Group News

A place for users of Tysabri to discuss issue of Tysabri Use and also those interested in starting Tysabri.

 

I started this group when I was very uncertain about starting TY. My uncertainty was mainly financial because I was on a patient assistance program for my MS medication & I was frightened to give up the financial assistance I had to go to something I was uncertain I would be able to afford. I thought the decision to go TY would unltimately cost me too much and I would never qualify for Patient Assistance again. So I thought I might lose everything by going to TY. I just began inviting everyone who had posted at sometime that they used TY to find out what the future would hold for me if I went to TY.

 

I did start TY with much less anxiety because this group existed. Because of some very supportive members, talented members with people skills in this group. There are very "inconsequential" questions that a person needs to be able to ask and have answered to contain anxiety. The posts & replies answer many of these type of questions. So scroll back to earlier posts, there is a lot of information in those earlier posts. This group has  historical legacy of information in past posts & replies.

 

Any news that is posted about TY is posted here as a place to find out what's been happening with TY. A place to find this historical information. We all share what we know, so we all know more together than we do alone.

There are a range of members with many different lifestyles, that would welcome a contact from someone considering starting TY. I would like to name the people with experience that stands out, but that would be all, because all have something that stands out.

 

Early when I began this group I would get a notice whenever someone joined, so I would ask them what's happening in their life & try to match them with someone who had a similar situation going on. DS no longer sends me that notice of a new person that joined so I am not able to match people. I have to trust that new people will identify those with similar experience & understand that a personal contact by them is recieved and welcomed by any & all  members of the group.

 

I'm an information collecting hog so some past posts that stand out to me as useful for a new person to not pass by...there are many depending on the topic of interest, but two right now that stand out to me are...

 

Webcast on What is PML?

 

http://www.dailystrength.org/groups/tysabri-users/discussions/messages/6255531

 

www.researchchannel.org/prog/displayevent.aspx?rID=9219&fID=567

 

Link to a woman with much information on Tysabri because she was one of the people who testified to to the FDA Drug Advisory Comittee to get TY brought back to market after the FDA pulled it from market. She keeps her website up to date and knows a lot about TY and has been using TY for a long time.

 

http://www.dailystrength.org/groups/tysabri-users/discussions/messages/5766230

 

http://lauren-livingwithms-aolcomlglbgl2003.blogspot.com/

 

 

 

Infusion:

Questions before the infusion take about 10 minutes.Temperature & blood pressure are taken. The infusion is an hour then you have to sit and they have to watch u for an hour after the infusion to make sure u don't have a reaction. Every 3 or 4 months they will draw blood and check it before the questions. 

 

(My comment: The wait for 1 hour after the infusion is by FDA Regulation.) 

 

 

 

 

Links..... 
From nmss.org site.

Tysabri What You Need to Know featuring John Richert, MD
This video webcast series will focus on:

Part 1: The Basic Facts
Length of program: 13 minutes
Downloads: Transcript (.pdf) | Podcast (.mp3)

Topics:

History
Tysabri vs. Other Drugs
Safeguards
Balancing Risks and Benefits
Part 2: A Look at the Infusion Process
Length of program: 13 minutes

http://www.nationalmssociety.org/m...


Downloads: Transcript (.pdf) | Podcast (.mp3)

Topics:

Touch Program
Infusion Centers
Choosing Tysabri 

Reported quarterly. This section reports on the  FDA AERS system beginning the third quarter of 2006.

 Data Source:

www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/ucm082193.htm
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
 

9/16/2009 the FDA issued a notice stating that there have been 13 cases of PML confirmed with TY as a monotherapy, as of 9/8/09 with no cases before 12 infusions, and only 4 cases in the US. The average number of infusion for people with confirmed PML was 25 infusions.The risk MAY increase after 2 years."the current rate of PML in patients who have received at least 24 infusions ranges from 0.4 to 1.3 per 1,000 patients. At this time, the FDA is not requiring changes regarding PML to the Tysabri prescribing information or to the Tysabri risk management plan, called the TOUCH Prescribing Program."

 

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm107198.htm

 

A converstion of 0.4 -1.3 per 1,00 patients converted to a risk of 1...?

