Tresiba: Another Useless And Potentially Dangerous Diabetes Drug

| July 9, 2015 | Comments (7)

People with type 1 diabetes need to use insulin medication daily and, as I pointed out in an earlier post here, more and more type 2 diabetics are also being prescribed insulin. Developing new ‘insulin analogues’ – drugs that do the same job as insulin in the body – has become a major growth area for big Pharma. Leading the field is Danish drugs giant Novo Nordisk with its long-acting insulin analogue Tresiba.

But a damning new report from the German Institute for Quality and Efficiency in Health Care (IQWiG) has found “no hint of added benefit” in children and adolescents taking Tresiba and an increased incidence of serious side effects in girls. Meanwhile in America, the FDA has been too worried about Tresiba’s cardiovascular risks to authorise its use.

Three years ago, the European Medicines Agency (EMA) approved the use of Tresiba as a once daily injection for adults with type 1 or type 2 diabetes. Novo Nordisk has marketed it aggressively on the basis that its long duration of action gives patients more flexibility about when to inject it. Tresiba is currently prescribed in England and Wales, but not in Scotland (the Scottish Medicines Consortium decided its benefits did not justify its cost).

In America, though, the FDA refused to authorise Tresiba, because of concerns about raised cardiovascular risks. Their decision was based on studies involving 5,794 people treated with the drug, showing that it increased the risk of major cardiovascular events, such as heart attack and stroke, by a whopping 67 per cent.1 At the time, eminent diabetes specialists in the UK, USA and Denmark called on the EMA to suspend its authorisation of Tresiba until the FDA’s concerns had been investigated.2 But sadly, their plea was ignored.

The FDA asked Novo Nordisk to conduct further cardiovascular safety studies on Tresiba. The manufacturer has now submitted a revised dossier, on the basis of which the FDA could well give its approval for Tresiba to be used in the US, by October this year. To me it seems ludicrous that when a new drug appears to present serious health risks, these are not investigated by an independent body; instead, the manufacturer is allowed to design and fund new trials and to massage the statistics until the problem magically disappears!

While Tresiba was originally only approved for use by adults, in January this year the EMA extended its approval to adolescents and children as young as one year. But the data Novo Nordisk submitted to support this extension of use has surprised and worried the German health care institute IQWiG. The dossier not only showed no added benefit from the drug for children with type 1 diabetes, it also showed that in girls there was a greater risk of serious adverse events than with standard medications.3

While severe side effects occurred within 12 months in around three per cent of girls using standard insulin therapy, that figure shot up to fifteen per cent with Tresiba – a massive five-fold increase in risk. And since Novo Nordisk provided no data relating to type 2 diabetes in young people, its effectiveness and safety in under-18s with this condition cannot even be evaluated. So here is another new diabetes drug that is little or no better than existing medications in terms of relieving symptoms, preventing death or improving quality of life. And it comes with evidence of cardiovascular side effects in adults with type 2 diabetes and serious adverse events (the nature of which were not specified in the IQWiG report) in girls with type 2 diabetes.

You can, and should, steer clear of Tresiba

As I mentioned here, high use of insulin medications has been linked to increased mortality from heart disease and cancer. In people with type 2 diabetes, adding insulin to standard medication (usually metformin) has recently been shown to double the risk of a cardiovascular event in moderate insulin users and to triple it in high insulin users.4

The message on Tresiba is clear:

  • if you have type 1 diabetes, stick to a tried-and-tested form of insulin with a good safety profile (your doctor should be able to advise you on this).
  • if you have type 2 diabetes, think very hard before agreeing to any form of insulin treatment; type 2 can usually be reversed, and your overall health improved immensely, by keeping to a programme of diet and exercise. See my earlier posts here and here for information and inspiration.

If you are fighting ‘midriff bulge’, you can probably think of several factors that contribute to it – poor diet and lack of exercise of course, and perhaps hormonal influences, too. But traffic noise? In my next blog post I’ll be telling you about a recent study that shows a link between waist circumference and ‘noise pollution’.

