The Eltroxin controversy: GlaxoSmithKline responds

The head of medical affairs at GlaxoSmithKline New Zealand, Andrew Hvizdos, has responded to questions from NBR regarding reported severe reactions to a reformulated version of a potentially lifesaving drug they produce - Eltroxin.

Can you tell us how many people to date have had an adverse reaction?
Medsafe has recently stated that around 600 events have been reported. The majority of the 70,000 patients in NZ have transferred to the new formulations successfully. Patient safety with our medicines is our first priority at GSK so we share the frustration of some patients in NZ of feeling unwell when extensive testing and retesting by GSK has shown that the tablets should be safe and effective when used as prescribed.

Have there been adverse reactions in any other markets the drug is sold?
We have seen a very small increase in adverse event reports in a small proportion of the other markets receiving the new formulation and no increase in the others. We have not seen the same trend anywhere else as in New Zealand.

Why the reformulation?
GSK has consolidated the manufacturing locations for Eltroxin tablets. Changes in formulation are fairly common as the technology used to produce a medicine evolves and GSK’s manufacturing processes evolve to reflect this. Eltroxin requires a specialised manufacturing process and GSK is reviewing its manufacturing locations in light of this.

Apparently animals given the drug are also exhibiting adverse reactions?
Eltroxin is not registered for use in animals so we are unable to provide any guidance in this area. We suggest owners speak to their vet about any concerns.

What procedures are under way to determine the cause of these reactions?
We are concerned that some patients have been experiencing symptoms which are difficult to explain but causing them to worry. It is important that patients with any concern about their medication should make an appointment with their doctor as soon as possible to investigate the cause of the symptoms.

An increase in adverse event reports is not uncommon when patients are placed on a new or reformulated product. It is important to establish whether an adverse event report is related to the medicine itself or to other factors such as dosing or interaction with other medications.

The challenge in interpreting the adverse event reports received from patients is that:

Symptoms may relate to other causes such as incorrect dosing, interaction with other medications taken by a patient and symptoms from a thyroid disorder itself or other health issues a patient may have.

An increase in public awareness often leads to an increase in reports so it is important to establish if the report is specifically related to the patient’s medicine or if the concern raised by public awareness has caused patients to attribute existing, unrelated symptoms to their medication.

A small number of patients will be unable to tolerate any given medication. Usually those patients would be prescribed an alternative treatment. No alternative is presently available in NZ but we understand Pharmac is actively looking for a new supplier.

Whenever someone’s thyroid medicine is changed, it is important that they are closely monitored by their doctor to be sure there is no change in their condition. If they are experiencing symptoms, it will be important that their doctor repeats their thyroid function blood tests to determine if their levels have changed and their dosage needs to be adjusted. Any change in dosage could take up to 6 weeks to see the full effect of the change.

For more information on how thyroid patients should be monitored following any change to their thyroid medicine, including information on the Eltroxin tablet changes, please go here.

GSK is determined to get to the bottom of this issue and is working with Medsafe to decide the best course of action.

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26 Comments & Questions

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There are a large number of thyroid people on Eltroxin including children and a large number of elderly in rest homes, most are not in a capable of filing reports even via their doctors who are brushing of all the side effects as being in their head. A number of people who have suffered these symptoms are taking up a number of hospital and doctor appointments some using their own private health care spending or public costs, for negative results on test that have been carried out. One hospital Wanganui DHB reported an increase in elderly filling up there A&E. would be interesting to see how many were on thyroid medication. That’s an additional 70,000 people using health care services that is not needed, sure the NZ health system
can use the additional services for people that are not on Eltroxin. I myself have spent money on dr visits to be told there is nothing wrong, glasses that were not needed.

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Eltroxin Update - Wednesday, 10 September 2008
10/09/2008 CARM has received 855 reports. One would think that he would have upto date information.

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i have been on Eltroxin for 3 months and I have noticed the difference from my other medicine. I have had hair loss, experinced confusion, forgetfulness, blurry vision, itchy eyes. My Doctor never told me that my medication had changed.

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I am in exactly the same boat have been on thyroxin for the last two years and started having hair loss, eye problems, confusion, tiredness and weight gain about 6 months ago- I had no idea the formulation was changed so I kept on thinking there is somethign wrong with me!

