Reporting Adverse Drug Reactions - The Yellow Card

Reporting Adverse Drug Reactions - The Yellow Card

About a month ago (7th January 2013) the MHRA published a report on Levothyroxine.

One of the reasons given for producing the report was that they had received a number of reports (Adverse Drug Reactions – reported by the Yellow Card system). And the number had grown considerably over the past few years.

When you look at the chart in the report, you can see that they only reached about 50 a year. This, without meaning to diminish their importance, is a small number.

Although I don’t sit here counting them up, but I feel that I can read at least fifty reports of adverse reactions to medicines, often but not always Levothyroxine, each month! And busy as we are, the number of members is still only a tiny percentage of those in the UK who have thyroid disorders.

I was very pleased that the MHRA did take notice and produce their report. But how much more notice would they take if they got not 50, but 500, or 5,000?

The absolute worst thing for us to do would for everyone here to suddenly invent Yellow Card reports! Maybe, though, if you genuinely feel that you have suffered an adverse reaction, you could see your way to making a proper report? And that applies whether it is is Levothyroxine or any other medicine. You do not need a degree in medicine or chemistry. Simply tell it in your own words as clearly and honestly as possible. Link appears below.

Extract from MHRA report:

The MHRA review of marketed levothyroxine tablet products was undertaken following the receipt of a small but persistent number of clinical and quality concerns from healthcare professionals and patients. These concerns focused on whether all tablet formulations of levothyroxine were equivalent and whether possible lack of equivalence might be explained by differences in levothyroxine content. While the number of these reports remains extremely low in comparison to the extent of usage of levothyroxine, queries directed to the MHRA have increased since 2006, suggesting a persistent level of concern from healthcare professionals and the patient population.

For levothyroxine products, these queries are mirrored by Adverse Drug Reaction (ADR or “Yellow Card”) reports which have also increased in the past 4 years as shown in Figure 1.

The “Yellow Card” scheme is the UK’s system for collecting and monitoring suspected adverse drug reactions including loss of efficacy and concerns with the quality of medicines. Details on how to submit a “Yellow Card” report are provided in the following link to the relevant area of the MHRA website.

mhra.gov.uk/Safetyinformati...

The reported ADRs cover a wide range, from lack of efficacy and changes in thyroid function tests to nonspecific complaints such as fatigue, alopecia and pain. Out of 453 UK spontaneous ‘suspected’ ADR reports associated with levothyroxine, 87 reports describe reactions of lack of efficacy, product substitution issues, thyroid disorders, and thyroid and pituitary analyses investigation results associated with levothyroxine. In 15 ADR reports the reporter stated that the reactions occurred upon switching between different brands of levothyroxine, and 2 reports relate to issues with interchangeability between liquid and tablet forms. As product names are often not reported, ADRs associated with product interchangeability and/or reformulation may not always be identified.

Full report here:

mhra.gov.uk/home/groups/pl-...

Rod

Picture is a big yellow taxi because the word "yellow" so often reminds me of Joni Mitchell

30 Replies

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  • well, levo was yuck for me so I have filled in a yellow card and it was in last 3 months :D

  • So you must have been the one who made the count reach 50! :-)

  • YAY :D ;)

  • Done! I think joint pain severe enough for the GP to suspect RA is a significant enough side-effect, not to mention the fact that it didn't work ;)

  • I submitted to Yellow Card reports today. - Very important to do if you have any adverse effects

  • MHRA will wonder what happened over the weekend! :-)

  • (also in the film 2 weeks notice - film with lovely Sandra Bullock)

    off on a tangent as usual for me, I have a yellow cab (an unpaid 2 seater) :D

  • 'you don't know what you've got 'til it's gone, give me spots on my apples!

    I suppose I have always been a hippy, and luckily avoided horse burgers too! ;)

  • I expect levo has horse meat it in it!

  • How do I know if my problems are a result from the Levo or part of my hypothyroid?

  • It can be very difficult.

    Quite a lot of people here have repeatedly tried levothyroxine, had problems, and only eventually felt better with desiccated thyroid, Liothyronine (T3) or some combination. That would appear to point to the levothyroxine. Or if one make is OK, but switching to another make always causes some reaction.

    All we can ever do is be honest, accurate reporters and put in reports in good faith.

    Even if it were not the levothyroxine, then maybe the Patient Information Leaflet should be changed to list the reaction(s) and even explain.

  • Hi everyone ! I'm very new here so this is my first 'comment' ! Thanks so much for the levo report. Had my goitre, lumps and gland removed in 1990 and only ever have an annual blood test. Reading about others makes me aware that I'm fairly lucky having just a few problems. But. . . Now Goldshield levo has 'disappeared' I've had to try Eltroxin ! As an asthmatic I'm used to chest pain but nothing as bad as this. The yellow card is done and I'm on another levo. Time and the next blood test will tell ! Thanks everyone for the help I've found here over the last few weeks. I wish I'd known about you before ! Florence z.

  • Have a look here:

    thyroiduk.org.uk/tuk/treatm...

    It details all current UK thyroid hormone medicines. Goldshield merely got renamed Mercury Pharma. And all their levothyroxine products are the same including Eltroxin.

    This does not, of course, exclude inter-batch differences, etc.

    Well done on the Yellow Card.

  • Thanks for swift reply Helvella, nice to feel there are people who care. Unfortunately, for me anyway, I am so sensitive to any minute deviation or change in a product that even though they are 'all the same' my system decides they aren't and goes into overdrive. My brilliant GP who for ages didn't believe me has proved it to himself through blood tests, peak flow charts etc. So I'm one of the lucky ones. Reading the comments my heart goes out to so many people going through what I did before I had the goitre and my then GP finally had to admit it was thyroid not clinical depression and stress causing me to weigh 5stone and be so unhappy !