1 in 769 to 1 in 2,500 patientss.

Far from the days when it was 1 in 10,000 patients and getting rather close to 1 in 1,000 for after 2 years.

The FDA would change the label, not remove it from market again.

-------------------------------------------------------------------------------------------------------------------------------------

 

Possible PLM Cases investigated as reported by the FDA:
from 3rd Quarter 2006 through 1st Quarter 2009

On 9/16/09 FDA announced that as of 9/8/0 there were 13 cases of confirmed PML worldwide.

None before 12 infusions, only 4 in the US.

 

On 10/19/09 the European Medicines Agency announced 23 cases of confirmed PML worlwide.

 

On 10/23/09 the 24th case of confirmed PML as announced by the European Medicine Agency.

 

Abbreviations used:
Outcomes - DE-death,LT-Life-threatening,HO-hospitalization initial or prolonged,DS-disability,OT-other  
Occupatuion of Reporter -MD-physian,PH-pharmasist,OT-other health care professional,LW-laywer,

CW-consumer                                         

Report Method - EXP-expediated(15-Day) manufacture required to report event within 15 days of finding out, PER-periodic,DIR-direct                                            

 

 

    Summary(Approx): 34 PML Incidents,17F:16M:1?                                        
    Age: 2- 60's,7- 50's,12- 40's,4- 30's,6-20's 1-teens,1-?                                        
    Duration months:2-28,1-24,2-22,1-18,2-17,3-13,2-12,,,,,,,,,                                        
    Country:17-US,11-Germany,3-Sweeden,1-Canada,1-France,1-South Africa                                        
    Outcome: 4-DE,2-LT,2-DS,17-HO,8-OT                                    
                                            
(FDA Date,Event Date,AgeGender, TY Duration in mo.,Country,Outcome,Case#)(Reporter Occupation, Report Method)  

 

    2Q09    second quarter 2009                                                       
    34     (20090409,20090301,45F,28,GERMANY,HO,6964814)(MD,EXP)

    33     (20090428,20090416,40F,2,GERMANY,HO,6170312)(MD,EXP)

    32     (20090512,20090401,35F,22,US,HO,6991972)(MD,EXP)

    31     (20090527,20090501,25M,18,GERMANY,OT,6203419)(MD,PER)

    30     (20090624,20090510,27M,28,SWEEDEN,OT,7031751)(MD,EXP)                                     
    

    1Q09    first quarter 2009                                                                    
    29    (20090106,20081217,21M,11,US,OT,6873703)(MD,EXP)                                    
    28    (20090106,?,58F,13,US,DE,6880920)(CN,DIR)                                    
    27    (20090122,20080101,42F,11,GERMANY,LT,6888857)(MD,EXP)

    26    (20090319,20090219,45F,2,SOUTH AFRICA,HO,6945329)(MD,EXP)
                                    
    4Q08    fourth quarter 2008                                    
    25    (20081001,20080501,52M,12,GERMANY,HO,6727971)(OT,EXP)

    24    (20081014,20080801,49F,?,US,HO,6747026)(MD,EXP)                                    
    23    (20081020,20070501,53F,?,US,HO,6762356)(MD,EXP)                                    
    22    (20081009,20080821,43F,4,US,DE,6764743)(?,EXP)                                    
    21    (20081003,20080901,45F,?,US,HO,6787757)(MD,EXP)                                    
    20    (20081014,20080101,19M,2,GERMANY,OT,6796155)(MD,EXP)

    19    (20081022,20080101,32F,7,GERMANY,HO,6807213)(MD,EXP)

    18    (20081030,20081024,59F,13,US,HO,6808028)(MD,EXP)                                    
    17    (20081218,20081024,59F,13,US,DE,6815760)(OT,EXP)
    16    (20081121,20071016,52M,12,GERMANY,HO,6818256)(OT,EXP)
    15    (20081126,20081101,26F,?,GERMANY,OT,6823458)(MD,EXP)
    14    (20081226,20081101,57M,24,GERMANY,OT/HO,6832272)(MD,EXP)
    13    (20081223,20070401,37M,17,SWEEDEN,DS,6864953)(MD.EXP)
    12    (20081223,20080701,45M,10,US,HO,6864962)(MD,EXP)
    11    (20081224,20081201,23M,6,GERMANY,LT,6866349)(MD,EXP)