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I have changed from eltroxin to Whole Thyroid tablets at a cost of $75.oo for 3 mths supply. Have had blood tests & my thyroid is still out of kilter, Had no trouble with the old thyroid drug, but when started on Eltroxin had nausea,headaches,palpatations,& panic attacks,these feelings are like depression but I know its the thyroid medication. Was told by several chemists it was all in my mind. damm disgusting of them.

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I have been on Eltroxin for several months and have had no adverse reaction whatsoever.

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I have recently emigrated and had a supply of thyroxin with me from the UK. I have been on the NZ formula for 3 months and I am suffering side effects. It is like when I was first diagnosed. Week by week I have got worse. I am appalled that I was not informed by the medical profession that the drug was manufactured differently here and to be vigilant against any side effects.
Finally this week I asked the pharmacist if the drug was the same as in the UK. I was told no, and to visit the GP.

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Since June 2005, when I was put on thyroxine, my quality of life has been appalling. Every 5 or 6 weeks I was at my doctor complaining of palpitations, tingling of mouth and fingers,wavy lines in my eyes, hair loss,insomnia,panic attacks,pains in head and generally very miserable. I was elated when this all came out as I was starting to believe I was a hypochrondriac as all visits to endocrinologist, neurologist,cardiologist plus countless scans, showed nothing. I never in the past three and a quarter years, since I was put on thyroxine, experienced a "well" day. As I am on pills for high blood pressure, my doctor was sure that these were the problem, so I had various attempts on different pills, so I would feel well!! I am now on atacand and have weaned off the thyroxine. In three weeks I am to have blood tests to see how I'm doing with no thyroid pills. Already I feel so much better. I resent having the enjoyment of the past three years taken from me and would be happy to stand up and be counted. I don't care when "they" say the altered drug was available, as I am proof that in June 2005, the poison pill was being prescribed.

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I am 38 years old and have a tyroid problem and require medication to keep it under control. My doctor prescribed Tyroxin and then change me to Eltroxin not sure how long i've been on it. I have several of the above mentioned problems, Im putting my weight without over eating, suffering from continual migranes, and have been depressed for many months. My husband has noticed the change in my moods. What can i do, should stop taking the medication. Cheers Anna { Lower Hutt New Zealand.}

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I to have had ongoing health problems since the change over to the dud thyroxine in January 08.I have had severe lethargy, increase in migraines, dizziness, nausea, weight loss, no apetite, depressed, sore legs, back and hips, light headedness. I have seen the Dr, endocrinologist had scans and blood test and all is normal.I have finally changed over to the goldsheild levothyroxine a week ago and I am already starting to have a little more energy, lets hope it continues.

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No one can force you to take medication (NZ Bill of Rights Act 1990, section 11) so if you're having side effects, tell your doctor to change your medication!

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I developed polymyalgia last year at about the same time of the change to Eltroxin. Since then I have put on weight, been greatly fatigued, had blurry vision, palpitations, numbness in fingers, pain in my arms and lower back, and very swollen lower legs and ankles. The old thyroxine suite me and I had none of these problems when taking it. Seeing that I was unaware of a change of tablet until weeks after the release in the newspapers, and I do not take any other medication, it cannot be the result of interference with other drugs or psychosomatic. I would be interested to know the extent of the 'repeated testing' that GSK carried out. The total of 1200 complaints to CARM so far is, I am sure, just the tip of the iceberg. I am now taking Whole Thyroid Compound and am beginning to feel improvement but it is a slow process. No more synthetic drugs for me after this experience if I can possibly help it. I wonder if GSK is starting to notice a drop in sales yet?

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I have been on eltroxin for the past six months and feel as if I haven't slept for six months right after i get out of bed. and my the soles of my feet are so dry and cracked I cant were sandals from embarrassment.

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hello,Debbie,i' m dominique thibault from paris in paris.I' m looking for a Debbie Waite i met in France a long time ago.I wish you're allright now.My email:dtibolive@hotmail.fr.