  • I 100% did not mean the Mercury Pharma products are the same as Actavis and/or Wockhardt (in case it came out like that). Merely that Mercury Pharma stated all their products are the same. The tablets have the exact same markings as each other.

    But some people are indeed extraordinarily sensitive.

    :-)

  • In case you have mis-understood, It is the levothyroxines made and supplied by MercuryPharma (used to be called Goldshield) that are 'all the same'. So, if you are given a packet that says Eltroxin, it is the same pills inside as the packet that says MercuryPharma. This is as stated by MercuryPharma.

    Many of us are extremely sensitive to medications and supplements, so we know what you're dealing with :)

    The other main UK levothyroxin manufacturer is Actavis. If you don't do well on MercuryPharma levo, you might do better on Actavis.

    We've had a few people say the only UK levo they can tolerate is Wockhardt, who only manufacture 25mcg tablets. Which makes life difficult because they then have to take multiple tablets to get the relevant does (e.g. four tablets to get 100mcg dose).

  • Thanks, yes I understood you. And you are quite right. A guy at Mercury Pharma got really cross with me for trying to explain to him what you've picked up straightaway !

  • So glad I'm not the only one to be sensitive to things, I thought I was a bit of a freak ! Interestingly it was being given Wockhardt back in May last year that started off my problems. I also take 25mcg tabs in multiples but its never been clear why. To be fair I've never asked anyone, just assumed this was standard practice.

  • No,being prescribed multiples of 25mcg is not standard practise. In the UK, we have three doses available: 25mcg, 50mcg and 100mcg.

    So, if you need anything other than those doses, then you are obviously going to need at least two tablets.

    Then problems can arise because not all manufacturers make all dose sizes. So you end up being given different brands. e.g. a 25mcg Wockhardt plus a 50 or 100mcg of another brand. This is not good for many patients.

    And this is where MercuryPharma triumph because they cover all three dose sizes. So if you can tolerate their levo, you're lucky. If you can only tolerate say Actavis, and need a 25mcg tablet, you have no choice but to cut a 50mcg in half, or take the 50mcg on alternate days only.

    It's a big problem that's been going on for years because everyone was told that all levos are the same. The average GP / endo is only just beginning to accept the problem really does exist. Same story with pharmacies, who are only recently realising that if they want your repeat custom, they need to supply you with whichever brand you insist on having!

  • I'm finding all this info totally mind boggling! After 30 years of coping on my own and continually accepting that once you have a 'thyroid' problem life will never be the same again, trying to convince medical professionals that the symptoms can't just be alleviated by a tablet and a blood test and wondering why no-one seems to listen to the patient any more, let's hope there may now be some light at the end of the tunnel. It's long overdue!

  • I hear you! The only saving grace of all this is knowing that it's not just a UK problem. Thyroid patients across the (English speaking at least) world are all fighting this battle.

    You may or may not have realised that this support group is managed by volunteers on behalf of the small charity Thyroid UK ( thyroiduk.org ), who are working hard towards changing things (as are other organisations of course).

    So yes, thanks to the instant communication via the internet that we have now, *we will* get the changes we all so desperately need! This problem is not going to go away, and can no longer be hidden like it used to be, so the medical profession have no choice but to face up to it :)

  • "While the number of these reports remains extremely low in comparison to the extent of usage of levothyroxine,"

    Could this be because there is no other sort of thyroxine considered or that patients are ignorant of their rights to fill in a yellow form or that patients symptoms are being fobbed off? It is actively discouraged at my doctors surgery to fill in yellow forms!!

  • On the basis that Yellow Card reporting is handled entirely by the person reporting the ADR and the MHRA, how on earth does your surgery have any impact whatsoever on what you decide to do? It is confidential. And you do not have to pick up a form at a surgery in these days of the internet!

    In my book, actively discouraging should be regarded as malpractice and reported as such. (Maybe no-one else will agree with that?)

    Certainly patients have been ignorant of their rights - which was one reason for this blog.

  • Yes, I had realised that you are volunteers which makes the help even more appreciated. I suppose, in fairness, we must always remember that the initials GP stand for General Practioner which title covers all aspects of medical care so expertise in any one area is going to be rare. However with thyroid function being such an essential and important part of optimum health it would be good if the qualifications could include at least a rudimentary knowledge of the effect on the patient when this function is compromised. If it wasn't so important we wouldn't be on the relatively short list for free medication would we ?

  • Don't disagree - but in some practices the rate of hypothyroidism is 3% or more (virtually all are over 2%). Which is a very high level. After all, many disorders are unlikely to last the decades that are so very common in hypothyroidism.

    That needs to be fed back into training, continuing professional development, etc.

  • A quick reply here as have to go out now :) Of course your point about GPs is totally understood and accepted. But the so called specialists (endocrinologists) are the same. They are the ones who have called the shots when GPs have actually tried to help patients. You'll see time and time again here how unhelpful endos have been and still are. My own GP was willing to trial me on other thyroid medications, but both an NHS and a private endo said 'No', and then the PCT refused to fund even when my GP was prepared to go against the endo advise!

    We'll get there eventually! :)

  • Yup, done, Thank you for reminding us and giving us the link.

  • The last time I filled in a yellow form was several years back and there was no choice but to get one from the surgery, that was for a complaint about statins which I have since discovered should not be prescribed for hypo patients!

  • Done. :D Great post Rod. I had no idea you could do this.

    I've also had this sent to my GP - a useful thing to have put on your medical file in my view as they will be much more likely to believe you have problems if they see you've actually reported it.

    I'm one of those with Levo problems but am fine with NDT and synthetic T3.

  • I didn't know about the yellow card system either, thanks Rod.

    Great Joni Mitchell song too!

    Cheers, Andy

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