    3Q08    third quarter 2008
    10    (20080731,20080220,63M,6,US,HO,6615520)(OT,EXP)
    9    (20080714,20080405,42F,10,FRANCE,HO,6639697)(MD,EXP)
    8    (20080711,20080101,65M,3,US,HO,6668712)(MD,EXP)
    7    (20080812,20080301,37M,17,SWEEDEN,HO/DS,6723013)(MD,EXP)
    6    (20080904,?,?,?US,OT,6759796)(MD,EXP)
    5    (20080916,20080801,27M,3,US,HO,6775301)(MD,EXP)
    4    (20080926,20080911,47M,22,US,HO,6781760)(MD,EXP)

    2Q08    second quarter 2008
    3    (20080602,20080201,58F,6,CANADA,HO,6592631)(?,EXP)

    1Q08    first quarter 2008
    2    (20080221,?,?M,10,US,HO,6394492)(?,EXP)
    1    (20080318,20080304,49F,10,US,HO/DE,6601236)(MD,EXP)

    4Q07    fourth quarter 2007
    None    

    3Q07    third quarter 2007
    None    
    2Q07    second quarter 2007
    None    
    1Q07    first quarter 2007
    None    
    4Q06    fourth quarter 2006
    None    
    3Q06    third quarter 2006
    None

 

 ------------------------------------------------------------------------------------------------------------------------------------

   BIOGEN REPORTS OF CONFIRMED PML: 

 

    2009 FOURTH QUARTER & BEYOND

    Biogen no longer reports confirmed cases.

 

    2009 THIRD QUARTER
    Biogen:   
    "7/24/2009-29doses,US(unknown age or gender,Alive)"   
        "Biogen stopped reporting on July 24,2009."
    http://pietynorwit.com/Tytable.htm   
       
    2009 SECOND QUARTER       
    Biogen:   
    "4/15/2009-31 months,Ex-US(43F,E.U,Alive on Ventilator)"   
    "5/18/2009-24 doses,US(35F,alert/walking problems & language problems)"   
    "6/10/2009-35 doses,Ex-US(45F,EU,Alive at Home)"       
    "6/19/2009-34doses,Ex-US(35F,EU,Alive)"       
    http://pietynorwit.com/Tytable.htm       
           
    2009 FIRST QUARTER            
    Biogen:       
    "2/5/2009 -12 months, EX-US(42F,Germany,Hospitalization(Alive & out of hospital))"       
    http://pietynorwit.com/Tytable.htm       
    http://www.medscape.com/viewarticle/585770       

    2008 FOURTH QUARTER                             
    Biogen:                       
    "10/29/08-14 doses, US(59F,Death)"                       
    "12/10/08 -26months, EX-US(57M,Germany,Alive/Communicative/ Improving)"                       
    http://pietynorwit.com/Tytable.htm                       

    2008 THIRD QUARTER                                                                       
    Biogen:                           
    "7/30/08 - 17months,Ex-US(37M,Sweden,Aive in Rehab/Stabilized)"                           
    "7/31/08 - 14months, EX-US(52M,Germany,bedridden at home)"                           
    http://pietynorwit.com/Tytable.htm                           
                               
    2008 SECOND QUARTER                                                      
    Biogen:     not reporting on their website at this time.                       

    2008 FIRST QUARTER                                                      
    Biogen:     not reporting on their website at this time.                       

    2007 FOURTH QUARTER                                                      
    Biogen:    not reporting on their website at this time.                       

    2007 THIRD QUARTER                                                     
    Biogen:    not reporting on their website at this time.                   
                           
    2007 SECOND QUARTER                                               
    Biogen:    not reporting on their website at this time.   

 

    2007 FIRST QUARTER                                               
    Biogen:    not reporting on their website at this time.  

 

    2006 FOURTH QUARTER                                               
    Biogen:    not reporting on their website at this time.  

 

   2006 THIRD QUARTER                                               
    Biogen:    not reporting on their website at this time.