Wishing you the best of health,

Martin Hum
PhD DHD Nutritionist
for Real Diabetes Truth

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References

  1. FDA Endocrinologic and Metabolic Drugs Advisory Committee (2012). www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/EndocrinologicandMetabolicDrugsAdvisoryCommittee/UCM330923.pdf
  2. Schmidt TA, Rosen CJ, Yudkin JS. Re: Bad medicine: the way we manage diabetes. BMJ. 2013;   http://www.bmj.com/content/346/bmj.f2695/rr/648949
  3. IQWiG Press Release 01/06/2015. Insulin degludec: no hint of added benefit in children and adolescents. https://www.iqwig.de/en/press/press-releases/press-releases/insulin-degludec-no-hint-of-added-benefit-in-children-and-adolescents.6716.html
  4. Stoekenbroek RM, Rensing KL, Bernelot Moens SJ. High daily insulin exposure in patients with type 2 diabetes is associated with increased risk of cardiovascular events. Atherosclerosis. 2015; 240(2):318-323.


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Category: Diabetes

Comments (7)

Testimonials are based on the personal experience of individuals. Results are not typical and the potential benefits of taking any drug or supplement may vary depending on your individual needs and health requirements. Please consult your GP before making any changes to your medical regimen.

  1. Cinniamon Hoover says:

    i was taking Lantus twice a day for several years. I changed doctors she suggested Tresiba, it was started once a day. About 2 months into new insulin I started falling out of bed, having memory and confusion issues. I ended up in hospital for 5 days with new dx of seizures, which possibly caused by low blood sugars which I had never had a problem with and there is no family hx of seizures. While in hospital I started back on Lantus and am still off work. I would not suggest this med to anyone

  2. Kimberly Rosenthal says:

    Started taking Tresiba three days ago and I’ve been having a lot of problems with gas in my stomach to the point I don’t want to eat. Making me sick. Stopping this drug. Going back to Levemir.

  3. frank says:

    I fully agree, stay away from tresiba. I am a type 1 diabetic. As soon as I started using it, I caught the worst cold in the history of man, and nothing i could do would make it go away. I even went to the doctor, he told me my lungs were crystal clear, although i could not stop coughing. After a few weeks, and no one near me was catching it, i began to wonder why i was the only one sick with this NASTY cold, lost my voice, and couldn’t stop coughing at night. The only thing i did different is go from levemir to tresiba, so i stopped the tresiba, within hours i began to feel better , and by 48 hours my cold was miraculously “cured”. This cold was so severe, i don’t want to have another one for 2 years. And when i looked at their website, naso pharangytis was an adverse effect in a plurality of type 1 patients and a few type 2. I will never go off of levemir again

    • Jamil Taylor says:

      This is only interesting in that http://www.tresiba.com does not at all list nasopharangytis as a side effect. Which site do you refer to?

    • Lisa says:

      I went onto Tresiba about a month ago from Levemir as I am a type 1 diabetic and I started to get a very sore throat and chest. I then started to get heart palpitations and kept feeling that I was breathless and my chest and throat were on fire and feel breathless. This has got so bad that I have had to give up all activities and it is also very uncomfortable. I have felt so ill that I decided to do some research as all these symptoms started when I changed to Tresiba. I now am swapping straight back to levemir and hoping that I feel better soon.

  4. Jamil Taylor says:

    I am a type 1 diabetic who has been injecting insulin now for over 40 years. I have had good experience with Novo Nordisk’s Levemir insulin, and I was pleased to see them release a longer lasting basal insulin. I started taking Tresiba 17-Feb-2015 and learned the correct dosage I require by 20-Feb-2015. Shortly after starting this new medication, I got a very severe respiratory infection. At first, I thought I caught the flu. However, my condition quickly worsened to pneumonia in both lungs. This was confirmed with chest x-rays.

    What I learned later directly from Novo Nordisk is that type 1 diabetic patients who take Tresiba have a 11.9% chance of getting an upper respiratory tract infection. This warning is not included with the medication at all, and Novo Nordisk decided to mail it to me many days after I had already been injecting the medication. Pneumonia is a very serious condition, and it made me very sick. Also, I had received my usual pneumonia vaccinations as directed by my doctor. This vaccination was useless against the havoc that Tresiba caused me.

    I am now looking to switch back to Levemir and stop using Tresiba. I agree with this article to avoid this new insulin.

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Testimonials are based on the personal experience of individuals. Results are not typical and the potential benefits of taking any drug or supplement may vary depending on your individual needs and health requirements. Please consult your GP before making any changes to your medical regimen.




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