What's Happening to Thyroid Patients Taking Eltroxin
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From: Rod on 8 Jun 2008 15:33 The other day I got a Google alert referring to a story in the (NZ) Southland Times . Now Mary Shomon has picked it up. Sounds very odd - and there appears still to be no explanation. Bizarre that GlaxoSmithKline are saying "Don't split the tablets" - the patient information leaflet for NZ says that they are available in 50 and 100 mcg doses - but then talks about 25 mcg dose changes. How can you sensibly achieve that without splitting? Bizarre that they are not stating the contents when the existing PIL gives the details for the old formulation. Bizarre that NZ have allowed the new formulation without making sure that the PIL has been updated. Any real ideas of what is going on? What's Happening to Thyroid Patients Taking Eltroxin Brand Levothyroxine in New Zealand? Saturday June 7, 2008 Folks in New Zealand are up in arms, because a reformulation of the drug Eltroxin (a brand name of levothyroxine manufactured by GlaxoSmithKline) appears to be causing problems in thyroid patients. Patients taking Eltroxin (which is government funded in New Zealand) are reporting all sorts of side effects and symptoms since the drug was recently reformulated. According to a company spokesperson, the reformulation was necessary due to changes in the manufacturing operation, moving the production of the Eltroxin from Canada to Germany. While GlaxoSmithKline is saying that levothyroxine in Eltroxin is the same, there are new filler and binders in the reformulated product. <http://thyroid.about.com/b/2008/06/07/whats-happening-to-thyroid-patients-taking-eltroxin-brand-levothyroxine-in-new-zealand.htm> Changes to thyroid drug formula blamed for sicknesses By SONIA GERKEN in Gore - The Southland Times | Monday, 09 June 2008 Changes to the base ingredients of a Government-funded drug prescribed for thyroid gland problems have been blamed for making people sick. A Gore woman, who has been taking the drug Eltroxin for more than 30 years, says she was just one of many who started suffering adverse side effects since the drug's manufacturer, GlaxoSmithKline, changed the formulation. Lyn blames the new tablets for causing her sore and itchy eyes, weight gain and depression. She feels much better since going off the new pills but stressed she was not advocating other people doing the same, Lyn said. Government funding agency Pharmac and the pharmaceutical giant yesterday acknowledged they were aware of people's concerns. Communications and corporate affairs manager Bernadette Basell said a medication reformulation often caused some concern because the tablets looked and maybe tasted different. Changes in the manufacturing operation had required the reformulation. She confirmed the manufacturing had moved from Canada to Germany but could not expand on the reasons why for commercial confidentiality reasons. MedSafe had approved the new formulation, Miss Basell said. Last month GlaxoSmithKline sent a letter to doctors and pharmacists to address "an increased number of Eltroxin related queries". The letter says the active ingredient in Eltroxin, known as thryoxine or levothyroxin, remained the same and in the same quantity. However, the base ingredients were different due to changes in the manufacturing process. The letter stressed that patients should take the drug on an empty stomach and not split the tablets. Miss Basell said if the company had any concerns it would be making changes, in consultation with MedSafe. A spokesman for Pharmac said it was MedSafe's job to address safety concerns and until that agency raised any issues Pharmac would continue to fund the drug. Gore pharmacist Mark La Hood said he was aware of three customers who were not getting the "same results" as when they were on the old formulation. Temuka pharmacist Allan Campbell was not as diplomatic and accused GlaxoSmithKline and Pharmac of trying to cover up a huge issue. He has six customers who have suffered adverse effects on the new formulation. To tell patients not to cut tablets in half and take the drug on an empty stomach was "just a jackup to try and allay criticism of the drug", he said. Lyn said she never clicked on to the cause of her health problems until hearing on talkback radio about other people's reaction to the drug. She put a call out for other sufferers to contact her and has had 25 people respond, she said. While not wanting to be alarmist, Lyn believed people should have been made aware of the changes to Eltroxin and the potential problems. "I'd like to get it (the drug) analysed to find out what's in it," she said. MedSafe did not respond yesterday. <http://www.stuff.co.nz/southlandtimes/4575143a6568.html> -- Rod Hypothyroidism is a seriously debilitating condition with an insidious onset. Although common it frequently goes undiagnosed. <www.thyromind.info> <www.thyroiduk.org> <www.altsupportthyroid.org>
From: Rod on 8 Jun 2008 15:35 Ooops - meant to include this comment from Mary Shomon's page linked on original post: Comments June 7, 2008 at 11:00 pm(1) Justine says: Is it just New zealand??? I take eltroxin and am having some serious eye problems that the hospitals cannot currently explain, they feel it maybe Thyroid related. I changed to 100mg 4 weeks ago and the box looks to be similar to the photo shown and is made in Germany.
