Thalassemia Patients and Friends
Discussion Forums => Iron Chelation Corner => Topic started by: elturkait on September 12, 2007, 08:52:05 PM
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Hi all,
This is my first massege at all, I would like to introduce my self, my name is emad from State of Kuwait. and I am 37 years old Thal. Major Patient.
could anyone give me more details about the side effects of Exjade? and is it suitable with older age patients?
thank you.
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Hello Emad,
:welcome to the site! Feel free to ask more question that you have in mind and do tell us more about yourself.
Exjade is mostly recommended for patients above 6 years of age.
Most of the patients don't suffer from serious side effects. Some patients may experience temporary rash or upset stomach problem, but that goes away with time by lowering the dose and then eventually bringing it up back slowly.
However your serum creatinine should be monitored regularly with the use of Exjade and it should be stopped if the level increases with time. Similarly patients with renal problems should avoid it or use it with their doctor's advice and supervision.
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Hi,
Welcome,i am on exjade and so far have only had a few minor side effects.I have had diahorrea
(sorry to go into detail!) and that was only after taking it for 3 weeks in the beginning,but it was only for a couple of days then went away.I also had minor headache which sometimes comes & goes but is handleable.I think if you can put up with this few minor side effects it beats having painfull needles each night.I know though another side effect is a skin rash (which i didnt have) so other patients on here maybe able to shed some more info for you.Good Luck with the exjade,keep up updated on your progress.
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Hey elturkait,
Since its relatively new on the market, i am not sure if anyone can truly say what the side effects are. I guess that it will be a learning experience for all of us based on the feedback seen here. Some of my friends using it have said that they ferritin levels have actually gone up so far, but I guess that its early days yet.
good luck though
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Hello Emad,
Welcome to the forum,I don't know much about Exjade, as my daughter is on a combination therapy of Desferal and Ferriprox (L1).Do tell us more about yourself,I hope you would find this forum very helpful.
ZAINI.
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Hi everybody,
Actually, i send my 1st massege before start the exjade treatment, and with this 2nd massage i am already on exjade Low dose :spit (2 tablet /1000 mg daily/ and my weight is 57 Kg) with non-use a desferoxamine (Desferal) for 2 weeks till now.
My ferritine level was 927 before started treatment, but i dont know what happend with it after next few weeks. ???
my total health situation is very good, but i am woried about the next step when my Doctor start to increase my dose (it could be 1500 mg daily).
but i have one question i need the answer for it, ...iron chelation.
which is more effect ? , desferal or exjade?
Thanks for all,
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Hi Elturkait!
WELCOME! hope you find all your questions, answered. To answer your question which is more effective i think they both are working great, same effect and same intensity, but so far desferal has few side effects than the exjade, in my own opinion, i've been using desferal since I was just a child and so far the only side effect i can tell it's painful from the needle and from the bump you will have after the pump has been removed. now that i have turned 30 i'm using combination therapy with desferal and exjade, and like Sydney said i have been experiencing the same things as she had, and just realizing that these are brought about taking exjade....... but i think this is just minor rather than the effects of not having chelation at all........ especially now that i'm having problems again with my liver......by the way i'm just taking 500 mg of exjade every other day...
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Hi Lyanne,
Your comment is news to me as i had heard previously that the exjade had to be used by itself and should not be combined with any other chelator. the only two allowed for combination (done in the UK with good results) is desferal and ferriprox.
Has anyone else been told this? :(
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حياك الله welcome to your seconde familly
Dear Emad am a father of a child who was thalassemia major and i did for him an BMT..I am also from state of kuwait and still treat my son in SABAH HOSPITAL .
I have a good news for you and all the thalassimic PpL in state of kuwait ,, Professor Lucaralli he will visite Kuwait in 24th november i don't know how long he will stay in kuwait but am going to take my son and my doughter to meet him in the airport i wish i see you to talk more and also you can ask Dr Hisham in Sabah hospital (NBK) a bout the Exjade ..
PS: MY PHONE NUMBER 9026225
khalifa
state of kuwait
one for all and all for one
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Good to have you with us! I have been on Exjade since last January. My ferritin levels had not changed much from what they were on Desferal. but I have only been on 1000 mg. of Exjade all this time. I was finally put up to 1500 mg. just recently, and my ferritin level has dropped to 2300, lower than it has been in 3 years. I also started using a plastic spoon to stir it.
Exjade is good for older people - I am 56. I had a little difficulty getting used to it at first, but I am fine with it now. I just felt like my whole body was down, and like I had the flu. I was nauseated. That eventually went away, and I don't really feel any side effects now. When I recently added the third pill, I started to feel the side effects again, so I went back to 2 pills until I had a transfusion, and just generally felt better. Then I added the third pill again, and I haven't had any trouble. I am really excited to get my ferritin level down lower.
It's good to meet you. Good luck with Exjade, and I hope things go well for you. Jean
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Hi B thal girl,
No one told me that it should be combined with desferal, why is this bad? is there any bad side effect when you take exjade while still using desferal? i'm worried..... ??? :scared, but my hema did prescribed 3x a week of exjade and 2x a week of desferal....