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hello,Debbie,i' m dominique thibault from paris in paris.I' m looking for a Debbie Waite i met in France a long time ago.I wish you're allright now.My email:dtibolive@hotmail.fr.

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2 months ago I had another bad experience of fainting..I had been taking co-enzyme Q10 as a supplement. I stopped this immediately as when I searched the net I found that this supplement can interfere with thyroid drugs... I also changed to Synthroid. It took me a couple of weeks to lose fluctuations in Blood Pressure but I remember the first morning I woke feeling like I had had a wonderful nights sleep (like camping). I also have my 'brain' back. I have to pay $1 per day for the pills. I had been waiting for goldshield but felt I couldn't wait any longer. Anyone else had my experience?

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I have been on eltroxin for the past 8 or 9 years. I never had a complain. I have changed my docs a couple of times, but every1 prescribed eltroxin, so I don't really know whether diff drugs other than eltroxin cud have been even better for me. In general, I've noticed reduction in brain fog, lethargy and so on. But, yet I have had terrible hair loss eversince i started takin eltroxin. Other problems are shortness of breath, dry skin, weight gain (prior to thyroid diagnosis, I didn't have this weight issue, which strikes me as very odd!). However I'ld like to switch on2 diff drugs preferably with diff doses, just to see if they are any better.

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I AN USEING ELTROXIN PAST TWO YEARS SINCE FOUR MONTHS IN MY HANDS DARK SKIN SEEN SOME TIME IS LIGHTER SOME TIME DARK PL ADVICE .

REGARDS

NARAHARI

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After six months off GSK I am still trying to get back to a state of health prior to the new formulation change.I have lost all faith in synthetic drug manufacturers and pharmaceutical companies and recently changed onto Whole Thyroid Extract..I am begining to feel like a human being again....hoooray for WTE..T4 keeps you alive and WTE gives you your life back.:-)

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I have been on eltroxin(Jan. 09 to May 09), my first regular drug, since vioxx in 2000!! I guess I made another mistake--I immediately gained 8 pounds (2weeks into taking the drug). My energy is low and most worrying I think I have heart palpitations and my doctor still wanted to increase my drug from 50 to 75!! I will be coming off of it asap!!

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Well after reading all those comments i too am having troubles with Eltroxin , sweats , dry reaching , and dysentry , and generally feeling sick life is miserable . My doctor is sending me for tests for my bowels which im sure will all come back fine will wait and see come on more people out there please comment on your medication we need to get this sorted its not a joke anymore .

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I know many people who were told that its only in their "head". And they were even sent to Psychiatrists. With symptoms like dizziness, weight gain, heart palpitations and much more symptoms from changing the Eltroxin without informing them.
but, hey people, what do you expect? Business is business and if this new Eltroxin brings more money, so why should they care about the fact that they ruin other peoples life??

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I have been on thyroxine for many years. Since the beginning of this year, i had been having itchy rashes on my neck. No cream seemed to work. My doctor prescribed hydocortisone which worked well when the cream is applied but the itch returns when I stopped . Now I have noticed that the skin on my neck had become darker and there are ugly rashes on my neck.My neck is getting extremely itchy and I lose sleep because of the itchiness, Can anyone tell how much it cost to buy other brands of throxine and if they are any good.

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I have been on eltroxin for 4 years now (now on 0.15MG) and am tired and forgetful- I feel like I am 68 not 38. I have always been an incredibly energetic individual, but that is gone. I am convinced it is the Eltroxin as each time my dosage is increased I feel worse, rather than better. My endocrynologist tells me there are no side effects to eltroxin. What can I do? I have 3 children and I can't carry on with this lack of energy but am scared to stop taking it. Help.

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I been on eltroxin foe many years and I have the same problems has you also my hair is falling out.

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I have been using eltroxin for 25 years o.1mg and have been well on it except the last two years have had back pain sleepless nights and gained more weight, did not associate this with change of ingredients, my test a week ago showed I needed increase dosage but eltroxin does not come in 0.125 mg so switched me to another brand......also with side effects of course. I was upset because I had felt well for most of those years on eltroxin but now reading your comments may explain my last few years of misery. we will have to see what this new synthroid does, at 78 I guess I can expect some aches and pains

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