From: john_glenn on 19 Jun 2008 01:44 On Jun 9, 7:35 am, Rod <polygo...(a)ntlworld.com> wrote: > Ooops - meant to include this comment from Mary Shomon's page linked on > original post: > > Comments > > June 7, 2008 at 11:00 pm(1) Justine says: > > Is it just New zealand??? I take eltroxin and am having some serious eye > problems that the hospitals cannot currently explain, they feel it maybe > Thyroid related. I changed to 100mg 4 weeks ago and the box looks to be > similar to the photo shown and is made in Germany. John here I have been having trouble with headaches, vision, mood changes etc. Had consulted my Dr who could not really give an answer to the conditions I am experiencing but prescribed I-Profen up to 6 per day for pain. Over this last week they have not had any effect in pain relief. I went back today to see the Dr and explained to him what I had seen written and heard via the internet about this Eltroxin and suggested to him that this could be what is causing the headaches etc. I asked if he had heard anything about this drug and side-effects being experienced by other patients of his. He was not aware of any problems associated with Eltroxin Tabs and there was noting in the lastest mail-out from MEDSAFE NZ. I then asked for him to write another script for thyroxin tabs to take to the pharmacy to be filled. There, I was told that there is NO substitute in New Zealand for Eltroxin and the problems being experienced by patients who have reacted to the new formular is a world wide problem. The pharmisist further went on to say, (a) you have to keep taking the current tabs as prescribed (3 x 50mcg per day), and (b) go back to your Dr to be refered to a specialist and (c) there is no alternative to Eltroxin. Will keep the group posted as to the results of the next visit. 19th June 2008
From: Rod on 19 Jun 2008 02:33 Mary Shomon has written a tiny bit on ABout: <http://thyroid.about.com/b/2008/06/17/thyroid-drug-eltroxin-in-new-zealand-still-causing-problems-patients-encouraged-to-make-reports.htm> And some further information coming to light - two articles popsted below: Woman blames drug for illness By NATALIE AKOORIE - Waikato Times | Wednesday, 18 June 2008 Zona Schlaadt took the drug Eltroxin for 36 years to manage an underactive thyroid, and had no problems. But three days after she began taking a new version of the Government-funded drug last month, the pensioner was rushed by ambulance to Waikato Hospital with vision and memory loss, blinding headaches, vomiting, diarrhoea, the shakes, and arthritic pain which almost crippled her. After she had brain, bone and stomach scans and three weeks in hospital, doctors could not determine what was wrong with Mrs Schlaadt except that her thyroid had tested overactive. Last week they sent the 76-year-old to Matariki Hospital, in Te Awamutu, where she is still recovering. "I believe my body has been poisoned," Mrs Schlaadt said. Her pharmacist, Dinsdale Pharmacy owner Brian Johnson, was so shocked by Mrs Schlaadt's side-effects he put a sign in the shop yesterday asking any users of the medication to alert staff if they have the same problems. Mrs Schlaadt, who now needs to use a walking frame, said her sister discovered a pharmacist, in the South Island, who had had six customers suffer similar symptoms after switching to the new drug. Pharmac medical director Dr Peter Moodie said he knew of concerns surrounding the drug but that the change had nothing to do with funding. Medsafe interim manager Dr Stewart Jessamine said Medsafe assessed the new formulation of Eltroxin as safe and effective and the new product was given ministerial consent in November, 2006. Since then Medsafe had had 27 reports of people suffering problems associated with the drug switch-over, "including difficulty in maintaining control of their underactive thyroid and reports of side-effects". Pharmacists and patients needed to bear in mind the revised formulation had a different dosing regime, he said. "This means that patients taking it should be monitored by a health professional and dose adjustments made, if necessary," Dr Jessamine said. "Patients should also make sure they are taking their medication on an empty stomach and are taking whole tablets in accordance with advice from their GP." In a letter to doctors last month, GlaxoSmithKline said