneumonia I have and put me on avelox. Yes, I did tell the neuro Dr I was mild to mid stage COPD.


The pneumonia came on just a day or two after the Tysabri infusion, and as I understand your posting, "every day leading up" to the infusion, you were getting worse . . . ?

I'm gonna go out on a limb here and suggest that you were in a psuedo exacerbation due to the pneumonia that you already had brewing, and that's why you had noticed the worse symptoms and minor cough.

When something similar happened to me last year (bronchitis + sinus infection), I was feeling absolutely MS-normal the day before, and sick as a dog the day the symptoms showed. But for the terrible chest pain, I couldn't believe it when they said I had bronchitis and needed antibiotics. Within a day, I was on the road to recovery too.

So my guess is, since your pneumonia dx came so SOON after the infusion, is quite possible that you had it before you even started on T, it just wasn't obvious yet.

BTW, a person does not have to be on Tysabri to offer a sensible educated guess. :cool:

Cherie

Harry Z 03-22-2008 10:23 AM

Quote:

I want to stress I am not worried about PML - so Harry stay way from my post. I'm looking for thoes on TY. Oh, they did not tell me what type of pneumonia I have and put me on avelox. Yes, I did tell the neuro Dr I was mild to mid stage COPD.
I would gladly stay away from your post but... I'm sure you know that pneumonia is a serious infection of the lungs. Tysabri alters the way your immune system functions. Just where is your Tysabri prescribing doctor who is supposed to be Touch Program certified in all of this? You are going on the internet to ask for information about a potentially serious situation with your health when you should be banging on your doc's door and getting some answers and treatment immediately! Please Sheena, tell us your doctor is totally aware of your situation and is taking some steps to handle it.

Harry


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