Side effects (ExJade)

Indeed these oral chelators are going to be lifesavers for the younger generations as they have the pre requisite criteria ( less/no liver fibrosis and normal spleen) and have normal blood counts for WBCs/PLTs/ALT/LFT etc.

I'm just a bit concerned with old timers like me where the damage has already been done and using these oral chelators could be a bit too risky (according to what's been unfolding with L1 and Exjade).

Just to clarify, my daughter is taking exjade under strict doctor's supervison and is monitored each week religiuosly.

On the side effect of liver problem, the topic has been discussed so many times on this forum and is well known to exjade users and among forum members.

Its fantastic when we are lucky enough to have dedicated doctors and proper monitoring. we must be especially grateful for that. Some of us are not that lucky and depend a great deal on the experiences and information of others together with that from forums like these.I have also been extremely fortunate myself to have my parents support and supervision throughout my life.

Canadian Family I never meant to cause any additional worry but the articles and information was new to ME and I felt that there would also be those out there who did not know of it and are not monitored as they should be.  You must know that one of the biggest problems we thalassaemics face is the shortage and fast turnover of doctors dedicated to our care.

We are all in this together aren't we?

Ah! No worries B thal girl. You can ask any question anytime and seek information.

 

Canadian family,
Thanks a bunch. I guess that i am a bit sore on the subject as well as I have been having real problems since coming to Canada. I am being expected to accept lower pre HB levels than I am accustomed to- which causes me to really struggle through most of the last week, I cannot get any medication- it seems that no one has the nerve to really stand up for the patients here in Canada- even though they know that things are working fine everywhere else!!!! I have had to trek back to the UK for my supply of medication. Its 2008, and we are all human beings- i have proof that i have been improving since I was put on the combination therapy but NO ONE is interested in going forward with this. Afetr five months here you wont expect me to be patient now would you.

Other than my problems, we are extremely happy here but if its not sorted out soon, I am going to be the cause-yet again- of uprooting my family and moving....is that fair?

I know that it is just not one person but its collective- who should I go to? I have also been sent private messages from other canadians on how to get the combination therapy- which i know is commanding the best results internationally-, can you help?

I am running out of options and tired of being a rolling stone- being kicked around most days.
So if anyone can help?

This depends on so many factors. From what I understand every country has adopted their own standard of care, what you might experienced in UK may not be valid in Canada.

There are factors such as your status in Canada (if you permanent resident or citizen than you have access to medical facility free of charge, however, to my knowledge nobody would be turned away on humantarian basis).

I also found doctors here follow a strict line of action with respect to the management of thalassemia. e.g. they may not simply give you combined therapy just because you were getting it in UK. There has to be a established case that you need one and that can be determined by the doctors in Canada not in UK.

It depends which center you are going, I know TGH (Toronto General Hospital) has an established thalassemia clinic and they serve number of patients.

You mentioned you are currently not getting any medication, I don't understand what you mean. Every patient is entitled to have free desferal and supplies from the government. However, if you are not permanent resident or citizen then you have to buy desferal from your pocket. If you mean L1 than it is not approved in Canada. If you mean exjade than you have to buy it (not provided by the government).

You mentioned you are expected to have lower pre-hb levels, I don't understand this either. The standard of care is to have mean of 10g/dl hb for every thalassemia patient and is strictly adhered to. Was that mean high in UK?.

These are straight facts and I think part of adjusting in a new country and new medical system. I know it can be frustrating for you but I suggest be consistent and have faith.

I do agree that each country may have some systems which may be a bit different but i do feel that the international standards should be more or less in line. I do have access to medical care here but feel that the system should be a little easier to maneuver. For instance I am told that the standard acceptable pre transfusion level is 9g/dl. It is easy for a specialist to say this but it’s harder for someone who was advised to try and stay above 10g/dl. Actually sometimes I wish that they could get about 1 day walking in our shoes to understand the way we feel at times.

Ferriprox is not approved here- the question is why? It has been approved everywhere else (except USA) with amazing results. Exjade is available and is being offered but its not MY choice. Why should a drug which is quite recent be so readily available, when others being used for over 20 years not be available?

How long is it going to take for me to get access to it? Why can’t someone get up and say enough is enough lets knock down the obstructions and get a straight standard for everyone. We have an international body who are supposed to be there for us, why is it that this is not even being queried?

I have not even been able to get the desferal as I am not actually been treated at TGH, and my specialist is still "writing" to get me a prescription for the desferal at least. So my story continues. If we could not afford it up to now, then what would have been my case?

I remember being at an international conference in Cyprus some years ago, and while I was very young then …the country that stood out for me was Canada. I cannot believe that I could have been so wrong.

Maybe I am the only person feeling this way but I was brought up to always stand up for what I believe in.