the active ingredient in Eltroxin, known as thyroxin or levothyroxin, remained the same and in the same quantity. However, the base ingredients were different because of the change in manufacturing process. <http://www.stuff.co.nz/stuff/waikatotimes/4586972a6579.html> Eltroxin concerns highlight medicine issues Wednesday, 18 June 2008, 11:57 am Press Release: New Zealand National Party Jackie Blue MP National Party Associate Health Spokeswoman 18 June 2008 Eltroxin concerns highlight medicine issues News that patients are experiencing problems on Eltroxin, a sole supply thyroid medication, after its formulation was changed, is a case of déjà vu, says National Party Associate Health spokeswoman (Pharmacare) Jackie Blue. “This is shaping up to be the same sort of debacle that we saw when Ritalin was substituted for Rubifen without all the necessary homework.” For the past several weeks there have been media reports that a number of patients are having problems with Eltroxin. Eltroxin is used as a treatment for an under performing thyroid gland, which boosts the level of thyroid hormone essential to keep the body functioning normally. “I spoke to Southland Pharmacist Allan Campbell who told me that Medsafe had informed him they had not requested bio-equivalence studies to check blood levels that the new formulation Eltroxin was working effectively. “Subsequent blood tests from affected patients had proven that their normal dose was ineffective. This is all strangely familiar.” Last year there were numerous complaints from patients when Pharmac switched from Ritalin, a medication used to treat attention deficit disorders, to a cheaper sole supply drug, Rubifen. “Many children did not tolerate the switch to Rubifen and it turned out the bio-equivalence studies that had been done were done several years earlier on Irish males. “Following the public uproar, Pharmac said it would be reviewing sole supply contracts and would look at a system where 1% of patients who could prove that they could not tolerate the switch would have the option of returning to their original medication. “But all this seems to have been rhetoric. Nothing has happened and now we have yet another patient group suffering.” <http://www.scoop.co.nz/stories/PA0806/S00268.htm> -- Rod Hypothyroidism is a seriously debilitating condition with an insidious onset. Although common it frequently goes undiagnosed. <www.thyromind.info> <www.thyroiduk.org> <www.altsupportthyroid.org>
From: Rod on 19 Jun 2008 02:37
john_glenn(a)xtra.co.nz wrote: <> > > John here > I have been having trouble with headaches, vision, mood changes etc. > Had consulted my Dr who could not really give an answer to the > conditions I am experiencing but prescribed I-Profen up to 6 per day > for pain. Over this last week they have not had any effect in pain > relief. I went back today to see the Dr and explained to him what I > had seen written and heard via the internet about this Eltroxin and > suggested to him that this could be what is causing the headaches etc. > I asked if he had heard anything about this drug and side-effects > being experienced by other patients of his. He was not aware of any > problems associated with Eltroxin Tabs and there was noting in the > lastest mail-out from MEDSAFE NZ. I then asked for him to write > another script for thyroxin tabs to take to the pharmacy to be > filled. > There, I was told that there is NO substitute in New Zealand for > Eltroxin and the problems being experienced by patients who have > reacted to the new formular is a world wide problem. The pharmisist > further went on to say, > (a) you have to keep taking the current tabs as prescribed (3 x 50mcg > per day), and > (b) go back to your Dr to be refered to a specialist and > (c) there is no alternative to Eltroxin. > Will keep the group posted as to the results of the next visit. > 19th June 2008 John, Thanks for that. Odd, the earliest reports mentioned the possibility of getting Goldshield's version - albeit privately (nop idea how your system works, I'm afraid). Hopefully you will have noticed my other post in this thread - further reports. -- Rod Hypothyroidism is a seriously debilitating condition with an insidious onset. Although common it frequently goes undiagnosed. <www.thyromind.info> <www.thyroiduk.org> <www.altsupportthyroid.org> |