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To Lyanne,
In regards to your question about using desferal & exjade togther,there has not
been enough study to see what effects it has using both togther,but i know
Danielle (and you can ask her) takes both togther,but most doctors are against this.
so i have been taking exjade on its own and so far exjade has worked for me.
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To Lyanne,
Sorry if i scared you but from all the forums/ information seen so far it seems that exjade should be taken on its on. I am on combination but with ferriprox. Maybe its okay for you but I just wanted to know if things had changed and they didnt publish it.
so maybe andy or danielle can help?
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Hi welcome to the forum I'm from kuwait ow saba7 hospital too and yes i highly recomend that u talk to DR.Hisham about exjade :)
and actually im still suffering from side effects of exjade like fever and vometing :S
I've been on it for 4 months now :)
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Hi! B thal girl and sydneygirl,
Sorry for the late reply I was hospitalized due to infection which leads to lowering my hg and I was needed to be blood transfused again, 2 units and stayed in the hospital for antibiotic treatment. Anyway I'm doing great again tho i'm still under medication.I wanna thank you guys for anwering my question i just got shocked upon knowing the info, anyway is it really that bad taking exjade and desferal at same time?what if i use it alternately (this week exjade, next week desferal)
is it still not a good idea? :dunno
Ei......... Andy what are your thoughts on this?????????????
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Hi Lyanne,
I am so sorry to hear about your sickness, i hope you are doing fine now, i believe that Danielle was using exjade along with desferal,you can ask her about that,i hope she is doing fine.
ZAINI.
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The combination of exjade with desferal is being studied by Dr Vichinsky but no information is yet available. The official position of Novartis is that since no studies have been concluded on the combination use of the two drugs, that they should not be used together. Of course, Novartis has no choice but to say this in order to protect themselves from possible lawsuits.
We do have several reports from patients who have used both drugs together and have had success in quickly lowering ferritin levels from dangerously high levels. Some doctors in the US are prescribing the combination. As always, the patients are the guinea pigs for this research. I would suggest that anyone deciding to try this combination, begin with low doses of exjade and see if the combination is tolerated before using higher doses. This decision has to be made by the patient and his/her doctor.
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Dear Lyanne :hugfriend :hugfriend
Very sad to know about your sickness, hope you have full recovery. Take care and eat well
Manal
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Thanx Zaini and Manal, I'll be fine soon. Andy, thanx for clearing that up for me. Well, hope i'm one of those patients who are sucessful in using both drugs and does not have any side effects. and thanx guys!!!!!!!! :hugfriend :wink
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Hi Lyanne,
I hope that you are feeling better now.
Get well soon :getwell
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Thanx Sajid! :hugfriend :grin i'm feeling better now, hopefully i'd be okk soon...........
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Hi Lyanne,
Great to know that you're better now.
B thal Girl
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I'm so glad you are doing better now, Lyanne! :hugfriend
Yes, I was one of the patients using combination therapy of both Desferal and Exjade, and I was fine as far as combining the two. The only problems I had were due to the Exjade on its own (severe rash and diarrhea), which eventually subsided. I'm only on Desferal right now, though, because the recent surgery that I had required me to stay off of the Exjade. I will be starting the Exjade again soon, though. :)
As Andy had said, we are the guinea pigs, as usual. There just hasn't been enough study for Novartis to give its blessing on combining the two chelators. They're just trying to dodge a lawsuit. :rotfl
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Just saw this online and wanted to share it.
EXJADE Reports of Liver Failure, Deaths Lead to Label Changes
Date Published: Tuesday, March 11th, 2008
EXJADE has been linked to liver failure and deaths in some patients, prompting its manufacturer to add new warnings to its label.
EXJADE, which is known generically as deferasirox, is made by Novartis and is used in the treatment of chronic iron overload caused by blood transfusions for the treatment of anemias for adults, adolescents, and children aged six years and over. EXJADE is also used in children aged two to five years who cannot be adequately treated with deferoxamine.
It is recommended that therapy with EXJADE be initiated and maintained by physicians who are experienced in the treatment of chronic iron overload due to blood transfusions. Recently, cases of severe liver problems— including some with fatal outcomes—have been reported internationally following the post-marketing use or commercial use of EXJADE. Most cases involved patients who suffered from multiple medical conditions, including liver disease (cirrhosis) and multi-organ failure. When taking EXJADE, liver function should be monitored monthly. EXJADE treatment should be ceased if there is any unexplained, persistent, and progressive worsening of liver function.d start EXJADE therapy. A serum ferritin level is a marker of iron level in the blood. The EXJADE use was stopped and the patient recovered. Based on the information available, the potential role of EXJADE cannot be excluded as having a link to the adverse reactions, however, after reviewing this case, Novartis and external medical experts agree that there are extenuating circumstances around this case.