It is a shame and a crime that L1 is not readily available to patients in the US and Canada. The reasons why have been stated in my prior post at http://www.thalassemiapatientsandfriends.com/index.php?topic=1317.msg10624#msg10624

Dr Olivieri has been portrayed as a martyr and a hero and in my opinion she is neither when it comes to this topic. She is a fine thalassemia doctor but her blind stubbornness may have cost patients their lives. Every study ever done about L1, other than her own questionable study, has shown that it works and is safe when patients are properly monitored. Olivieri's refusal to admit she was wrong has helped deprive thals of a much needed chelator.

L1 should be approved. There is no other iron chelator that removes iron from the heart as well as L1. Heart failure is the number one killer of thals. This is a no-brainer. Withholding this medicine is downright criminal!


I would also like to clear up some misconceptions about the Exjade report. This is a new report that was only just released on March 7, 2008. The 24 cases of liver failure due to Exjade use have not previously been reported. The report and new recommendations that were released in January of 2007 concerned kidney failure in Exjade users, not liver failure, The only prior reports of liver failure concerned patients over the age of 55. This new information has only been released in Canada and only after prompting by the Canadian authorities. This information is crucial to patients who have liver disease (hepatitis for example). Whereas this information won't mean any changes for patients with healthy livers, it does mean much for older patients who need to be informed, along with their doctors that Exjade can lead to liver failure when the liver is already sick or damaged. Any changes in liver levels must be noted and with any significant change, Exjade must be interrupted.

This new information is significant for older patients who may have liver problems. There has been nothing in this information or the prior information about kidney failure, that should worry patients who are in good health. No patient without liver problems has had any recorded incidents of liver failure from Exjade.

Novartis does recognize that the 24 cases are probably not all that have occurred and they do request that doctors and patients report ALL adverse reactions (not things like the rash, unless severe).

http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2008/exjade_2_hpc-cps-eng.php

Managing marketed health product-related adverse reactions depends on health care professionals and consumers reporting them, in addition to reports collected from clinical trials. Reporting rates determined on the basis of spontaneously reported post-marketing adverse reactions are generally presumed to underestimate the risks associated with health products. If you have had a serious or unexpected reaction to EXJADE* you may notify either Novartis Pharmaceuticals Canada Inc. or Health Canada as follows:

Novartis Pharmaceuticals Canada Inc.
385 Bouchard Blvd.
Dorval, (QC) H9S 1A9
Phone: 1-800-363-8883

Any suspected adverse incident can also be reported to:
Canada Vigilance Program
Marketed Health Products Directorate
HEALTH CANADA
Address Locator: 0701C
Ottawa, Ontario, K1A 0K9
Tel: 613-957-0337 or Fax: 613-957-0335
To report an Adverse Reaction, consumers and health professionals may call toll free:
Tel: 866 234-2345
Fax: 866 678-6789
CanadaVigilance@hc-sc.gc.ca

The AR Reporting Form and the AR Guidelines can be found on the Health Canada web site or in The Canadian Compendium of Pharmaceuticals and Specialties.

For other inquiries related to this communication, please contact Health Canada at:
Bureau of Metabolism, Oncology and Reproductive Sciences
Therapeutic Products Directorate
E-mail: BMORS_Enquiries@hc-sc.gc.ca
Tel: 613-941-3171
Fax: 613-941-1365

For media inquiries, please contact Silvie Letendre at (514) 633-7872.

Andy,
Thank you for your views. I honestly thought that the patients and their needs should be placed above everything else. i dont like feeling sorry for myslef but we deserve a little bit of special care as we have to go through so much, we miss school, miss some of the fun outdoors when we are too weak to go out. I have been really tired for the last week as my hb levels are pretty low, yet i am still expected to study and produce even better results than those who are there without a problem.

i really wish today that everyone can understand what it feels to be a thal, our feelings at times, having to drag our tired bodies off our beds and carry on. having to stick ourselves on previous site areas and be uncomfortable all night, only to have to repeat it the next day. Is it all worth it, do you think?

then we go to the hospital and meet a committed individual who tells us that ther is "no biggee" dealing with a lower than normal count. God grant me one wish.......

Happy to meet you emad!  I hope that you get answers to all of your questions here - as well as a lot of great friends!
  Sharmin

Dear  B Thal Girl

I can feel all what you are going through, i wish this can be solved really soon, please try to cheer up and know that we are all here for you

Manal

EXJADE Reports of Liver Failure, Deaths Lead to Label Changes
Date Published: Tuesday, March 11th, 2008   


regarding this info that was quoted,i knew after that before taking exjade a nurse gave me some info on exjade before taking it.But its a very low percentage and chance of this and people who have had liver failure had  previous problems.

also i noticed Lyanne you said in a previous answer back on page 1 could you take exjade 1 week and desferal the next rotating it,my doctor advised me that is not suitable to do- either one or the other.

Dear B Thal Gal,

We all have to pass through such phases, this is life,May GOD grant you strength,we are all here for you, our prayers are with you.

ZAINI.

Thanks guys,
I really needed that group hug today. Here is to hoping that your wishes all come through as it will be better for not only me but all others in this crazy part of the world.