Recently, a report of severe liver problems with altered brain function—encephalopathy—have been reported to the Food and Drug Administration (FDA) in the Unites States in a patient who had taken EXJADE for five days. The patient’s hospital records indicated that the patient also had a history of alcohol use and had slightly abnormal liver function prior to using EXJADE. Also, the patient was treated for a non-approved use of the drug while also having a serum ferritin level that was more than 10 times lower than the level recommended to start EXJADE therapy. A serum ferritin level is a marker of iron level in the blood. The EXJADE use was stopped and the patient recovered. Based on the information available, the potential role of EXJADE cannot be excluded as having a link to the adverse reactions, however, after reviewing this case, Novartis and external medical experts agree that there are extenuating circumstances around this case.
Since October 31, 2007, there have been a total of 36,797 patients treated with EXJADE: 31,444 since its approval and 5,353 who were treated in clinical studies, pre-marketing. Of these patients, there have been a total of 24 international reports of liver failure. Of these international liver failure reports, 21 cases occurred post-marketing and three occurred during clinical studies. Patients in Canada reported two of the 24 reports of liver failure. No patient with normal liver function or without additional life-threatening complications of their underlying disease has developed liver failure.
EXJADE has not been studied in patients with liver problems and must be used with caution in patients with severe liver problems. If you have any questions about the relationship between EXJADE and recent reports of liver problems or about EXJADE in general, please talk to your doctor or pharmacist or contact Novartis Pharmaceuticals Canada Inc. at: 1-800-363-8883.
Although a clear relationship between EXJADE and severe liver problems has not been established, the Consumer Information for EXJADE has been updated to include this important safety information related to current findings linked to liver complications. For more information on EXJADE, the Consumer Information document can be located at: www.novartis.ca.
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B Thal Girl,
The liver problems for exjade users have been reported as stated above. In majority of patients the problem was pre-existing and worsened by the use of Exjade. A standard protocol before starting exjade is to check liver function through blood test and weekly test after starting exjade for three months. Once it is established that exjade is not interfering with liver function, the frequency of blood test can be reduced to monthly.
My daughter is using exjade for almost 50 days now and we have only experienced anxiety as a side effect but she is getting better.
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Dear B Thal Girl,
May I know where is this article from?
Thanks.
Nur
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This warning was issued in Canada. Once again, Novartis is delinquent in publicizing this warning. They took their time with the warning about kidney failure and once again, and only "Following discussions with Health Canada, Novartis..." has acted. I could not find any new information about this on their site. This is crucial information, and patients using Exjade without proper supervision should pay very close attention. Liver ALT tests and creatinine tests must be done on a regular basis.
My biggest fear with Exjade is the same as with L1. Many patients will take these drugs without proper supervision and run the risk of serious side effects. Please do not use either drug unless you are under the care of a doctor familiar with iron overload. Anyone using Exjade should make sure their doctors are aware of these findings. Don't wait for Novartis to inform them.
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2008/exjade_2_hpc-cps-eng.php
March 7, 2008
Subject: Reports of severe liver problems with EXJADE* (deferasirox)
Following discussions with Health Canada, Novartis wishes to provide you with updated safety information regarding reports of severe liver problems with EXJADE*...
* Cases of hepatic failure (some with a fatal outcome) have been reported internationally following post-marketing use of EXJADE*. Most of these cases involved patients with significant comorbidities including liver cirrhosis and multi-organ failure.
* As indicated in the currently approved EXJADE* Product Monograph, it is recommended that liver function tests be monitored monthly. If there is an unexplained, persistent and progressive increase in serum transaminase levels, EXJADE* treatment should be interrupted.
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Great! :rolleyes
My PLTs and WBCs stay low so I can't use L1.
My ALT stays high (178 currently) and now I know I won't be able to take Exjade when it is on the verge of our reach in Pakistan. :frustrated
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EXJADE has been linked to liver failure and deaths in some patients
WHAT? :faint2
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Dear B Thal Girl,
May I know where is this article from?
Thanks.
Hi Nur,
Andy gave you one website but I actually got it off a newspaper report.
canadian family,
I am a patient just like most people on this site. i also experience fear when hearing about the various side effects of the drugs. I have found though that the reporting is a bit one sided at times and the "horrors" of one drug is always highlighted while the "true stuff happening" is hidden.
Every thing printed though always help to make sure that we are aware of what we should be monitoring ourselves, as in my case i know that I must be monitored regularly to ensure that my neutrophil counts remain over a certain level. Just because a particular drug is working for me does not mean that I would close my eyes to its side effects. I try to do ALL my testing an a timed basis to ensure that i remain healthy.
We are each others keepers so if something comes up we should let everyone know, we cannot wait on the drug company to come forward as we know that it may never happen.
Sajid,
My counts go up and down at times as well, the important thing is the monitoring. I know that you are strong and will continue to be so keep focusing on things and they will go the correct way.
So please lets continue to support one another. We are all one big family!
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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).
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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.
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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?
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Ah! No worries B thal girl. You can ask any question anytime and seek information.
:hugfriend
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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?
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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.
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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.
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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.
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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.......
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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!
:hiyagirl Sharmin
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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 :hugfriend
Manal
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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.
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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.
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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. :hugfriend :hugfriend